Status:
COMPLETED
Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H
Lead Sponsor:
Tehran University of Medical Sciences
Conditions:
Leukemia, Myeloid, Acute
Leukemia, Lymphoblastic, Acute
Eligibility:
All Genders
2-50 years
Phase:
PHASE1
Brief Summary
Many patients suffering various malignant and non-malignant diseases need hematopoietic stem cell transplantation from a healthy person. In the majority of cases there is no matched related or unrelat...
Detailed Description
Haploidentical hematopoietic stem cell transplantation is a very important therapeutic intervention for treatment of some genetic disorders and hematological malignancies. In the majority of cases, t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00458250
Start Date
September 1 2006
End Date
February 1 2008
Last Update
November 18 2008
Active Locations (1)
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1
Hematology-Oncology & BMT Research Center
Tehran, Tehran Province, Iran, 14114