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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00716690

Enrollment

Registered

2008-07-16

Start date

2008-07-31

Completion date

2020-06-30

Last updated

2016-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft-Versus-Host Disease

Keywords

Stem cell transplantation, GVHD

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).

Interventions

PROCEDUREMulti donor stem cell transplantation

stem cell transplantation from 2 donors

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Day of neutrophil engraftment	30d
Day of platelet engraftment>20x10(9)L	30
Acute GVHD occurrence>2	100d
Disease free survival	100d

Secondary

Measure	Time frame
Infections incidence	100d
transplant-related mortality	100d
Day of platelet engraftment>50x10(9)/L	30d
Immune reconstitution	100d
Transplant related toxicity	100d
Time of acute GVHD	100d
GVHD grade	100d
Overall survival	100 days

Countries

Israel

Contacts

Primary ContactMichael Y Shapira, MD

shapiram@hadassah.org.il00 972 2 6778351

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026