Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies

Acute Myeloid Leukemia Clinical Trial

— IM-TMI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988013
• Other study ID #: 2009-0251
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: February 2016

Study information

• Verified date: May 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with the following diseases:
• Acute myeloid or lymphoblastic leukemia in first complete remission if poor prognosis documented by failure to response after initial induction chemotherapy, or cytogenetic, or molecular studies.
• Acute leukemia in greater/equal second remission, or partial remission after chemotherapy.
• High grade non Hodgkin's or Hodgkin's lymphoma with marrow involvement resistant/ relapsed after second line therapy including high dose chemotherapy and autologous SCT.
• CML in advanced or blastic phase.
• Plasma cell leukemia.
• Age 18-60 years.
• Karnofsky performance status of 70
• Adequate cardiac and pulmonary function. Patients with decreased LVEF less than/equal to 40% or DLCO less than/equal to 50% of predicted will require clearance from cardiology or pulmonary services, respectively, prior to enrollment on this protocol.
• Serum creatinine less than/equal to 1.5 mg/dL or Creatinine Clearance greater than/equal to 50 ml/min .
• Serum bilirubin 2.0 mg/dl, SGPT less than/equal to 3 times the upper limit of normal

Exclusion Criteria:

• Life expectancy is severely limited by concomitant illness.
• Evidence of chronic active hepatitis or cirrhosis
• HIV-positive
• Patient is pregnant
• Patient or guardian is not able to sign informed consent.

Related Conditions & MeSH terms

• Acute Leukemia
• Acute Myeloid Leukemia
• Chronic Myeloid Leukemia
• Hematologic Neoplasms
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Lymphoblastic Leukemia
• Non Hodgkins Lymphoma

Intervention

Radiation:
• IM-TMI (3Gy)
Patients will receive 3Gy per day for 1 day.
• IM-TMI (6Gy)
Patients will receive 3Gy per day for 2 days.
• IM-TMI (9Gy)
Patients will receive 3Gy per day for 3 days.
• IM-TMI (12Gy)
Patients will receive 3Gy per day for 4 days.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Grade 4 TMI Toxicity		1 year post-transplant
Primary	Number of Participants With 1 Year Mortality Unrelated to TMI		1 year post-transplant
Secondary	Time to Neutrophil and Platelet Engraftment in Patients With Hematologic Malignancies		Up to 100 days post-transplant