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

NCT00458250 | Completed Phase 1 DMC

• 1 other identifier: 418-A-1954
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 unrelated donor. Some researchers have been performed transplantation from semi-matched (haploidentical) related donors with relatively good results. Chinese researchers have been performed this kind of transplantation using CAMPATH-1H and their reports indicates good results. Chinese populations have more homogenous genetic background than Iranians. In this project, we are going to study the feasibility of this method of haploidentical transplantation in Iranian patients.

Conditions

Leukemia, Myeloid, Acute; Leukemia, Lymphoblastic, Acute

Keywords

Hematopoietic Stem Cell Transplantation; Haploidentical; Hematologic Neoplasms; human, Bone Marrow; Granulocyte Colony-stimulating Factor; CAMPATH; Alemtuzumab; AML; ALL; 10. Eligibility

Outcome Measures

Primary Outcomes (1)

• Engraftment one month after transplantation

  Up to 30 days from transplantation

Secondary Outcomes (1)

• six months survival

  Up to 180 days after transplantation

Interventions

Haploidentical hematopoietic stem cell transplantation PROCEDURE

Busulfan DRUG

Cyclophosphamide DRUG

CAMPATH-1H DRUG

Cyclosporin A DRUG

Methotrexate DRUG

Eligibility Criteria

• Age: 2 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Hematology-Oncology & BMT Research Center

Tehran, Tehran Province, 14114, Iran

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hematologic Neoplasms

Interventions

Busulfan; Cyclophosphamide; Alemtuzumab; Cyclosporine; Methotrexate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mohammadreza Ostadali, MD, Ph.D.

  Hematology-Oncology & BMT Research Center

  STUDY DIRECTOR

• Ardeshir Ghavamzadeh, MD

  Hematology-Oncology & BMT Research Center

  PRINCIPAL INVESTIGATOR

• Kamran Alimoghaddam, MD

  Hematology-Oncology & BMT Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2007
• First Posted: April 10, 2007
• Study Start: September 1, 2006
• Study Completion: February 1, 2008
• Last Updated: November 18, 2008

Record last verified: 2008-11

Locations

IR (1)