Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies (IM-TMI)
This is a phase I study using Intensity Modulated Total Marrow Irradiation (IM-TMI) in addition to a chemotherapy regimen in preparation for an allogeneic stem cell transplant for advanced hematologic malignancies such as acute myeloid or lymphoblastic leukemia, high grade non Hodgkin's or Hodgkin's lymphoma, chronic myelogenous leukemia, and plasma cell leukemia. Because the subjects participating in this study have a disease that is severe and has a high risk of relapse even after transplant, the investigators propose to use a chemotherapy regimen (fludarabine/busulfan), the name for the combination of chemotherapy drugs that is given to patients prior to transplantation of the donor stem cells, along with intensity modulated radiation (IM-TMI) to the bone marrow. Total body irradiation (TBI) in conjunction with chemotherapy is a standard of care as a pre-conditioning regimen prior to bone marrow transplant (BMT) in patients with hematologic malignancies. However, TBI can cause severe side effects due to irradiation of organs such as the lenses of the eye, whole brain, lungs, liver, kidneys, heart, small bowel and oral cavity. IM-TMI allows for the delivery of adequate doses of radiation to the bone marrow while sparing other organs and therefore limiting radiation side effects. The irradiation, along with receiving the chemotherapy drugs will suppress the subject's immune system and kill off tumor cells, but will also intensify the effect of the conditioning regimen thus allowing the bone marrow transplantation to have a greater chance of being successful.
No investigational drugs are used in this study. The investigational part of this study is the use of intensity modulated total marrow irradiation instead of conventional radiation. IMTMI can deliver 99% of the prescribed treatment to the targeted bones and reduce the doses of radiation to surrounding organs, as received in conventional TBI, by 29% to 65%.
|Acute Myeloid Leukemia Lymphoblastic Leukemia Acute Leukemia Non Hodgkins Lymphoma Chronic Myeloid Leukemia||Radiation: IM-TMI (3Gy) Radiation: IM-TMI (6Gy) Radiation: IM-TMI (9Gy) Radiation: IM-TMI (12Gy)||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies|
- To determine the overall toxicity and day 100 transplant related mortality [ Time Frame: Up do 100 days post-transplant ]
- To determine the time to neutrophil and platelet engraftment in patients with hematologic malignancies [ Time Frame: Up to 100 days post-transplant ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Experimental: IM-TMI (3Gy)
Patients will receive 3Gy per day for 1 day (total of 3Gy).
Radiation: IM-TMI (3Gy)
Patients will receive 3Gy per day for 1 day.
Experimental: IM-TMI (6Gy)
Patients will receive 3Gy per day for 2 days (for a total of 6Gy).
Radiation: IM-TMI (6Gy)
Patients will receive 3Gy per day for 2 days.
Experimental: IM-TMI (9Gy)
Patients will receive 3Gy per day for 3 days (for a total of 9Gy).
Radiation: IM-TMI (9Gy)
Patients will receive 3Gy per day for 3 days.
Experimental: IM-TMI (12Gy)
Patients will receive 3Gy per day for 4 days (for a total of 12Gy).
Radiation: IM-TMI (12Gy)
Patients will receive 3Gy per day for 4 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988013
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Study Chair:||Damiano Rondelli, MD||University of Illinois at Chicago|