Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00098839




Registration number
NCT00098839
Ethics application status
Date submitted
8/12/2004
Date registered
9/12/2004
Date last updated
12/12/2017

Titles & IDs
Public title
Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)
Scientific title
A Feasibility Pilot and Phase II Study Of Chemoimmunotherapy With Epratuzumab (IND #12034) for Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia (ALL)
Secondary ID [1] 0 0
NCI-2011-01624
Secondary ID [2] 0 0
ADVL04P2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Childhood Acute Lymphoblastic Leukemia 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
Treatment: Drugs - L-asparaginase
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - therapeutic hydrocortisone
Treatment: Drugs - vincristine sulfate
Treatment: Other - epratuzumab
Treatment: Drugs - cytarabine
Treatment: Drugs - prednisone
Treatment: Drugs - pegaspargase
Treatment: Drugs - dexrazoxane hydrochloride
Treatment: Drugs - methotrexate
Treatment: Drugs - etoposide
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - leucovorin calcium
Treatment: Other - filgrastim

Experimental: Reinduction Chemoimmunotherapy with Epratuzumab once weekly - Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

Experimental: Reinduction Chemoimmunotherapy with Epratuzumab twice weekly - Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 \& 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.


Treatment: Drugs: L-asparaginase
Given IM

Treatment: Drugs: doxorubicin hydrochloride
Given IV

Treatment: Drugs: therapeutic hydrocortisone
40 mg/m2/day PO divided BID or TID

Treatment: Drugs: vincristine sulfate
Given IV

Treatment: Other: epratuzumab
Given IV

Treatment: Drugs: cytarabine
Given IT

Treatment: Drugs: prednisone
Given orally

Treatment: Drugs: pegaspargase
Given IM

Treatment: Drugs: dexrazoxane hydrochloride
Given IV

Treatment: Drugs: methotrexate
Given IT

Treatment: Drugs: etoposide
Given IV

Treatment: Drugs: cyclophosphamide
Given IV

Treatment: Drugs: leucovorin calcium
Given IV

Treatment: Other: filgrastim
Given SC
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Remission Re-induction (CR2) Rate
Timepoint [1] 0 0
At the end of Block 1 of re-induction therapy (day 36)
Primary outcome [2] 0 0
Event-free Survival Rate
Timepoint [2] 0 0
At 4 months after enrollment
Primary outcome [3] 0 0
Rate of Minimal Residual Disease (MRD) < 0.01%
Timepoint [3] 0 0
At the end of Block 1 of re-induction therapy (day 36)
Secondary outcome [1] 0 0
Pharmacokinetics
Timepoint [1] 0 0
Up to day 36

Eligibility
Key inclusion criteria
* Diagnosis of B lymphoblastic leukemia (B-ALL)

* At least 25% expression of CD22 by immunophenotyping
* In marrow relapse (M3 bone marrow) with or without associated extramedullary disease as defined by 1 of the following:

* In first or later marrow relapse occurring any time after initial diagnosis (part A [closed to accrual as of 10/30/06] or B)
* In first, early marrow relapse with or without associated extramedullary disease occurring < 36 months from the time of initial diagnosis (part B only)
* No B-cell L3 morphology OR evidence of a regulator gene that codes for a transcription factor (MYC) translocation by molecular or cytogenetic analysis
* No Down syndrome
* Patients with CNS or other extramedullary site involvement are allowed
* Performance status - Karnofsky 50-100% (for patients > 10 years of age)
* Performance status - Lansky 50-100% (for patients = 10 years of age)
* White Blood Count (WBC) = 50,000/mm^3 (part A only [closed to accrual as of 10/30/06])
* Bilirubin = 1.5 times upper limit of normal unless disease-related (ULN)
* Alanine aminotransferase (ALT) = 5 times ULN
* Albumin = 2 g/dL
* Creatinine clearance OR radioisotope glomerular filtration rate = 70 mL/min
* Creatinine as defined by age as follows:

* = 0.5 mg/dL (for patients < 1 year old)
* = 0.8 mg/dL (for patients 1 to 5 years old)
* = 1.0 mg/dL (for patients 6 to 10 years old)
* = 1.2 mg/dL (for patients 11 to 15 years old)
* = 1.5 mg/dL (for patients > 15 years old)
* Shortening fraction = 27% by echocardiogram
* Ejection fraction = 45% by Multi Gated Acquisition Scan (MUGA)
* No dyspnea at rest
* No exercise intolerance
* Pulse oximetry > 94%
* No active or uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Recovered from prior immunotherapy
* At least 4 months since prior stem cell transplantation or rescue AND no evidence of active graft-vs-host disease
* At least 7 days since prior hematopoietic growth factors
* At least 7 days since prior biologic therapy*
* No other concurrent immunotherapy
* No other concurrent biologic therapy
* Recovered from prior chemotherapy

* No waiting period for children who relapse while receiving standard ALL maintenance therapy
* No prior cumulative anthracycline exposure > 400 mg/m^2*
* No concurrent chemotherapy
* Recovered from prior radiotherapy
* No concurrent radiotherapy
* At least 2 days since prior hydroxyurea
* No other concurrent investigational drugs
* No other concurrent anticancer agents
Minimum age
2 Years
Maximum age
31 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
134
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Mississippi
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Puerto Rico
State/province [30] 0 0
Santurce

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Elizabeth Raetz, MD
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 are available at https://clinicaltrials.gov/study/NCT00098839