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NCT00998946 · ClinicalTrials.gov registry record · Phase 2
Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
A Phase 2 study, sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT00998946: Completed Phase 2 study, sponsored by Spectrum Pharmaceuticals.
NCT00998946 is a Phase 2 study that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00998946, a Phase 2 study, has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this participant population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this participant population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).
Primary Outcome
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR). Tumor response was evaluated on the basis of clinical and radiological criteria, assessed according to International Workshop Criteria (IWC) with or without positron emission tomography (PET) scans. Per IWC criteria CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if
Interventions
- DIETARY_SUPPLEMENT Vitamin B12
- DRUG Pralatrexate
- DIETARY_SUPPLEMENT Folic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT00998946 record still lists
NCT00998946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Vitamin B12 is the first listed.
NCT00998946 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00998946 about?
NCT00998946 is a clinical study titled "Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma". The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this parti...
What is the current status of trial NCT00998946?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2009-09. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00998946?
The interventions under investigation include: Vitamin B12 (DIETARY_SUPPLEMENT), Pralatrexate (DRUG), Folic Acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00998946?
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 NCT00998946's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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