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
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.