Multi Donor Mismatched Stem Cell Transplantation (MDT)

Graft-Versus-Host Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00716690
• Other study ID #: MYS-04-HMO-CTIL
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 15, 2008
• Last updated: February 18, 2016
• Start date: July 2008
• Est. completion date: June 2020

Study information

• Verified date: February 2016
• Source: Hadassah Medical Organization
• Contact: Michael Y Shapira, MD
• Phone: 00 972 2 6778351
• Email: shapiram[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-Versus-Host Disease

Intervention

Procedure:
• Multi donor stem cell transplantation
stem cell transplantation from 2 donors

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Day of neutrophil engraftment		30d	Yes
Primary	Day of platelet engraftment>20x10(9)L		30	Yes
Primary	Acute GVHD occurrence>2		100d	Yes
Primary	Disease free survival		100d	Yes
Secondary	Day of platelet engraftment>50x10(9)/L		30d	Yes
Secondary	Time of acute GVHD		100d	Yes
Secondary	GVHD grade		100d	Yes
Secondary	Overall survival		100 days	Yes
Secondary	Infections incidence		100d	Yes
Secondary	transplant-related mortality		100d	Yes
Secondary	Transplant related toxicity		100d	Yes
Secondary	Immune reconstitution		100d	Yes