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Multi Donor Mismatched Stem Cell Transplantation (MDT)

Primary Purpose

Graft-Versus-Host Disease

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Multi donor stem cell transplantation

About this trial

This is an interventional treatment trial for Graft-Versus-Host Disease focused on measuring Stem cell transplantation, GVHD

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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).
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).
Each patient / patient's guardian must sign written informed consent.
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:

Not fulfilling any of the inclusion criteria.
Not in CR (if the indication for transplant is leukemia).
Active life-threatening infection.
Overt untreated infection.
HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
Pregnant or lactating women.
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).
Previous autologous or allogeneic stem cell transplantation.
Inability to comply with study requirements.

Sites / Locations

Hadassah Medical OrganizationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

Outcomes

Primary Outcome Measures

Day of neutrophil engraftment

Day of platelet engraftment>20x10(9)L

Acute GVHD occurrence>2

Disease free survival

Secondary Outcome Measures

Day of platelet engraftment>50x10(9)/L

Time of acute GVHD

GVHD grade

Overall survival

Infections incidence

transplant-related mortality

Transplant related toxicity

Immune reconstitution

Full Information

NCT ID

NCT00716690

First Posted

July 15, 2008

Last Updated

February 18, 2016

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00716690

Brief Title

Multi Donor Mismatched Stem Cell Transplantation (MDT)

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2008 (undefined)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Graft-Versus-Host Disease

Keywords

Stem cell transplantation, GVHD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Multi donor stem cell transplantation

Intervention Description

stem cell transplantation from 2 donors

Primary Outcome Measure Information:

Title

Day of neutrophil engraftment

Time Frame

30d

Title

Day of platelet engraftment>20x10(9)L

Time Frame

Title

Acute GVHD occurrence>2

Time Frame

100d

Title

Disease free survival

Time Frame

100d

Secondary Outcome Measure Information:

Title

Day of platelet engraftment>50x10(9)/L

Time Frame

30d

Title

Time of acute GVHD

Time Frame

100d

Title

GVHD grade

Time Frame

100d

Title

Overall survival

Time Frame

100 days

Title

Infections incidence

Time Frame

100d

Title

transplant-related mortality

Time Frame

100d

Title

Transplant related toxicity

Time Frame

100d

Title

Immune reconstitution

Time Frame

100d

10. Eligibility

Sex

All

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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). 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). Each patient / patient's guardian must sign written informed consent. 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: Not fulfilling any of the inclusion criteria. Not in CR (if the indication for transplant is leukemia). Active life-threatening infection. Overt untreated infection. HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis. Pregnant or lactating women. 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). Previous autologous or allogeneic stem cell transplantation. Inability to comply with study requirements.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Y Shapira, MD

Phone

00 972 2 6778351

shapiram@hadassah.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Y Shapira, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arik Tzukert, DMD

Phone

00 972 2 6776095

arik@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Hadas Lemberg, PhD

Phone

00 972 2 6777572

lhadas@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Shapira Y Michael, MD

12. IPD Sharing Statement

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Multi Donor Mismatched Stem Cell Transplantation (MDT)

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