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NCT01535924 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma
A Phase 1 study, sponsored by Beth Christian.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01535924: Completed Phase 1 study, sponsored by Beth Christian.
NCT01535924 is a Phase 1 study that has completed, run by Beth Christian. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01535924, a Phase 1 study, has completed, sponsored by Beth Christian.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride when given together with gemcitabine hydrochloride and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells.
Primary Outcome
Dose limiting toxicity will be defined during cycle 1 only of the phase I trial. Hematologic and Infectious Dose Limiting Toxicities include: Grade 3 febrile neutropenia persisting\> 7 days, Grade 4 infection or febrile neutropenia. Treatment delay\>14 days due to grade 3-4 neutropenia or thrombocytopenia. Non-Hematological Dose Limiting Toxicities include: any Grade 3 or 4 non-hematologic toxicity related to study treatment with the exception of nausea or vomiting, alopecia, or electrolyte/gluc
Interventions
- DRUG bendamustine hydrochloride
- DRUG gemcitabine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2012-02-09 |
| Est. Completion | 2019-02-20 |
| Phase | Phase 1 |
What the finished NCT01535924 record still lists
NCT01535924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which bendamustine hydrochloride is the first listed.
NCT01535924 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01535924 about?
NCT01535924 is a clinical study titled "Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma". This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride when given together with gemcitabine hydrochloride and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride ...
What is the current status of trial NCT01535924?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2012-02-09. Estimated completion is 2019-02-20.
What interventions are being tested in trial NCT01535924?
The interventions under investigation include: bendamustine hydrochloride (DRUG), gemcitabine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01535924?
This trial is sponsored by Beth Christian, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01535924's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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