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NCT01664910 · ClinicalTrials.gov registry record · Phase 1
CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01664910: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01664910 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01664910, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and the best dose of inotuzumab ozogamicin when given together with fludarabine phosphate, bendamustine hydrochloride, and rituximab before donor stem cell transplant in treating patients with lymphoid malignancies. Giving chemotherapy drugs, such as fludarabine phosphate and bendamustine hydrochloride, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells or abnormal cell and helps stop the patient's immune system from rejecting the donor's stem cells. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin and rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cell from a donor can make an immune system response against the body's normal cells. Giving fludarabine phosphate and bendamustine hydrochloride before the transplant together with anti-thymocyte globulin and tacrolimus may stop this from happening.
Primary Outcome
Number of participants received inotuzumab in each cohort without DLT
Interventions
- BIOLOGICAL Anti-Thymocyte Globulin
- DRUG Fludarabine Phosphate
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- DRUG Bendamustine Hydrochloride
- PROCEDURE Allogeneic Bone Marrow Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2012-10-29 |
| Est. Completion | 2023-06-28 |
| Phase | Phase 1 |
What the finished NCT01664910 record still lists
NCT01664910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which Anti-Thymocyte Globulin is the first listed.
NCT01664910 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01664910 about?
NCT01664910 is a clinical study titled "CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies". This phase I/II trial studies the side effects and the best dose of inotuzumab ozogamicin when given together with fludarabine phosphate, bendamustine hydrochloride, and rituximab before donor stem cell transplant in treating patients with lymphoid malignancies. Giving chemotherapy drugs, such as fl...
What is the current status of trial NCT01664910?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2012-10-29. Estimated completion is 2023-06-28.
What interventions are being tested in trial NCT01664910?
The interventions under investigation include: Anti-Thymocyte Globulin (BIOLOGICAL), Fludarabine Phosphate (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Bendamustine Hydrochloride (DRUG), Allogeneic Bone Marrow Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01664910?
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 NCT01664910's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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
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