Multi Donor Mismatched Stem Cell Transplantation (MDT)

NCT00716690 | Unknown Phase 1

• 1 other identifier: MYS-04-HMO-CTIL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Graft-Versus-Host Disease

Keywords

Stem cell transplantation; GVHD

Outcome Measures

Primary Outcomes (4)

• Day of neutrophil engraftment

  30d

• Day of platelet engraftment>20x10(9)L

  30

• Acute GVHD occurrence>2

  100d

• Disease free survival

  100d

Secondary Outcomes (8)

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

  30d

• Time of acute GVHD

  100d

• GVHD grade

  100d

• Overall survival

  100 days

• Infections incidence

  100d

Study Arms (1)

treatment

EXPERIMENTAL

Procedure: Multi donor stem cell transplantation

Interventions

Multi donor stem cell transplantation PROCEDURE

stem cell transplantation from 2 donors

treatment

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Michael Y Shapira, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Y Shapira, MD

CONTACT

00 972 2 6778351; shapiram@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Shapira

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 16, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

IL (1)