Stem Cell Transplantation for Patients With Cancers of the Blood

INCLUSION CRITERIA

Recipient Criteria:

• Diagnosed with one of the following hematological conditions:
• Chronic myelogenous leukemia (CML): chronic phase who have failed treatment with imatinib, have intolerance to imatinib, or who did not receive imatinib at therapeutic doses within the first 12 months from diagnosis; accelerated phase or blast transformation.
• Acute B-lymphoblastic leukemia (B-ALL): any of these categories: B-ALL in first remission with high-risk features (presenting leukocyte count greater than 100,000/cu mm, Karyotypes t9; 22, t4, t19, t11, biphenotypic leukemia), all second or subsequent remissions, primary induction failure, partially responding or untreated relapse.
• Acute myelogenous leukemia (AML): AML in first remission - except AML with good risk karyotypes: AML M3 (t15; 17), AML M4Eo (inv 16), AML t (8; 21). All AML in second or subsequent remission, primary induction failure and resistant relapse.
• Myelodysplastic syndromes (MDS): any of these categories - refractory anemia with transfusion dependence, refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia, atypical MDS/myeloproliferative syndromes.
• Myeloproliferative disorders including atypical (Ph negative) chronic myeloid and neutrophilic leukemias, progressing myelofibrosis, and polycythemia vera, essential thrombocythemia in transformation to acute leukemia or with progressive transfusion requirements or pancytopenia.
• Chronic lymphocytic leukemia refractory to fludarabine treatment and with bulky progressive disease or with thrombocytopenia (less than or equal to 100,000 /microl) or anemia (less than or equal to 10g/dl) not due to recent chemotherapy.
• Non-Hodgkin's lymphoma including Mantle cell lymphoma relapsing or refractory to standard of care treatments.
• Multiple myeloma, Waldenstroms macroglobulinemia, unresponsive or relapsed following standard of care treatments.
• Ages 18-75 years inclusive.
• HLA identical (6/6) related donor.
• Ability to comprehend the investigational nature of the study and provide informed consent.

Donor Criteria:

• Related HLA identical (6/6) with recipient.
• Weight greater than or equal to 18 kg.
• Age greater than or equal to 2 or less than or equal to 80 years old.
• For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.

EXCLUSION CRITERIA

Recipient Criteria (any of the following):

• Malignant cells expressing a T cell phenotype (in particular T-ALL and T cell NHL).
• DLCO less than 65 percent predicted.
• Left ventricular ejection fraction less than 40 percent (evaluated by ECHO) or less than 30 percent (evaluated by MUGA).
• AST/SGOT greater than 10 times ULN (CTCAE grade IV v3.0).
• Bilirubin greater than 5 times ULN (CTCAE grade IV v3.0).
• Creatinine greater than 4.5 times ULN (CTCAE grade IV v 3.0).
• HIV positive (Recipients who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-1/II) are not excluded from participation).
• Positive pregnancy test for women of childbearing age.
• Prior allogeneic stem cell transplantation.
• Estimated probability of surviving less than three months.
• Major anticipated illness or organ failure incompatible with survival from transplant.
• Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible.

Donor Criteria (any of the following):

• Pregnant or lactating.
• Unfit to receive filgrastim (G-CSF) and undergo apheresis (abnormal blood counts, history of stroke, uncontrolled hypertension).
• Sickling hemoglobinopathies including HbSS, HbAS, HbSC.
• HIV positive Donors who are positive for hepatitis