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NCT06128070 · ClinicalTrials.gov registry record · Phase 2
Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06128070: Recruiting Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.
NCT06128070 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 40 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06128070, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests how well ruxolitinib with tacrolimus and methotrexate work to prevent the development of graft versus host disease in pediatric and young adult patients undergoing allogeneic hematopoietic cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Ruxolitinib is a type of medication called a kinase inhibitor. It works by blocking the signals of cells that cause inflammation and cell proliferation, which may help prevent graft versus host disease (GVHD). Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants by suppressing the immune system. Methotrexate stops cells from making DNA, may kill cancer cells, and also suppress the immune system, which may reduce the risk of GVHD. Giving ruxolitinib with tacrolimus and methotrexate may prevent GVHD in pediatric and young adults undergoing allogeneic hematopoietic cell transplants.
Primary Outcome
Defined using the modified Bearman Scale and the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 scale.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Chest Computed Tomography
- PROCEDURE Echocardiography
- DRUG Methotrexate
- PROCEDURE Hematopoietic Cell Transplantation
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-07-16 |
| Est. Completion | 2030-11-22 |
| Phase | Phase 2 |
What NCT06128070 shows while recruiting
NCT06128070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (66% lower).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06128070 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06128070 about?
NCT06128070 is a clinical study titled "Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome". This phase II trial tests how well ruxolitinib with tacrolimus and methotrexate work to prevent the development of graft versus host disease in pediatric and young adult patients undergoing allogeneic hematopoietic cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodys...
What is the current status of trial NCT06128070?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-07-16. Estimated completion is 2030-11-22.
What conditions does trial NCT06128070 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT06128070?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Chest Computed Tomography (PROCEDURE), Echocardiography (PROCEDURE), Methotrexate (DRUG), Hematopoietic Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT06128070?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06128070 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06128070's enrollment target sits among peer trials
40 170th of 306 higher than 128 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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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