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Recruiting Phase 2 NCT05031897

Two Step Haplo With Radiation Conditioning

Trial Parameters

Condition Acute Lymphoblastic Leukemia
Sponsor Thomas Jefferson University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 63
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-10-25
Completion 2032-04
Interventions
FludarabineTotal-Body IrradiationDonor Lymphocyte Infusion

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Radiation-based cohort diagnoses: * Acute myeloid leukemia * Acute lymphoid leukemia in remission * Myelodysplasia (MDS) * Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement * Multiple myeloma * Chronic myeloid leukemia * Myelofibrosis * Myeloid malignancy not otherwise specified * Chronic myelomonocytic leukemia * Essential thrombocytopenia or polycythemia vera * T cell leukemia * T cell lymphoma without significant lymph node disease burden * Any hematological malignancy or dyscrasia not cited above in which HSCT is potentially curable * Any patient who has a hematological disease that would normally be treated on a myeloablative study, but is prevented from doing so by factors in their past medical history. Examples are patients with previous treatment with radiation therapy precluding total-body irradiation (TBI), or a past history of myeloablative therapy, precluding a 2nd myeloablative regimen. * Patients must have a donor who is on

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