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

Phase 2

Completed

• Conditions: Haploidentical Hematopoietic Stem Cell Transplantation.

• Registration Number: IRCT138706061030N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion 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)

Study & Design

• Study Type: interventional
• Study Design: Not specified