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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02303821




Registration number
NCT02303821
Ethics application status
Date submitted
20/11/2014
Date registered
1/12/2014
Date last updated
16/07/2024

Titles & IDs
Public title
Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Scientific title
Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Secondary ID [1] 0 0
2014-001633-84
Secondary ID [2] 0 0
CFZ008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia (ALL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Phase 1b: Dose Escalation 1 - Subjects will receive carfilzomib in combination with induction chemotherapy, comprising an R3 backbone of dexamethasone, mitoxantrone, PEG asparaginase, and vincristine.

Subjects will have a 1 week carfilzomib single agent Lead in Window prior to the Induction Cycle.

Subjects will receive a 4 week cycle of induction chemotherapy and have the option to receive a 4 week cycle of consolidation chemotherapy (Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if stable disease or better response is achieved at the end of the Induction Cycle.

Experimental: Phase 1b: Dose Escalation 2 - Subjects will receive carfilzomib in combination with induction chemotherapy, comprising a VXLD backbone of vincristine, dexamethasone, PEG asparaginase, and daunorubicin.

Subjects will receive a 4 week cycle of carfilzomib and induction chemotherapy and then have the option to receive a 4 week cycle of consolidation chemotherapy (Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if stable disease or better response is achieved at the end of the Induction Cycle.

Experimental: Phase 2: Aged = 12 months at screening - All subjects aged = 12 months at screening.

Subjects will receive the recommended phase 2 dose (RP2D) of carfilzomib determined in Phase 1b.

Subjects will receive a 4 week cycle of carfilzomib and induction chemotherapy comprising of a VXLD backbone of vincristine, dexamethasone, PEG asparaginase and daunorubicin. Subjects will then have the option to receive a 4 week cycle of carfilzomib in combination with consolidation chemotherapy Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine) if subjects showed no disease progression at the end of the Induction Cycle.

Experimental: Phase 2: Aged < 12 months at screening - All subjects aged \< 12 months at screening.

Subjects will receive the recommended phase 2 dose (RP2D) of carfilzomib determined in Phase 1b.

