Clinical Trial

Two Step Haplo With Radiation Conditioning

Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2021-08-31; most recent amendment 2025-10-28.
Status change: Suspended → Recruiting 2025-10-28
Status change: Recruiting → Suspended 2025-08-05
Status change: Not Yet Recruiting → Recruiting 2021-11-02
Trial Details
NCT Number NCT05031897
Lead Sponsor Thomas Jefferson University
Conditions Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Adult T-Cell Leukemia/Lymphoma, Aplastic Anemia, Chronic Lymphocytic Leukemia, Chronic Myeloid Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, Essential Thrombocythemia +9 more
Enrollment 63 participants
Start Date 2021-10-25
Primary Completion 2032-04 (estimated)
Study Completion 2032-04 (estimated)
Updated on ClinicalTrials.gov 2025-10-30