Donor Peripheral Stem Cell Transplant and Donor Natural Killer Cell Transplant After Total-Body Irradiation, Thiotepa, Fludarabine, and Muromonab-CD3 in Treating Patients With Leukemia or Other Blood Diseases

• Status: Terminated
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell and donor natural killer cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving a donor peripheral stem cell transplant and a donor natural killer cell transplant after total-body irradiation, thiotepa, fludarabine, and muromonab-CD3 works in treating patients with leukemia or other blood diseases.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborators: National Cancer Institute (NCI); National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Fludarabine; Fludarabine phosphate; Methotrexate; Muromonab-CD3; Thiotepa; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following life-threatening hematological malignancies:

• Acute lymphoblastic leukemia meeting 1 of the following criteria:

• Advanced beyond first remission

• In first remission with high-risk prognostic features, including any of the following:

• Philadelphia chromosome-positive disease

• Chromosome 11q23 abnormality

• Hypodiploid

• Failed to achieve first remission within 1 month after induction

• Acute myeloid leukemia (AML) meeting 1 of the following criteria:

• Advanced beyond first remission

• First remission with high-risk prognostic features, including any of the following:

• Chromosome 11q23 abnormality

• Chromosome del 7q

• Secondary AML

• Failed to achieve first remission within 1 month after induction

• Myelodysplastic syndromes with International Prognostic Score > 1

• Chronic myelogenous leukemia in accelerated or blastic phase

• No active CNS disease

• No suitable HLA-matched related or unrelated donor available

• Haploidentical family member available as donor of partially HLA-matched peripheral blood stem cells

• Least degree of mismatch to HLA-A, B, C, DRB1, and DQB1

• No mismatch for a single HLA-A, B, C, DRB1, or DQB1 antigen

• Donor killer cell immunoglobulin-like receptor ligand group expression preferably different than patient

PATIENT CHARACTERISTICS:

• LVEF ≥ 45%

• DLCO ≥ 60% of predicted

• AST and ALT ≤ 2 times upper limit of normal (ULN) (unless due to malignancy)

• Bilirubin ≤ 2 times ULN (unless due to malignancy)

• No life expectancy < 6 months due to coexisting disease other than the malignancy

• No active infection (e.g., polymerase chain reaction [PCR] evidence for cytomegalovirus, human herpes virus 6, or invasive fungal infection)

• No prior infections without evidence of resolution by PCR or imaging studies within the past 2 months

• No hypersensitivity to murine antibodies

• No known HIV positivity

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• No prior marrow transplantation with total body irradiation > 400 cGy

• No concurrent therapies for seizure disorder

• No growth factors for 21 days after transplantation