In this study, we are going to study the feasibility of transplantation from semi-matched (haploidentical) related donors in patients. We transplant 10 patients who haven’t any HLA matched related or unrelated donors with haploidentical related donor and CAMPATH and survey them with WBC and Platelet recovery and one six months survival.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706061030N2
Registration date:2008-09-29, 1387/07/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-09-29, 1387/07/08
Registrant information
Name
Mahdi Jalili
Name of organization / entity
Hematology-Oncology & SCT Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2662
Email address
m_jalili@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2006-09-01, 1385/06/10
Expected recruitment end date
2008-02-01, 1386/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H
Public title
Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H
Purpose
Treatment
Inclusion/Exclusion criteria
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)