Two Step Haplo With Radiation Conditioning

Recruiting now · Phase 2

Conditions studied: 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, Hematopoietic and Lymphatic System Neoplasm, Hodgkin Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome, Myelofibrosis, Myeloid Neoplasm, Non-Hodgkin Lymphoma, Polycythemia Vera, Small Lymphocytic Lymphoma

In brief

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.

Key facts

Study ID

NCT05031897

Run by

Thomas Jefferson University

People needed

63

Starts

2021-10-25

Expected to finish

2032-04-01

Last updated by the study team

2025-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 one-haplotype mismatched (number of mismatches in either direction not considered)
• Chemotherapy-based cohort diagnoses:
• Hodgkin or non-Hodgkin lymphoma
• Small lymphocytic lymphoma/CLL
• Any other diagnosis in which chemotherapy is thought to be superior to radiotherapy for treatment of the disease
• Hematological malignancy in patients who cannot receive > 2 Gy radiation
• Aplastic anemia and other non-malignant hematologic dyscrasias
• Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)
• Human leukocyte antigen (HLA) identical cohort diagnoses:
• Patients in this group will be treated in parallel to the radiation-based cohort or the chemotherapy-based group based on what category their diagnosis falls into. However, these patients will have HLA identical related donors (one-antigen cross-over event included).

Where it is running

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadephia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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