Subjects will receive a modified 5 week cycle (based on Interfant-06) of carfilzomib and induction chemotherapy comprising of a VXLD backbone of vincristine, dexamethasone, PEG asparaginase and daunorubicin. Subjects will then have the option to receive a 5 week cycle (modified based on Interfant-06) of carfilzomib in combination with consolidation chemotherapy Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if subjects showed no disease progression at the end of the Induction Cycle.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1b: Number of Subjects who Experience One or More Adverse Events (AE)
Timepoint [1] 0 0
36 months
Primary outcome [2] 0 0
Phase 1b: Number of Subjects who Experience One or More Serious Adverse Events (SAEs)
Timepoint [2] 0 0
36 months
Primary outcome [3] 0 0
Phase 1b: Number of Subjects who Experienced a Clinically Significant Change from Baseline in Key Laboratory Analytes
Timepoint [3] 0 0
36 months
Primary outcome [4] 0 0
Phase 1b: Number of Subjects who Experience a Clinically Significant Change from Baseline in Vital Signs
Timepoint [4] 0 0
36 months
Primary outcome [5] 0 0
Phase 1b: Number of Subjects who Experience a Clinically Significant Change from Baseline in Physical Findings
Timepoint [5] 0 0
36 months
Primary outcome [6] 0 0
Phase 1b: Time to Toxicity
Timepoint [6] 0 0
36 months
Primary outcome [7] 0 0
Phase 1b: Maximum Tolerated Dose (MTD)
Timepoint [7] 0 0
36 months
Primary outcome [8] 0 0
Complete Remission (CR) after induction therapy
Timepoint [8] 0 0
Within 14 days of Induction and/or Consolidation cycle completion
Primary outcome [9] 0 0
Complete Remission (CR) Rate After Induction Therapy in Subjects Aged Less Than 12 Months at Screening
Timepoint [9] 0 0
From Day 36 up to a maximum of Day 50
Secondary outcome [1] 0 0
Phase 1b: Maximum plasma concentration (Cmax)
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Phase 1b: Total Plasma Exposure - Area Under the Curve (AUC)
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Phase 1b: Number of Subjects who Experience Complete Remission (CR) or Complete Remission with Incomplete Hematological Recovery (CRi)
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Phase 1b: Minimal Residual Disease (MRD) Status
Timepoint [4] 0 0
36 months
Secondary outcome [5] 0 0
Phase 2: Number of Subjects who Experience a Treatment-emergent Adverse Event (TEAE)
Timepoint [5] 0 0
29 months
Secondary outcome [6] 0 0
Phase 2: Number of Subjects who Experience a Treatment-related Adverse Event
Timepoint [6] 0 0
29 months
Secondary outcome [7] 0 0
Phase 2: Number of Subjects who Experience a Severe Adverse Event
Timepoint [7] 0 0
29 months
Secondary outcome [8] 0 0
Phase 2: Number of Subjects who Experience a Laboratory Abnormality
Timepoint [8] 0 0
29 months
Secondary outcome [9] 0 0
Phase 2: Number of Subjects who Experience Complete Remission (CR), Complete Remission with Incomplete Recovery of Platelets (CRp), CR with Partial Hematological Recovery (CRh) or Complete Remission with Incomplete Hematological Recovery (CRi)
Timepoint [9] 0 0
29 months
Secondary outcome [10] 0 0
Phase 2: Event Free Survival (EFS)
Timepoint [10] 0 0
29 months
Secondary outcome [11] 0 0
Phase 2: Overall Survival (OS)
Timepoint [11] 0 0
29 months
Secondary outcome [12] 0 0
Phase 2: Duration of Response (DOR)
Timepoint [12] 0 0
29 months
Secondary outcome [13] 0 0
Phase 2: Minimal Residual Disease (MRD) Status in Subjects Achieving CR
Timepoint [13] 0 0
29 months
Secondary outcome [14] 0 0
Minimal Residual Disease (MRD) Status in Subjects with Complete Remission (CR), CR with Incomplete Recovery of Platelets (CRp), CR with Partial Hematological Recovery (CRh) or CR with Incomplete Hematological Recovery (CRi)
Timepoint [14] 0 0
29 months
Secondary outcome [15] 0 0
Number of Subjects who Experience a Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR-T)
Timepoint [15] 0 0
29 months
Secondary outcome [16] 0 0
Phase 2: Number of Subjects who Experience a Clinically Significant Change from Baseline in Laboratory Analytes
Timepoint [16] 0 0
29 months
Secondary outcome [17] 0 0
Number of Subjects who Experience Complete Remission (CR), CR with Incomplete Recovery of Platelets (CRp), or CR with Incomplete Hematological Recovery (CRi) After Consolidation Therapy in Subjects Aged Greater Than or Equal to 12 Months at Screening
Timepoint [17] 0 0
Day 29 and 45
Secondary outcome [18] 0 0
Number of Subjects who Experience Complete Remission (CR), CR with Incomplete Recovery of Platelets (CRp), or CR with Incomplete Hematological Recovery (CRi) After Consolidation Therapy in Subjects Aged Less than 12 Months at Screening
Timepoint [18] 0 0
Day 36 to 50
Secondary outcome [19] 0 0
Phase 2: Maximum Plasma Concentration (Cmax)
Timepoint [19] 0 0
29 months
Secondary outcome [20] 0 0
Phase 2: Area Under the Concentration-time Curve (AUC)
Timepoint [20] 0 0
29 months
Secondary outcome [21] 0 0
Phase 2: Half-life (t1/2) of Carfilzomib
Timepoint [21] 0 0
29 months

Eligibility
Key inclusion criteria
Phase 1b Key

1. Age 21 years or younger at the time of initial ALL diagnosis and age > 1 year at the time of study treatment initiation.
2. Subjects must have a diagnosis of relapsed or refractory ALL with = 5% blasts in the bone marrow (M2 or M3 disease), with or without extramedullary disease.

-To be eligible, subjects must have had 1 or more prior therapeutic attempts, defined as:
* Early first relapse (< 36 months from original diagnosis) after achieving a CR (B-ALL) or first relapse any time following the original diagnosis after achieving a CR (T-ALL)
* First refractory bone marrow relapse occurring any time after original diagnosis after achieving a CR (ie, =1 failed attempt to induce a second remission) OR
* Relapse after achieving a CR following the first or subsequent relapse (i.e., = 2 relapses) OR
* Failing to achieve a CR from original diagnosis after at least 1 induction attempt
3. Subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment.
4. Subjects must have a serum creatinine level that is = 1.5 × institutional upper limit of normal (ULN) according to age. If serum creatinine level is > 1.5 × ULN, the subject must have a calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) = 70 mL/min/1.73 m2.
5. Adequate liver function, defined as both of the following:

* Total bilirubin = 1.5 × institutional ULN except in the presence of Gilbert Syndrome
* Alanine aminotransferase (ALT) = 5 × institutional ULN
6. Performance status: Karnofsky or Lansky scores = 50 for subjects > 16 years old or = 16 years old, respectively.

