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NCT02333162 · ClinicalTrials.gov registry record · Phase 1
Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant
A Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Previously Treated Myelodysplastic Syndrome, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT02333162 is a Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Previously Treated Myelodysplastic Syndrome that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 30 participants, below the 53-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02333162, a Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Previously Treated Myelodysplastic Syndrome, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and the best dose of intensity modulated total marrow irradiation (IMTMI) when given together with fludarabine phosphate and melphalan in treating patients with cancers of the blood (hematologic) that have returned after a period of improvement (relapsed) undergoing a second donor stem cell transplant. IMTMI is a type of radiation therapy to the bone marrow that may be less toxic and may also reduce the chances of cancer to return. Giving fludarabine phosphate, melphalan, and IMTMI before a donor stem cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. 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.
Conditions Studied
Interventions
- DRUG Melphalan
- RADIATION Intensity-Modulated Radiation Therapy
- DRUG Fludarabine Phosphate
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- RADIATION Total Marrow Irradiation
Study Locations (1)
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-12-05 |
| Est. Completion | 2028-12-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02333162
The ClinicalTrials.gov registry entry for NCT02333162 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 53-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target (43% lower). The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Recurrent Adult Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Melphalan is the first listed.
NCT02333162 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT02333162 about?
NCT02333162 is a clinical study titled "Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant". This phase I trial studies the side effects and the best dose of intensity modulated total marrow irradiation (IMTMI) when given together with fludarabine phosphate and melphalan in treating patients with cancers of the blood (hematologic) that have returned after a period of improvement (relapsed) ...
What is the current status of trial NCT02333162?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-12-05. Estimated completion is 2028-12-01.
What conditions does trial NCT02333162 study?
This clinical trial studies the following conditions: Recurrent Adult Acute Myeloid Leukemia, Previously Treated Myelodysplastic Syndrome, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Hematologic Malignancy.
What interventions are being tested in trial NCT02333162?
The interventions under investigation include: Melphalan (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Fludarabine Phosphate (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Total Marrow Irradiation (RADIATION).
Who is sponsoring clinical trial NCT02333162?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02333162 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Recurrent Adult Acute Myeloid Leukemia
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Previously Treated Myelodysplastic Syndrome
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