A Dose Escalation Study of Intensity Modulated Total Marrow Irradiation (IMRT-TMI) with Fludarabine as a Myeloablative Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation for Patients with Relapsed and Refractory Hematologic Malignancies

Overview

The purposes of this study are to: (1) find the most effective dose of a new type of radiation therapy called total marrow irradiation (TMI) that will be given with the conditioning chemotherapy, fludarabine, to prepare patients for allogeneic hematopoietic stem cell transplantation (Allo-HSCT); and (2) see if utilization of TMI in place of total body irradiation (TBI) will reduce side effects by giving less radiation to organs at risk.

Description

The purpose of this study is to find the most effective dose of a new type of radiation therapy called total marrow irradiation (TMI) that is given with a type of chemotherapy called fludarabine to prepare patients for allogeneic hematopoietic stem cell transplantation (Allo-HSCT).

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: acute myeloid leukemia,acute lymphocytic leukemia,myelodysplasia
  • Age: Between 18 Years - 65 Years
  • Gender: Male or Female

Inclusion Criteria
Patients must be diagnosed with one of the following conditions:
Acute Myeloid Leukemia (AML) who are not incomplete remission, and who have either primary refractory or relapsed disease
Acute Lymphocytic Leukemia (ALL) who are not in complete remission, and who have either primary refractory or relapsed disease
Myelodysplasia
Exclusion Criteria
Patients with ALL who are in second or subsequent relapse
Active infection: Patients with active infections requiring oral or intravenous antimicrobial drugs are not eligible for enrollment until resolution of infection.
HIV seropositive patients.
Pregnant or nursing females are excluded from this study.
Prior radiation therapy*Patients who have had a prior autologous or allogeneic bone marrow or stem cell transplantation


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022 . Study ID: TX9082

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