Phase 2

1. Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated, except for standard of care local testing as permitted per protocol.
2. Age greater than or equal to 1 month to less than 21 years. Subjects greater than or equal to 18 years must have had their original diagnosis at less than 18 years of age.
3. Subjects must be diagnosed with relapsed or refractory relapsed ALL.
4. Subjects must have a documented first remission, less than 5% blasts in the bone marrow (M1 bone marrow) and no evidence of extramedullary disease.
5. T-cell ALL with bone marrow relapse (defined as greater than or equal to 5% leukemia blasts in bone marrow) or refractory relapse with or without extramedullary disease.

OR B-cell ALL bone marrow relapse or refractory relapse (defined as greater than or equal to 5% leukemia blasts in bone marrow) after having received a targeted B-cell immune therapy (eg, blinatumomab, inotuzumab or a CAR-T therapy) with or without extramedullary disease..
6. Adequate liver function: bilirubin less than or equal to 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) less than or equal to 5 x ULN.
7. Adequate renal function: serum creatinine less than or equal to 1.5 x ULN or glomerular filtration rate (GFR) greater than or equal to 70 mL/min/1.73 m^2; or for children less than 2 years of age, greater than or equal to 50 mL/min/1.73 m^2.
8. Adequate cardiac function: shortening fraction greater than or equal to 30% or ejection fraction greater than or equal to 50%.
9. Karnofsky (subjects greater than or equal to 16 years of age) or Lansky (subjects 12 months to less than 16 years of age) performance status greater than or equal to 50%.
10. Subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment (for example: recovery from gastrointestinal toxicity may occur more rapidly than less reversible organ toxicities such as sinusoidal obstruction syndrome or non-infectious pneumonitis, for serious prior toxicities recommended discussion with Amgen medical monitor).
11. Life expectancy of greater than 6 weeks per investigator's judgement at time of screening.

Phase 1b Key
Minimum age
1 Month
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known allergy to any of the drugs used in the study (Subjects who have had a previous allergy to PEG-asparaginase and if able, may receive Erwinia asparaginase at the investigator's discretion)
2. Known allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
3. Left ventricular fractional shortening < 30%
4. History of = Grade 2 pancreatitis
5. Active graft-versus-host disease requiring systemic treatment
6. Positive culture for or other clinical evidence of infection with bacteria or fungus within 14 days of the initiation of study treatment
7. Down Syndrome
8. Prior therapy restrictions:

* Subjects must have completed therapy with granulocyte-colony stimulating factor (G-CSF) or other myeloid growth factors at least 7 days before study treatment initiation, or at least 14 days before study treatment initiation, if pegylated myeloid growth factors were administered.
* Subjects must have completed any type of active immunotherapy (e.g., tumor vaccines) at least 42 days before study treatment initiation.
* Subjects must have received the last dose of a non-monoclonal antibody biologic agent at least 7 days before study treatment initiation.
* At least 3 antibody half-lives must have elapsed since the last dose of monoclonal antibody (e.g., 66 days for rituximab and 69 days for epratuzumab) before subjects may initiate study treatment.
* Subjects must not have received other antineoplastic agents with therapeutic intent, excluding hydroxyurea and antimetabolites administered as part of maintenance chemotherapy, within 7 days prior to study treatment initiation.
9. Hepatitis B infection with positive hepatitis B DNA

