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Multi Donor Mismatched Stem Cell Transplantation (MDT)

This study is currently recruiting participants.
Verified February 2016 by SHAPIRA MICHAEL, Hadassah Medical Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716690
First Posted: July 16, 2008
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
SHAPIRA MICHAEL, Hadassah Medical Organization
  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: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by SHAPIRA MICHAEL, Hadassah Medical Organization:

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

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

Estimated Enrollment: 10
Study Start Date: July 2008
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment Procedure: Multi donor stem cell transplantation
stem cell transplantation from 2 donors

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: SHAPIRA MICHAEL, Prof Shapira, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00716690     History of Changes
Other Study ID Numbers: MYS-04-HMO-CTIL
First Submitted: July 15, 2008
First Posted: July 16, 2008
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by SHAPIRA MICHAEL, Hadassah Medical Organization:
Stem cell transplantation
GVHD

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