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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2010-022230-81
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Secondary ID [2]
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PDX-017
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral T-cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS was defined as the time in days from randomization to the date of objective documentation of progressive disease (PD) or death, regardless of cause (date of PD or death - date of randomization + 1). PFS was to be assessed according to the International Workshop Criteria (IWC) without including positron emission tomography (PET). PD was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir. Participants who were alive without a disease response assessment of PD was to be censored at their last disease assessment date or the date of randomization, whichever was later. Date of progression was not to be imputed for participants with missing tumor assessments before an assessment of PD. Participants who withdraw from treatment prior to PD were to be followed for disease status whenever possible. Participants who have no response assessments after baseline were to be censored at randomization.
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Timepoint [1]
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From randomization to the date of progression of disease or death due to any cause (up to 76 months)
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall survival was defined as the time in days from randomization to the date of death, regardless of cause (date of death - date of randomization + 1).
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Timepoint [2]
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From randomization until death (up to 76 months)
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Secondary outcome [1]
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Objective Response Rate
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Assessment method [1]
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Objective response rate was defined as percentage of participants with an objective response of complete response (CR) or partial response (PR), relative to disease status at the time of study entry. The percentage was to be calculated by dividing number of participants within each category of response by the number of participants with measurable disease at baseline. Objective response was assessed according to the IWC without including PET. CR was defined as complete disappearance all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR was defined as regression of measurable disease and no new sites.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [2]
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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
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Assessment method [2]
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An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. AE included both serious and non- SAEs. An AE of "Hematology and Chemistry" was collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening and Grade 4 refers to life-threatening consequences.
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Timepoint [2]
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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)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2017
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Sample size
Target
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Accrual to date
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Final
21
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Recruitment in Australia
Recruitment state(s)
SA,TAS,VIC,WA
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Flinders Medical Center - Bedford Park
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Royal Hobart Hospital - Hobart
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Monash Medical Centre - Clayton
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Saint Vincent's Hospital Melbourne - Fitzroy
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Frankston Hospital - Frankston
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Cabrini Health - Malvern
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Recruitment hospital [8]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment postcode(s) [3]
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7001 - Hobart
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3109 - Fitzroy
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Recruitment postcode(s) [6]
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3199 - Frankston
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Recruitment postcode(s) [7]
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3144 - Malvern
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Recruitment postcode(s) [8]
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6000 - Perth
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Recruitment outside Australia
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United States of America
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Michigan
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Gent
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Ontario
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France
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Pessac
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Dublin 8
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Israel
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Middlesex
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United Kingdom
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Warwick
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Spectrum Pharmaceuticals, Inc
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to see if pralatrexate extends response and survival following
CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone)
and if pralatrexate improves response in patients with partial response following CHOP-based
chemotherapy. Patients will either receive pralatrexate or be under observation. All patients
will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their
disease and health.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01420679
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01420679
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