]>
IRCT138706061030N2 IRCT 2008-09-29 Tehran University of Medical Sciences Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H 2006-09-01 anticipated 10 Complete https://irct.ir/trial/14 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Haploidentical Hematopoietic Stem Cell Transplantation. Procedure: Haploidentical hematopoietic stem cell transplantation Drug: Busulfan,Cyclophosphamide,CAMPATH-1H,Cyclosporin A,Methotrexate.
public Mohammadreza Ostadali
Kargar Ave. Shariati Hospital
Tehran Iran (Islamic Republic of) 14114 +98 21 8490 2626 ostadali@sina.tums.ac.ir Hematology-Oncology and SCT Research Center scientific Mohammadreza Ostadali
Kargar Ave. Shariati Hospital
Tehran Iran (Islamic Republic of) 14114 +98 21 8490 2626 ostadali@sina.tums.ac.ir Hematology-Oncology and SCT Research Center Iran (Islamic Republic of) Inclusion Criteria: Recipient: 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. Donor: The donor must be haploidentical with the recipient. Weight greater than or equal to 18 kg. Age between 2 and 60 years old. Negative two-way WBC crossmatch with the recipient. 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 Recipient: 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) Donor: 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 positive CMV positive (for CMV negative recipients) 18 years 65 years Both Procedure: Haploidentical hematopoietic stem cell transplantation Drug: Busulfan,Cyclophosphamide,CAMPATH-1H,Cyclosporin A,Methotrexate Engraftment one month after transplantation. Timepoint: 30 days from transplantation. Method of measurement: Count of WBC and Platelet. Six months survival. Timepoint: 180 days after transplantation. Method of measurement: Live patients after 180 days. NCT00458250 clinicaltrials.gov Tehran University of Medical Sciences Approved 2006-10-28 Ethics Committee of HORC-BMT Kargar Ave. Shariati Hospital Tehran Iran (Islamic Republic of)