Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01420679 · ClinicalTrials.gov registry record · Phase 3
Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients
A Phase 3 study, sponsored by Spectrum Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 21
- Enrollment target
NCT01420679: Clinical Trial Phase 3 study, sponsored by Spectrum Pharmaceuticals.
NCT01420679 is a Phase 3 study that was terminated before completion, run by Spectrum Pharmaceuticals. The registered enrollment target is 21 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01420679, a Phase 3 study, was terminated before completion, sponsored by Spectrum Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 21 participants
- Enrollment target
Study 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.
Primary Outcome
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 wi
Interventions
- DRUG Pralatrexate Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-08 |
| Est. Completion | 2017-12 |
| Phase | Phase 3 |
Why NCT01420679 stopped before completion
NCT01420679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Pralatrexate Injection is the first listed.
NCT01420679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01420679 about?
NCT01420679 is a clinical study titled "Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients". 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 w...
What is the current status of trial NCT01420679?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 21 participants. The study started on 2011-08. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01420679?
The interventions under investigation include: Pralatrexate Injection (DRUG).
Who is sponsoring clinical trial NCT01420679?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01420679's enrollment target sits among peer trials
21 1953rd of 2000 higher than 45 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02447874 · 21 participants · Phase 1
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
- NCT03826992 · 21 participants · Phase 1
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
- NCT04107077 · 21 participants · Phase 2
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
- NCT04158635 · 21 participants · Phase 1
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia