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NCT04872595 · ClinicalTrials.gov registry record · Phase 2
A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant
A Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT04872595: Active Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), sponsored by Memorial Sloan Kettering Cancer Center.
NCT04872595 is a Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 59 participants, below the 143-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04872595, a Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to see if conditioning regimens that include personalized rabbit ATG (P-rATG) help the immune system recover sooner and decrease the chances of transplant-related side effects. Participants in this study will be children and adults who have acute leukemia or myelodysplastic syndrome (MDS), and will receive a standard conditioning regimen to prepare the body for an allogeneic hematopoietic cell transplant (allo-HCT). The conditioning regimen will include r-ATG, one of two combinations of chemotherapy, and possibly total body irradiation (TBI).
Primary Outcome
is defined at CD4+ \> 50u/L at two consecutive measures within 100 days post allo-HCT.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Thiotepa
- OTHER Personalized rATG (P-rATG)
- RADIATION Hyper fractionated total body irradiation
- DRUG GCSF
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2021-04-30 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What the registry record for NCT04872595 still lists
NCT04872595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 143-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (59% lower).
The record links to 3 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04872595 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04872595 about?
NCT04872595 is a clinical study titled "A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant". The purpose of this study is to see if conditioning regimens that include personalized rabbit ATG (P-rATG) help the immune system recover sooner and decrease the chances of transplant-related side effects. Participants in this study will be children and adults who have acute leukemia or myelodysplas...
What is the current status of trial NCT04872595?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2021-04-30. Estimated completion is 2026-04.
What conditions does trial NCT04872595 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Acute Lymphoid Leukemia (ALL).
What interventions are being tested in trial NCT04872595?
The interventions under investigation include: Cyclophosphamide (DRUG), Thiotepa (DRUG), Personalized rATG (P-rATG) (OTHER), Hyper fractionated total body irradiation (RADIATION), GCSF (DRUG).
Who is sponsoring clinical trial NCT04872595?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04872595 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04872595's enrollment target sits among peer trials
59 19th of 29 higher than 11 of 29 other Acute Myeloid Leukemia (AML) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) 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.
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