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NCT01253460 · ClinicalTrials.gov registry record · Phase 2
Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01253460: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01253460 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01253460, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if sapacitabine given in combination with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The safety of this drug combination will also be studied.
Primary Outcome
Patients evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] overall response criteria before course 4, then after every 2 courses, and at end of treatment (2 months after last course). Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR). Complete response is the absence of signs and symptoms, normalization of peripheral blood and bone marrow and lymph nodes 1.5 cm in diameter or smaller on CT scan. Partial response is at least
Interventions
- DRUG Cyclophosphamide
- DRUG Rituximab
- DRUG Sapacitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-08-22 |
| Est. Completion | 2019-02-13 |
| Phase | Phase 2 |
Why NCT01253460 stopped before completion
NCT01253460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01253460 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01253460 about?
NCT01253460 is a clinical study titled "Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)". The goal of this clinical research study is to learn if sapacitabine given in combination with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The safety of this drug combination will also be studied.
What is the current status of trial NCT01253460?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2011-08-22. Estimated completion is 2019-02-13.
What interventions are being tested in trial NCT01253460?
The interventions under investigation include: Cyclophosphamide (DRUG), Rituximab (DRUG), Sapacitabine (DRUG).
Who is sponsoring clinical trial NCT01253460?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01253460's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 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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