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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01420679




Registration number
NCT01420679
Ethics application status
Date submitted
18/08/2011
Date registered
22/08/2011
Date last updated
19/11/2021

Titles & IDs
Public title
Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients
Scientific title
A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients Previously Undiagnosed Peripheral T-cell Lymphoma Who Achieved an Objective Response After Initial Treatment With CHOP-based Chemotherapy
Secondary ID [1] 0 0
2010-022230-81
Secondary ID [2] 0 0
PDX-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral T-cell Lymphoma 0 0
Condition category
Condition code
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 - Pralatrexate Injection

Experimental: Pralatrexate - Patients randomized to the Pralatrexate Arm will receive pralatrexate injection and Vitamins B12 and Folic Acid until a criterion for pralatrexate injection treatment discontinuation is met.

No intervention: Observation - Patients randomized to the Observation Arm will receive Vitamins B12 and Folic Acid and remain under observation until a criterion for observation discontinuation is met.


Treatment: Drugs: Pralatrexate Injection
Intravenous (IV) push administration over 30 seconds to 5 minutes via a patent IV line containing normal saline (0.9% sodium chloride).

Initial dose: 30 mg/m2

Administered weekly for 3 weeks of a 4-week cycle until criteria for discontinuation per the protocol are met.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
From randomization to the date of progression of disease or death due to any cause (up to 76 months)
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomization until death (up to 76 months)
Secondary outcome [1] 0 0
Objective Response Rate
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities
Timepoint [2] 0 0
From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years)

Eligibility
Key inclusion criteria
* Patient has one of the following peripheral T-cell lymphoma (PTCL) subtypes confirmed by an independent central pathology reviewer, using the Revised European American Lymphoma World Health Organization disease classification:

* T/natural killer (NK)-cell leukemia/lymphoma
* Adult T-cell lymphoma (TCL)/leukemia (human T-cell leukemia virus 1+)
* Angioimmunoblastic TCL
* Anaplastic large cell lymphoma (ALCL), primary systemic type, excluding anaplastic lymphoma kinase positive (ALK+) with International Prognostic Index (IPI) score less than 2 at initial diagnosis and complete response (CR) after CHOP-based therapy
* PTCL-unspecified
* Enteropathy-type intestinal lymphoma
* Hepatosplenic TCL
* Subcutaneous panniculitis TCL
* Transformed mycosis fungoides (tMF)
* Extranodal T/NK-cell lymphoma nasal or nasal type
* Primary cutaneous gamma-delta TCL
* Primary cutaneous CD8+ aggressive epidermic cytotoxic TCL
* Documented completion of at least 6 cycles of CHOP-based therapy:

* CHOP 21
* CHOP 14
* CHOP + etoposide
* Other CHOP variants: substitution allowed for 1 component with a drug of the same mechanism of action. Additional components, except alemtuzumab, are allowed. Rituximab may be added if not given within 3 cycles of randomization.
* Patient has achieved CR or partial response (PR) per per investigator's assessment following completion of CHOP-based therapy and has had radiological assessment within 21 days prior to randomization.
* Eastern Cooperative Oncology Group performance status less than or equal to 2.
* Adequate blood, liver, and kidney function as defined by laboratory tests.
* Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate.
* Men who are sexually active, including those with a pregnant partner, must agree to practice a medically acceptable barrier method contraceptive regimen (eg, condoms) while receiving pralatrexate and for 90 days after the last administration of pralatrexate.
* Has given written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient has:

* Precursor T/NK neoplasms
* ALCL (ALK+) with IPI score less than 2 at initial diagnosis and CR after CHOP-based therapy
* T cell prolymphocytic leukemia
* T cell large granular lymphocytic leukemia
* Mycosis fungoides, except tMF
* Sézary syndrome
* Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis
* If there is a history of prior malignancies other than those below, must be disease free for at least 5 years. Patients with malignancies listed below less than 5 years before study entry may be enrolled if they have received treatment resulting in complete resolution of the cancer and have no clinical, radiologic, or laboratory evidence of active/recurrent disease.

* non-melanoma skin cancer
* carcinoma in situ of the cervix
* localized prostate cancer
* localized thyroid cancer
* Receipt of prior chemotherapy (CT) or radiation therapy (RT) for PTCL, other than a single allowed CHOP regimen, except:

* Patients with nasal NK lymphoma who received local RT less than 4 weeks prior to randomization.
* Patients with tMF who received 1 systemic single-agent CT (except methotrexate) prior to transformation.
* Prior exposure to pralatrexate.
* Receipt of systemic corticosteroids within 3 weeks of study treatment, unless patient has been taking a continuous dose of 10 mg/day or less of oral prednisone or equivalent for at least 4 weeks or as part of a CHOP prednisone taper.
* Planned use of any treatment for PTCL during the course of the study.
* Patient has:

* Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of less than 100 mm3 or detectable viral load within past 3 months and receiving anti-retroviral therapy.
* Hepatitis B (HBV)-positive serology and is receiving interferon therapy or has liver function test results outside the parameters of study inclusion criteria. Other antiviral therapies are permitted if at a stable dose for at least 4 weeks.
* Hepatitis C (HCV) virus with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy.
* Symptomatic central nervous system metastases or lesions requiring treatment.
* Uncontrolled hypertension or congestive heart failure Class III/IV per the New York Heart Association's Heart Failure Guidelines
* Active uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness impairing the ability of the patient to receive protocol treatment.
* Major surgery within 2 weeks prior to study entry, except for line placement or biopsy procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Center - Bedford Park
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
Saint Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Frankston Hospital - Frankston
Recruitment hospital [7] 0 0
Cabrini Health - Malvern
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
7001 - Hobart
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3109 - Fitzroy
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Belgium
State/province [3] 0 0
Brugge
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
France
State/province [7] 0 0
Brest
Country [8] 0 0
France
State/province [8] 0 0
Pessac
Country [9] 0 0
Ireland
State/province [9] 0 0
Dublin 8
Country [10] 0 0
Israel
State/province [10] 0 0
Jerusalem
Country [11] 0 0
Israel
State/province [11] 0 0
Petach Tikva
Country [12] 0 0
Israel
State/province [12] 0 0
Tel Hashomer
Country [13] 0 0
Italy
State/province [13] 0 0
Forli
Country [14] 0 0
Italy
State/province [14] 0 0
Bologna
Country [15] 0 0
Italy
State/province [15] 0 0
Brescia
Country [16] 0 0
Italy
State/province [16] 0 0
Ravenna
Country [17] 0 0
Italy
State/province [17] 0 0
Roma
Country [18] 0 0
Italy
State/province [18] 0 0
Siena
Country [19] 0 0
New Zealand
State/province [19] 0 0
Auckland
Country [20] 0 0
New Zealand
State/province [20] 0 0
Christchurch
Country [21] 0 0
New Zealand
State/province [21] 0 0
Milford
Country [22] 0 0
Poland
State/province [22] 0 0
Mazowieckie
Country [23] 0 0
Poland
State/province [23] 0 0
Gdansk
Country [24] 0 0
Poland
State/province [24] 0 0
Kraków
Country [25] 0 0
Puerto Rico
State/province [25] 0 0
San Juan
Country [26] 0 0
Spain
State/province [26] 0 0
Navarra
Country [27] 0 0
Spain
State/province [27] 0 0
A Coruña
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Cornwall
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Dorset
Country [32] 0 0
United Kingdom
State/province [32] 0 0
England
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Northern Ireland
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Scotland
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Belfast
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Cardiff
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Liverpool
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Middlesex
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Warwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Spectrum Pharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01420679