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Multi Donor Mismatched Stem Cell Transplantation (MDT)

This study is currently recruiting participants.
Verified February 2011 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00716690
First received: July 15, 2008
Last updated: March 1, 2011
Last verified: February 2011
History of Changes
  Purpose

The proposed research focuses on the development of innovative protocol of mismatched stem cell transplantation with combined 2 different haplo stem cell transplantation (SCT) donors which are mismatched to the recipient (and preferably to each other), in a patient in need for SCT, lacking an HLA match related or an unrelated donor. This innovative protocol named multi donor stem cell transplantation (MDT) is designed to facilitate engraftment even when reduced intensity conditioning or a low cell dose are used, improve the graft vs. leukemia (GVL) effect and enhance immune reconstitution (using quantitative and qualitative parameters).


Condition Intervention Phase
Graft-Versus-Host Disease
 Procedure: Multi donor stem cell transplantation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhancement of Hematopoietic Stem Cell Engraftment by Multi Donor Stem Cell Transplantation (MDT) From 2 Mismatched Donors, a Phase I-II Open Study

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Day of neutrophil engraftment [ Time Frame: 30d ] [ Designated as safety issue: Yes ]
  • Day of platelet engraftment>20x10(9)L [ Time Frame: 30 ] [ Designated as safety issue: Yes ]
  • Acute GVHD occurrence>2 [ Time Frame: 100d ] [ Designated as safety issue: Yes ]
  • Disease free survival [ Time Frame: 100d ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Day of platelet engraftment>50x10(9)/L [ Time Frame: 30d ] [ Designated as safety issue: Yes ]
  • Time of acute GVHD [ Time Frame: 100d ] [ Designated as safety issue: Yes ]
  • GVHD grade [ Time Frame: 100d ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • Infections incidence [ Time Frame: 100d ] [ Designated as safety issue: Yes ]
  • transplant-related mortality [ Time Frame: 100d ] [ Designated as safety issue: Yes ]
  • Transplant related toxicity [ Time Frame: 100d ] [ Designated as safety issue: Yes ]
  • Immune reconstitution [ Time Frame: 100d ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: July 2008
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Multi donor stem cell transplantation
    stem cell transplantation from 2 donors
  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patient age 0-70 years old with leukemia in 1st remission at high risk of relapse because of unfavorable prognostic features, at 2nd CR or MDS without an readily available matched donor (related or unrelated).
  2. Patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 HLA matching).
  3. Each patient / patient's guardian must sign written informed consent.
  4. Patients must have an ECOG PS ≤ 2; Creatinine <2.0 mg/dl; Ejection fraction >40%; DLCO >50% of predicted; Serum bilirubin <3 gm/dl; elevated GPT or GOT <3 x normal values.

Exclusion criteria:

  1. Not fulfilling any of the inclusion criteria.
  2. Not in CR (if the indication for transplant is leukemia).
  3. Active life-threatening infection.
  4. Overt untreated infection.
  5. HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
  6. Pregnant or lactating women.
  7. Donor contraindication (HIV seropositive confirmed by Western Blot, Hepatitis B antigenemia, HCV, evidence of bone marrow disease, unable to donate bone marrow or peripheral blood due to concurrent medical condition).
  8. Previous autologous or allogeneic stem cell transplantation.
  9. Inability to comply with study requirements.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716690

Contacts
Contact: Michael Y Shapira, MD 00 972 2 6778351 shapiram@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD     00 972 2 6776095     arik@hadassah.org.il    
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Principal Investigator: Shapira Y Michael, MD            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Michael Y Shapira, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Dr. Michael Shapira, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00716690     History of Changes
Other Study ID Numbers: MYS-04-HMO-CTIL
Study First Received: July 15, 2008
Last Updated: March 1, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Stem cell transplantation
GVHD

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013