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

This study is currently recruiting participants.
Verified January 2013 by University of Illinois
Sponsor:
Information provided by (Responsible Party):
Damiano Rondelli, MD, University of Illinois
ClinicalTrials.gov Identifier:
NCT00988013
First received: September 30, 2009
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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%.


Condition Intervention Phase
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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:
  • To determine the overall toxicity and day 100 transplant related mortality [ Time Frame: Up do 100 days post-transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the time to neutrophil and platelet engraftment in patients with hematologic malignancies [ Time Frame: Up to 100 days post-transplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: September 2009
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988013

Contacts
Contact: Damiano Rondelli, MD (312) 996-6179 drond@uic.edu
Contact: Alisha Williams, RN (312) 413-2746 alishaw@uic.edu

Locations
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Alisha Williams, RN     312-413-2746     alishaw@uic.edu    
Contact: Pritesh Patel, MD     (312) 996-5762     prpatel8@uic.edu    
Principal Investigator: Damiano Rondelli, MD            
Sponsors and Collaborators
University of Illinois
Investigators
Study Chair: Damiano Rondelli, MD University of Illinois
  More Information

No publications provided

Responsible Party: Damiano Rondelli, MD, Professor, University of Illinois
ClinicalTrials.gov Identifier: NCT00988013     History of Changes
Other Study ID Numbers: 2009-0251
Study First Received: September 30, 2009
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois:
total marrow irradiation
intensity modulated radiation
leukemia
hematologic diseases

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Hematologic Neoplasms
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Site

ClinicalTrials.gov processed this record on June 17, 2013