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Multi Donor Mismatched Stem Cell Transplantation (MDT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
SHAPIRA MICHAEL, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00716690
First received: July 15, 2008
Last updated: February 18, 2016
Last verified: February 2016

July 15, 2008
February 18, 2016
July 2008
January 2020   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00716690 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Multi Donor Mismatched Stem Cell Transplantation (MDT)
Enhancement of Hematopoietic Stem Cell Engraftment by Multi Donor Stem Cell Transplantation (MDT) From 2 Mismatched Donors, a Phase I-II Open Study
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).
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Graft-Versus-Host Disease
Procedure: Multi donor stem cell transplantation
stem cell transplantation from 2 donors
Experimental: treatment
Intervention: Procedure: Multi donor stem cell transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
June 2020
January 2020   (final data collection date for primary outcome measure)

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.
Both
up to 70 Years   (Child, Adult, Senior)
No
Contact: Michael Y Shapira, MD 00 972 2 6778351 shapiram@hadassah.org.il
Israel
 
NCT00716690
MYS-04-HMO-CTIL
No
Not Provided
Not Provided
SHAPIRA MICHAEL, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Michael Y Shapira, MD Hadassah Medical Organization
Hadassah Medical Organization
February 2016

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