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NCT03531736 · ClinicalTrials.gov registry record · Phase 1
T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia
A Phase 1 study of Myeloid Diseases, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 2
- Study locations
NCT03531736: Active Phase 1 study of Myeloid Diseases, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03531736 is a Phase 1 study of Myeloid Diseases that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03531736, a Phase 1 study of Myeloid Diseases, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 2
- Study locations
Study Summary
The main purpose of this study is to learn if a new combination of chemotherapy, in combination with low-dose radiation, will be safe for the patient, and at the same time provide the best opportunity to cure the bone marrow cancer. The combination of chemotherapy and radiation described in the study is considered 'low intensity.' Although the chemotherapy agents used in this study and for transplant are FDA approved, the chemotherapy treatment and conditioning regimens or combinations listed in this consent are not yet FDA approved. The CliniMACS device is FDA approved for one type of T cell depletion (positive selection of the stem cells) but not approved yet for other type of T cell depletion, which is being studied on this protocol. This pilot study, along with other studies will serve as the basis for FDA approval, if outcomes are favorable.
Primary Outcome
Neutrophil engraftment (recovery of ANC) defined by an ANC ≥ 500/mm\^3 for 3 consecutive days
Conditions Studied
Interventions
- DRUG fludarabine
- DRUG cyclophosphamide
- DRUG Antithymocyte globulin (Rabbit)
- RADIATION total body irradiation
- DRUG Rituxan
Study Locations (2)
New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
What the registry record for NCT03531736 still lists
NCT03531736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Myeloid Diseases appearing as the primary indexed condition, and to 5 interventions - of which fludarabine is the first listed.
NCT03531736 reports a single indexed study location in New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT03531736 about?
NCT03531736 is a clinical study titled "T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia". The main purpose of this study is to learn if a new combination of chemotherapy, in combination with low-dose radiation, will be safe for the patient, and at the same time provide the best opportunity to cure the bone marrow cancer. The combination of chemotherapy and radiation described in the stud...
What is the current status of trial NCT03531736?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2018-05-09. Estimated completion is 2026-05.
What conditions does trial NCT03531736 study?
This clinical trial studies the following conditions: Myeloid Diseases.
What interventions are being tested in trial NCT03531736?
The interventions under investigation include: fludarabine (DRUG), cyclophosphamide (DRUG), Antithymocyte globulin (Rabbit) (DRUG), total body irradiation (RADIATION), Rituxan (DRUG).
Who is sponsoring clinical trial NCT03531736?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03531736 being conducted?
This trial has 2 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03531736's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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