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NCT01013961 · ClinicalTrials.gov registry record · Phase 2
Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic Leukemia
A Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
- Terminated
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01013961: Clinical Trial Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
NCT01013961 is a Phase 2 study that was terminated before completion, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01013961, a Phase 2 study, was terminated before completion, sponsored by ECOG-ACRIN Cancer Research Group.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, 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 rituximab together with alemtuzumab may kill more cancer cells. PURPOSE: This randomized phase II trial is studying two different doses of rituximab to compare how well they work when given together with alemtuzumab in treating older patients with progressive chronic lymphocytic leukemia.
Primary Outcome
Response was evaluated using NCI-WG96 criteria. A CR requires all of the following for \>= 2 months: * Absence of lymphadenopathy \> 1 cm in diameter by physical examination * No hepatomegaly or splenomegaly on physical exam * No constitutional symptoms * Normal complete blood count (CBC) * Patients achieving a clinical CR with negative CT scan after 2 cycles of therapy are re-evaluated using immunohistochemical examination of bone marrow biopsy for residual CLL cells. Patients with no evidenc
Interventions
- BIOLOGICAL rituximab
- BIOLOGICAL alemtuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-04-27 |
| Est. Completion | 2015-04-14 |
| Phase | Phase 2 |
Why NCT01013961 stopped before completion
NCT01013961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which rituximab is the first listed.
NCT01013961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01013961 about?
NCT01013961 is a clinical study titled "Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic Leukemia". RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, 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 rituximab together with alemtuzuma...
What is the current status of trial NCT01013961?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2011-04-27. Estimated completion is 2015-04-14.
What interventions are being tested in trial NCT01013961?
The interventions under investigation include: rituximab (BIOLOGICAL), alemtuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01013961?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01013961's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 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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