Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00612612 · ClinicalTrials.gov registry record · Phase 1
Obatoclax, Fludarabine, and Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00612612: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00612612 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00612612, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Obatoclax may stop the growth of chronic lymphocytic leukemia by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving obatoclax together with fludarabine and rituximab may kill more cancer cells. This phase I trial is studying the side effects and best dose of obatoclax when given together with fludarabine and rituximab in treating patients with B-cell chronic lymphocytic leukemia.
Primary Outcome
DLT will be defined as any non-hematologic toxicity of grade 3 or greater severity (excluding asymptomatic grade 3 laboratory abnormalities that are not life-threatening and respond to treatment; grade 3 fatigue; grade 3 nausea, vomiting or diarrhea occurring without optimal prophylaxis; or expected grade 3 rituximab infusion reactions). Any grade 4 non-hematological toxicity, as well as any irreversible grade 2 cardiac, renal or neurologic toxicities, will be considered dose-limiting. Grading o
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL rituximab
- DRUG fludarabine phosphate
- DRUG obatoclax mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2008-01 |
| Phase | Phase 1 |
Why NCT00612612 stopped before completion
NCT00612612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00612612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00612612 about?
NCT00612612 is a clinical study titled "Obatoclax, Fludarabine, and Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia". Obatoclax may stop the growth of chronic lymphocytic leukemia by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by...
What is the current status of trial NCT00612612?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2008-01.
What interventions are being tested in trial NCT00612612?
The interventions under investigation include: laboratory biomarker analysis (OTHER), rituximab (BIOLOGICAL), fludarabine phosphate (DRUG), obatoclax mesylate (DRUG).
Who is sponsoring clinical trial NCT00612612?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00612612's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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
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
- NCT03471117 · 28 participants · Phase 4
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
- NCT03523975 · 28 participants · Phase 1
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
- NCT03608631 · 28 participants · Phase 1
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
- NCT03810651 · 28 participants · Early Phase 1
Pencil Beam Scanning in Patients With Renal Tumors
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