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NCT05031897 · ClinicalTrials.gov registry record · Phase 2
Two Step Haplo With Radiation Conditioning
A Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT05031897: Recruiting Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, sponsored by Thomas Jefferson University.
NCT05031897 is a Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 63 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05031897, a Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.
Primary Outcome
TRM is defined as death without evidence of recurrent disease in the 2 year period post HSCT. Summarized using Kaplan-Meier curves and the respective Kaplan-Meier estimates of the 2-year event rate are reported as well as their 95% confidence intervals.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- RADIATION Total-Body Irradiation
- DRUG Tacrolimus
- PROCEDURE Donor Lymphocyte Infusion
Study Locations (1)
Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadephia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2032-04 |
| Phase | Phase 2 |
What NCT05031897 shows while recruiting
NCT05031897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (46% lower).
The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05031897 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05031897 about?
NCT05031897 is a clinical study titled "Two Step Haplo With Radiation Conditioning". This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however thi...
What is the current status of trial NCT05031897?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2021-10-25. Estimated completion is 2032-04.
What conditions does trial NCT05031897 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelomonocytic Leukemia, Hodgkin Lymphoma.
What interventions are being tested in trial NCT05031897?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Total-Body Irradiation (RADIATION), Tacrolimus (DRUG), Donor Lymphocyte Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT05031897?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05031897 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05031897's enrollment target sits among peer trials
63 116th of 306 higher than 190 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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