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

April 7, 2007
November 15, 2008
September 2006
Not Provided
Engraftment one month after transplantation [ Time Frame: Up to 30 days from transplantation ]
Engraftment one month after transplantation
Complete list of historical versions of study NCT00458250 on ClinicalTrials.gov Archive Site
six months survival [ Time Frame: Up to 180 days after transplantation ]
six months survival
Not Provided
Not Provided
 
Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H
Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia, Myeloid, Acute
  • Leukemia, Lymphoblastic, Acute
  • Procedure: Haploidentical hematopoietic stem cell transplantation
  • Drug: Busulfan
  • Drug: Cyclophosphamide
  • Drug: CAMPATH-1H
  • Drug: Cyclosporin A
  • Drug: Methotrexate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
February 2008
Not Provided

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.
Both
2 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00458250
418-A-1954
Yes
Not Provided
Tehran University of Medical Sciences
Not Provided
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
Tehran University of Medical Sciences
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP