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NCT00481871 · ClinicalTrials.gov registry record · Phase 1
Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies
A Phase 1 study, sponsored by Acrotech Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 119
- Enrollment target
NCT00481871: Completed Phase 1 study, sponsored by Acrotech Biopharma.
NCT00481871 is a Phase 1 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 119 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00481871, a Phase 1 study, has completed, sponsored by Acrotech Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 119 participants
- Enrollment target
Study Summary
This study is for patients with lymphoproliferative malignancies that have progressed after receiving a previous treatment (relapsed) or are no longer responding to treatment (refractory). To be in this study, patients must have certain types of Hodgkin's lymphoma (HL), peripheral T-cell lymphoma (PTCL), or B-cell lymphoma, including Waldenstrom's macroglobulinemia. This study is being done to find doses of the combination of pralatrexate and gemcitabine with vitamin B12 and folic acid that can be safely given to patients with these types of lymphoma and explore the effectiveness of the treatment.
Primary Outcome
Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.
Interventions
- DRUG Gemcitabine Hydrochloride
- DIETARY_SUPPLEMENT Vitamin B12
- DRUG Pralatrexate Injection
- DIETARY_SUPPLEMENT Folic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2007-05 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT00481871 record still lists
NCT00481871 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 4 interventions - of which Gemcitabine Hydrochloride is the first listed.
NCT00481871 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00481871 about?
NCT00481871 is a clinical study titled "Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies". This study is for patients with lymphoproliferative malignancies that have progressed after receiving a previous treatment (relapsed) or are no longer responding to treatment (refractory). To be in this study, patients must have certain types of Hodgkin's lymphoma (HL), peripheral T-cell lymphoma (P...
What is the current status of trial NCT00481871?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2007-05. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00481871?
The interventions under investigation include: Gemcitabine Hydrochloride (DRUG), Vitamin B12 (DIETARY_SUPPLEMENT), Pralatrexate Injection (DRUG), Folic Acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00481871?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00481871's enrollment target sits among peer trials
119 498th of 2000 higher than 1,502 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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