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

Investigating Total Marrow Irradiation for Stem Cell Transplant Preparation

Recruiting
18 years - 65 years
All
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

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).
Participants will not be paid for their participation.

Eligibility of study

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

  • Conditions: myelodysplasia,acute myeloid leukemia,acute lymphocytic leukemia
  • Age: 18 years - 65 years
  • Gender: All

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

Updated on 19 Feb 2024. Study ID: 1803628152 (IUSCC-0652)

This study investigates a new type of radiation therapy called total marrow irradiation (TMI) for patients undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT). It aims to find the most effective dose of TMI when used with a chemotherapy drug called fludarabine. This combination is used to prepare patients for the transplant.

Participants in this study will receive TMI instead of the traditional total body irradiation (TBI). The study will assess whether TMI can reduce side effects by delivering less radiation to vulnerable organs. Participants will not be compensated for their involvement.

  • Who can participate: Patients with Acute Myeloid Leukemia (AML) or Acute Lymphocytic Leukemia (ALL) not in complete remission, or with Myelodysplasia, may participate. Exclusion criteria include active infections, HIV positivity, pregnancy, previous radiation therapy, or stem cell transplantation.
  • Study details: Participants will receive total marrow irradiation (TMI) along with chemotherapy to prepare for stem cell transplantation. A placebo is not used in this study.

Find a site

Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact label
Race
Ethnicity
Other language

Default Content Message Here