Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H

This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Hematopoietic Stem Cell Transplantation, Haploidentical, Hematologic Neoplasms, human, Bone Marrow, Granulocyte Colony-stimulating Factor, CAMPATH, Alemtuzumab, AML, ALL, 10. Eligibility Read More

Inclusion Criteria:

INCLUSION CRITERIA - RECIPIENT: (all of the following)

• Ages 5-50 years
• Acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)
• Second remission (CR2) in standard risk patients or CR1 in cases with high-risk features (poor cytogenetic changes or secondary to myelodysplastic syndrome)
• Unavailability of HLA identical related donor or matched unrelated donor.
• Unavailability of other therapeutic intervention that prolongs patient survival.
• Lack of active infection.
• No history of allergy to CAMPATH.
• 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..
• Social and intellectual competency of the patient and his/her family to follow medical recommendations.

INCLUSION CRITERIA - DONOR:

• The donor must be haploidentical with the recipient: In the order of priority, siblings who have an identical paternal HLA haplotype with the patient, offspring (for female patients that do not have appropriate sibling), and mother.
• Possibly, it is better that the donor and recipient to be of same blood group and sex..
• Possibly, it is better that female donors not to be multiparous.
• Weight greater than or equal to 18 kg.
• Age between 2 and 60 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.
• Negative two-way WBC crossmatch with the recipient.

Exclusion Criteria:

EXCLUSION CRITERIA - RECIPIENT: (ANY OF THE FOLLOWING)

• Major anticipated illness or organ failure incompatible with survival from transplantation.
• Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the transplantation procedure unlikely and making informed consent impossible.
• Positive pregnancy test for women of childbearing age.
• HIV positive
• Active infection
• Left ventricular ejection fraction less than 40%
• AST/SGOT greater than 20 x ULN (CTCAE grade IV v3.0)
• Bilirubin greater than 10 x ULN (CTCAE grade IV v3.0)
• Creatinine greater than 6 x ULN (CTCAE grade IV v 3.0)
• Occurrence of allergy symptoms and signs during CAMPATH infusion. EXCLUSION CRITERIA - DONOR: (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
• HBsAg or HIV positive
• Active infection
• CMV positive (for CMV negative recipients)
• Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely and making informed consent impossible
• Contraindication to general anesthesia.