Status:
COMPLETED
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Acute Myeloid Leukemia
Lymphoblastic Leukemia
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00988013
Start Date
September 1 2009
End Date
February 1 2016
Last Update
June 14 2021
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612