Overview

Gemtuzumab Ozogamicin, Fludarabine, and Total-body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

Status:
Completed
Trial end date:
2002-07-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin combined with fludarabine and total-body irradiation followed by donor peripheral stem cell or bone marrow transplantation in treating patients who have advanced acute myeloid leukemia or myelodysplastic syndrome.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cyclosporine
Cyclosporins
Fludarabine
Fludarabine phosphate
Gemtuzumab
Methotrexate
Mycophenolate mofetil
Mycophenolic Acid
Vidarabine
Criteria
DISEASE CHARACTERISTICS: Diagnosis of recurrent or refractory acute myeloid leukemia CD33
positive Greater than 5% morphologically identified blasts in the marrow OR Diagnosis of
myelodysplastic syndrome CD33 positive Greater than 5% morphologically identified blasts in
the marrow (refractory anemia with excess blasts (RAEB) and RAEB in transformation) Must
have donor who meets the following criteria: HLA-A, B, C, DRB1 and DQB1 identical or
mismatched for no more than 1 allelic or cross-reactive antigen Under 75 years of age

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy:
Not specified Hematopoietic: WBC no greater than 30,000/mm3 (leukophereses or hydroxyurea
allowed) Hepatic: Bilirubin no greater than 2 times upper limit of normal No synthetic
dysfunction No severe cirrhosis Renal: Not specified Cardiovascular: No symptomatic
coronary artery disease No cardiac failure requiring therapy Pulmonary: DLCO at least 35%
OR Receiving supplementary continuous oxygen Other: No uncontrolled infection No other
diseases that would severely limit life expectancy Not pregnant or nursing Fertile patients
must use effective contraception during and for 1 year after study

PRIOR CONCURRENT THERAPY: No post-transplant growth factors during and for 1 month after
mycophenolate mofetil administration