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

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 04 Aug 2024. Study ID: 1803628152 (IUSCC-0652)

Find a site

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Zip Code
Please provide your 5-digit zip code
0 0 /250
Other language

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the study team