IRCT138706061030N2
Completed
Phase 2
Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tehran University of Medical Sciences
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •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.
- •No history of allergy to CAMPATH.
- •The donor must be haploidentical with the recipient.
- •Weight greater than or equal to 18 kg.
- •Age between 2 and 60 years old.
Exclusion Criteria
- •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.
- •HIV positive
- •Active infection
- •Positive pregnancy test for women of childbearing age.
- •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\)
- •Pregnant or lactating
Outcomes
Primary Outcomes
Not specified
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