Study of Pralatrexate Versus Observation Following CHOP-based Chemotherapy in Previously Undiagnosed Peripheral T-cell Lymphoma Patients
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|ClinicalTrials.gov Identifier: NCT01420679|
Recruitment Status : Terminated
First Posted : August 22, 2011
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral T-cell Lymphoma||Drug: Pralatrexate Injection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients With Previously Undiagnosed Peripheral T-cell Lymphoma Who Have Achieved an Objective Response Following Initial Treatment With CHOP-based Chemotherapy|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
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.
Drug: 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.
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.
- Progression-free Survival (PFS) [ Time Frame: Assessed at 8 weeks (+/-1 wk) then every 12 weeks (+/-1 wk) through 3 years, then every 24 weeks (+/-4 wks) until progression of disease (PD) or up to 7 years post-randomization ]
- Overall Survival (OS) [ Time Frame: Collected approximately every 6 months after documented PD through 7 years post-randomization ]
- Objective Response to Pralatrexate versus Observation [ Time Frame: Assessed at 8 weeks (+/-1 wk) then every 12 weeks (+/-1 wk) through 3 years, then every 24 weeks (+/-4 wks) until progression of disease (PD) or up to 7 years post-randomization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420679
Show 55 Study Locations
|Study Director:||Pankaj Sharma, MD||Spectrum Pharmaceuticals, Inc|