Phase 2

1. Prior treatment with carfilzomib.
2. Intolerance, hypersensitivity, or inability to receive any of the chemotherapy components of the VXLD regimen. An exception is allowed for allergy to asparaginase products if Erwinia asparaginase is unable to be administered,
3. Autologous HSCT within 6 weeks prior to start of study treatment.
4. Allogeneic HSCT within 3 months prior to start of study treatment.
5. Active GVHD requiring systemic immune suppression.
6. Less than 30 days from discontinuation of immune suppressive therapy administered for the treatment of acute or chronic GVHD.
7. Isolated extramedullary relapse.
8. Positive bacterial or fungal infection within 14 days of enrollment (except for documented line infection, line has been removed, and blood culture after line removal is negative for 5 days prior to first dose of induction therapy). Antibiotics may be administered for prophylaxis as per institutional standards up to and after enrollment.
9. Subjects with less than 3 antibody half-lives since the last dose of monoclonal antibody (eg, 66 days for rituximab, 69 days for epratuzumab, inotuzumab for 36 days), prior to first dose of investigational product must be discussed with the Amgen medical monitor and may be allowed to enroll based on extent of disease or evidence of rapidly rising peripheral or bone marrow blast counts.
10. Cell-based immunotherapy (eg, donor leucocyte infusion, CAR-T cells, tumor vaccines) within 42 days prior to first dose of investigational product. If the Amgen medical monitor agrees, an exception may be granted to the 42-day requirement for subjects with rapidly rising peripheral or bone marrow blast counts.
11. Down's syndrome.
12. Presence of another active cancer.
13. History of grade greater than or equal to 2 pancreatitis within 6 months to screening.
14. Unresolved toxicities from prior anticancer therapy, defined as not having resolved to CTCAE version 4.03 grade 1 or to levels dictated in the eligibility criteria apart from alopecia or toxicities from prior anticancer therapy that are considered irreversible and do not trigger another exclusion criterion (defined as having been present and stable for greater than 4 weeks).
15. Antitumor therapy (chemotherapy, investigational agents, molecular-targeted therapy) within 7 days of day 1 of induction. Exception: hydroxyurea to control peripheral blood leukemic cell counts is allowed until start of investigational product.
16. Active viral infection, including but not limited to cytomegalovirus (CMV), Hepatitis B infection with positive serum hepatitis surface antigen or hepatitis B DNA, HIV, Hepatitis C with detectable hepatitis C RNA. Subjects who have previously received a stem cell transplant must be screened for CMV infection, unless both subject and donor are known to be CMV negative.
17. Currently receiving treatment in another investigational device or product study, or less than 14 days since ending treatment on another investigational device or product study.
18. Uncontrolled arrhythmias or screening ECG with corrected QT interval (QTc) of greater than 470 msec.
19. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
20. Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of any study treatment or for 12 months after last dose of cyclophosphamide if administered during optional consolidation cycle.
21. Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 6 months after the last dose of any study treatment or for 12 months after last dose of cyclophosphamide if administered during optional consolidation cycle.
22. Female subjects of childbearing potential with a positive pregnancy test assessed at Screening by a serum or urine pregnancy test.
23. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use a condom with spermicide during treatment and for an additional 6 months after the last dose of any study treatment, even if they have undergone a successful vasectomy.
24. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom with spermicide during treatment, for duration of pregnancy, and for an additional 6 months after the last dose of any study treatment.
25. Male subjects unwilling to abstain from donating semen or sperm during treatment and for an additional 6 months after the last dose of any study treatment.
26. Known allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib; for a complete listing of Captisol-enabled drugs, see the Ligand Pharmaceuticals, Inc. website).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2024
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Sydney Childrens Hospital - Randwick
Recruitment hospital [2] 0 0
The Childrens Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Queensland Childrens Hospital - South Brisbane
Recruitment hospital [4] 0 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [5] 0 0
Perth Childrens Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
6909 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
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United States of America
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Utah
Country [16] 0 0
United States of America
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West Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Austria
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Wien
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Brazil
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Bahia
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Brazil
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Distrito Federal
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Brazil
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Paraná
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Brazil
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Pernambuco
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Bulgaria
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Sofia
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Canada
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Quebec
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Chile
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Santiago de Chile
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Chile
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Santiago
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Colombia
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Cesar
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Colombia
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Valle Del Cauca
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Czechia
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Brno
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Denmark
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Kobenhavn O
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France
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Bordeaux Cedex
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France
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Lille
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France
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Paris
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France
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Toulouse Cedex 9
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France
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Vandoeuvre les Nancy Cedex
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Greece
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Athens
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Greece
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Goudi
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Greece
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Patra
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Greece
State/province [42] 0 0
Thessaloniki
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Hong Kong
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Kowloon Bay
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Israel
State/province [44] 0 0
Tel Hashomer
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Italy
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Bari
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Italy
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Catania
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Italy
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Genova
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Italy
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Monza (MB)
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Italy
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Napoli
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Italy
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Padova
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Italy
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Pavia
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Italy
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Roma
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Italy
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Torino
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Korea, Republic of
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Seoul
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Korea, Republic of
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Yangsan-si, Gyeongsangnam-do
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Puebla
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Netherlands
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Utrecht
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Norway
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Oslo
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Warszawa
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Poland
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Wroclaw
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Poland
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Zabrze
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Romania
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Timisoara
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Saudi Arabia
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Riyadh
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Singapore
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Singapore
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South Africa
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Johannesburg
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Spain
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Cataluña
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Spain
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Madrid
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Sweden
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Solna
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Bursa
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kayseri
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United Kingdom
State/province [91] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) - Study Design & Execution Collaborator
Address [1] 0 0
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Other
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Innovative Therapies For Children with Cancer Consortium
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Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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MD
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Amgen
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Contact person for public queries
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Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02303821