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NCT01352312 · ClinicalTrials.gov registry record · Phase 1
Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01352312: Clinical Trial Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT01352312 is a Phase 1 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01352312, a Phase 1 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a Phase 1 study with Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab (PBO) for patients with previously treated Chronic Lymphocytic Leukemia (CLL) and B-cell Non-Hodgkin's Lymphoma (B- cell NHL). The purpose of this study is to determine the optimal dose of bendamustine in combination with pentostatin and ofatumumab, and then to see how safe these three drugs work together.
Primary Outcome
The primary objective of this study is to determine the dose of bendamustine in combination with pentostatin and ofatumumab at which \<33% of patients with relapsed Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) experience severe toxicity; and to assess the toxicity of this regimen.
Interventions
- DRUG Bendamustine
- DRUG Ofatumumab
- DRUG Pentostatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-05-25 |
| Est. Completion | 2018-05-10 |
| Phase | Phase 1 |
Why NCT01352312 stopped before completion
NCT01352312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Bendamustine is the first listed.
NCT01352312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01352312 about?
NCT01352312 is a clinical study titled "Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma". This is a Phase 1 study with Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab (PBO) for patients with previously treated Chronic Lymphocytic Leukemia (CLL) and B-cell Non-Hodgkin's Lymphoma (B- cell NHL). The purpose of this study is to determine the optimal dose of bendamustine in combi...
What is the current status of trial NCT01352312?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2011-05-25. Estimated completion is 2018-05-10.
What interventions are being tested in trial NCT01352312?
The interventions under investigation include: Bendamustine (DRUG), Ofatumumab (DRUG), Pentostatin (DRUG).
Who is sponsoring clinical trial NCT01352312?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01352312's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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