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NCT01134575 · ClinicalTrials.gov registry record · Phase 2
CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT01134575: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01134575 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01134575, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if CMC-544 given alone, and possibly given in combination with rituximab, can help to control the disease in patients with ALL. The safety of the study drug(s) will also be studied.
Primary Outcome
Primary endpoint for efficacy is response which is defined as: Complete Remission (CR), Complete Remission without recovery of counts (CRi) or Partial Remission (PR). Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x109/L, platelet count \>100x109/L, and normal marrow differential (\< 5% blasts). 8.2 Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover
Interventions
- DRUG Rituximab
- DRUG CMC-544 (Inotuzumab Ozogamycin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2010-06-04 |
| Est. Completion | 2018-04-18 |
| Phase | Phase 2 |
What the finished NCT01134575 record still lists
NCT01134575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT01134575 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01134575 about?
NCT01134575 is a clinical study titled "CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)". The goal of this clinical research study is to learn if CMC-544 given alone, and possibly given in combination with rituximab, can help to control the disease in patients with ALL. The safety of the study drug(s) will also be studied.
What is the current status of trial NCT01134575?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2010-06-04. Estimated completion is 2018-04-18.
What interventions are being tested in trial NCT01134575?
The interventions under investigation include: Rituximab (DRUG), CMC-544 (Inotuzumab Ozogamycin) (DRUG).
Who is sponsoring clinical trial NCT01134575?
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 NCT01134575's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 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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