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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


Phase 2
N/A
75 Years
Not Enrolling
Both
Hematological Malignancies

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Day-100 incidence of non-relapse mortality

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

Frederic Baron, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU-ULg

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

TJB0601

NCT ID:

NCT00504803

Start Date:

December 2006

Completion Date:

December 2010

Related Keywords:

  • Hematological Malignancies
  • HCT, nonmyeloablative, mesenchymal stem cells, GVHD
  • Neoplasms
  • Graft vs Host Disease
  • Hematologic Neoplasms

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