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Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease

Primary Purpose

Hematological Malignancies

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Mesenchymal stem cell infusion

About this trial

This is an interventional prevention trial for Hematological Malignancies focused on measuring HCT, nonmyeloablative, mesenchymal stem cells, GVHD

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

V.1. Patients

V.1.1. Diseases

Hematological malignancies confirmed histologically and not rapidly progressing:

AML in CR;
ALL in CR;
CML unresponsive/intolerant to Imatinib but not in blast crisis;
Other myeloproliferative disorders not in blast crisis and not with extensive myelofibrosis;
MDS with < 5% blasts;
Multiple myeloma;
CLL;
Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);
Hodgkin's disease.

V.1.2. Clinical situations

Theoretical indication for a standard allo-transplant, but not feasible because:
- Age > 55 yrs;
- Unacceptable end organ performance;
- Patient's refusal.
Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant.

V.1.3. Other inclusion criteria

Male or female; fertile female patients must use a reliable contraception method;
Age < 75 yrs.
Informed consent given by patient or his/her guardian if of minor age.

V.1.4. Exclusion criteria

Any condition not fulfilling inclusion criteria;
HIV positive;
Terminal organ failure, except for renal failure (dialysis acceptable);
Uncontrolled infection, arrhythmia or hypertension;
Previous radiation therapy precluding the use of 2 Gy TBI;
HLA-identical donor.

V.2. PBSC donors

V.2.1. Inclusion criteria

Related to the recipient (sibling, parent or child) or unrelated;
Male or female;
Weight > 15 Kg (because of leukapheresis);
Fulfills generally accepted criteria for allogeneic PBSC donation;
Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures.

V.2.2. Exclusion criteria

Any condition not fulfilling inclusion criteria;
HIV positive;
Unable to undergo leukapheresis because of poor vein access or other reasons.

V.2.3. HLA matching

Related or unrelated donors who have 1-2 HLA mismatches, as either :

One antigenic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
One allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
Two allelic mismatches at HLA-A or -B or -C or -DRB1 or -DQB1
One antigenic mismatch + 1 allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1.
One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B or -C or -DRB1

V.3. Cord blood unit

Banked cord blood units will be used if they fulfill the following criteria:

No more than 2/6 HLA mismatches (antigenic mismatch at HLA-A or HLA-B or allelic mismatch at HLA-DRB1)
> 2.5 x 107 TNC/kg
Standard validation by FACT/Netcord criteria.

Sites / Locations

CHU Sart Tilman

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

MSC co-infusion with either HLA-mismatched PBSC or cord blood

Outcomes

Primary Outcome Measures

Day-100 incidence of non-relapse mortality

Secondary Outcome Measures

1. Hematopoietic engraftment and graft rejection. 2. Incidence of grade II-IV and III-IV acute GVHD. 3. Immunologic reconstitution

Full Information

NCT ID

NCT00504803

First Posted

July 19, 2007

Last Updated

September 1, 2011

Sponsor

University of Liege

1. Study Identification

Unique Protocol Identification Number

NCT00504803

Brief Title

Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease

Official Title

Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning: a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Liege

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study

6. Conditions and Keywords

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

Hematological Malignancies

Keywords

HCT, nonmyeloablative, mesenchymal stem cells, GVHD

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

MSC co-infusion with either HLA-mismatched PBSC or cord blood

Intervention Type

Procedure

Intervention Name(s)

Mesenchymal stem cell infusion

Other Intervention Name(s)

Mesenchymal stem cells

Intervention Description

Infusion of mesenchymal stem cells on the same day as hematopoietic stem cell infusion.

Primary Outcome Measure Information:

Title

Day-100 incidence of non-relapse mortality

Time Frame

100 days

Secondary Outcome Measure Information:

Title

1. Hematopoietic engraftment and graft rejection. 2. Incidence of grade II-IV and III-IV acute GVHD. 3. Immunologic reconstitution

Time Frame

365 days

10. Eligibility

Sex

All

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

V.1. Patients V.1.1. Diseases Hematological malignancies confirmed histologically and not rapidly progressing: AML in CR; ALL in CR; CML unresponsive/intolerant to Imatinib but not in blast crisis; Other myeloproliferative disorders not in blast crisis and not with extensive myelofibrosis; MDS with < 5% blasts; Multiple myeloma; CLL; Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease); Hodgkin's disease. V.1.2. Clinical situations Theoretical indication for a standard allo-transplant, but not feasible because: Age > 55 yrs; Unacceptable end organ performance; Patient's refusal. Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant. V.1.3. Other inclusion criteria Male or female; fertile female patients must use a reliable contraception method; Age < 75 yrs. Informed consent given by patient or his/her guardian if of minor age. V.1.4. Exclusion criteria Any condition not fulfilling inclusion criteria; HIV positive; Terminal organ failure, except for renal failure (dialysis acceptable); Uncontrolled infection, arrhythmia or hypertension; Previous radiation therapy precluding the use of 2 Gy TBI; HLA-identical donor. V.2. PBSC donors V.2.1. Inclusion criteria Related to the recipient (sibling, parent or child) or unrelated; Male or female; Weight > 15 Kg (because of leukapheresis); Fulfills generally accepted criteria for allogeneic PBSC donation; Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures. V.2.2. Exclusion criteria Any condition not fulfilling inclusion criteria; HIV positive; Unable to undergo leukapheresis because of poor vein access or other reasons. V.2.3. HLA matching Related or unrelated donors who have 1-2 HLA mismatches, as either : One antigenic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1 One allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1 Two allelic mismatches at HLA-A or -B or -C or -DRB1 or -DQB1 One antigenic mismatch + 1 allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1. One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B or -C or -DRB1 V.3. Cord blood unit Banked cord blood units will be used if they fulfill the following criteria: No more than 2/6 HLA mismatches (antigenic mismatch at HLA-A or HLA-B or allelic mismatch at HLA-DRB1) > 2.5 x 107 TNC/kg Standard validation by FACT/Netcord criteria.

Overall Study Officials: