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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 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. The trial reports 2 study locations across 2 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03531736
The ClinicalTrials.gov registry entry for NCT03531736 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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