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

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00458250
First received: April 7, 2007
Last updated: November 15, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Leukemia, Myeloid, Acute
Leukemia, Lymphoblastic, Acute
Procedure: Haploidentical hematopoietic stem cell transplantation
Drug: Busulfan
Drug: Cyclophosphamide
Drug: CAMPATH-1H
Drug: Cyclosporin A
Drug: Methotrexate
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Engraftment one month after transplantation [ Time Frame: Up to 30 days from transplantation ]

Secondary Outcome Measures:
  • six months survival [ Time Frame: Up to 180 days after transplantation ]

Estimated Enrollment: 10
Study Start Date: September 2006
Study Completion Date: February 2008
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, there is no matched related or unrelated donor. Haploidentical hematopoietic stem cell transplantation is a promising alternative for critical cases.

To avoid severe graft versus host disease (GVHD), two types of T cell depletion (TCD) had been used: total TCD and partial TCD.

Total TCD has disadvantages such as increased rate of rejection and relapse, and increased rate of infections due to delayed immune reconstitution.

Partial TCD has been done by in vivo and/or in vitro methods. In haploidentical transplantation, donor partial TCD (ex vivo TCD) without recipient TCD increases the rate of rejection and can not prevent severe GVHD successfully.

In vivo TCD by partial depletion of donor and recipient T cells has been done in haploidentical transplantation with good results (to some extent inferior to full matched transplantations) by using CAMPATH, ATG, etc.

Most of these studies have been performed in Chinese and Japanese populations that have more homogenous genetic background than other populations.

In order to study the feasibility of this kind of transplantation in Iranian patients, we defined a project to perform haploidentical hematopoietic stem cell transplantation by using in vivo CAMPATH-1H.

  Eligibility

Ages Eligible for Study:   2 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458250

Locations
Iran, Islamic Republic of
Hematology-Oncology & BMT Research Center
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Director: Mohammadreza Ostadali, MD, Ph.D. Hematology-Oncology & BMT Research Center
Principal Investigator: Ardeshir Ghavamzadeh, MD Hematology-Oncology & BMT Research Center
Principal Investigator: Kamran Alimoghaddam, MD Hematology-Oncology & BMT Research Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00458250     History of Changes
Other Study ID Numbers: 418-A-1954
Study First Received: April 7, 2007
Last Updated: November 15, 2008
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Hematopoietic Stem Cell Transplantation
Haploidentical
Hematologic Neoplasms
human, Bone Marrow
Granulocyte Colony-stimulating Factor
CAMPATH
Alemtuzumab
AML
ALL
10. Eligibility

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Methotrexate
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on September 30, 2014