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NCT00945815 · ClinicalTrials.gov registry record · Phase 2
S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
A Phase 2 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT00945815: Completed Phase 2 study, sponsored by SWOG Cancer Research Network.
NCT00945815 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00945815, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
RATIONALE: Monoclonal antibodies, such as epratuzumab, 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. Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving epratuzumab together with cytarabine and clofarabine may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumab together with cytarabine and clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia.
Primary Outcome
Complete remission (CR) is defined as: \<5% marrow aspirate blasts. Blasts can be \>=5% if the blasts are found to be myeloid and there is no evidence of lymphoblasts by flow cytometry or immunostaining. Neutrophils \>= 1000/mcl; platelets \>100,000/mcl; and no blasts in the peripheral blood. C1 Extramedullary disease status as defined in the protocol. Complete remission with incomplete platelet recovery (CRi) is same as CR but platelet count may be \<=100,000/mcl and/or ANC may be \<1,000/mcl.
Interventions
- OTHER laboratory biomarker analysis
- DRUG clofarabine
- DRUG cytarabine
- BIOLOGICAL epratuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-09 |
| Est. Completion | 2017-08 |
| Phase | Phase 2 |
What the finished NCT00945815 record still lists
NCT00945815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00945815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00945815 about?
NCT00945815 is a clinical study titled "S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia". RATIONALE: Monoclonal antibodies, such as epratuzumab, 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. Drugs used in chemotherapy, such as cytarabine and clof...
What is the current status of trial NCT00945815?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2010-09. Estimated completion is 2017-08.
What interventions are being tested in trial NCT00945815?
The interventions under investigation include: laboratory biomarker analysis (OTHER), clofarabine (DRUG), cytarabine (DRUG), epratuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00945815?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00945815's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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