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Co-transplantation of Mesenchymal Stem Cells and HLA-mismatched Allogeneic Hematopoietic Cells After Nonmyeloablative Conditioning: a Phase II Randomized Double-blind Study

Phase 2
75 Years
Open (Enrolling)
Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute, Leukemia, Myelocytic, Chronic, Myeloproliferative Disorders, Myelodysplastic Syndromes, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, Hodgkin's Disease, Lymphoma, Non-Hodgkin

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Trial Information

Co-transplantation of Mesenchymal Stem Cells and HLA-mismatched Allogeneic Hematopoietic Cells After Nonmyeloablative Conditioning: a Phase II Randomized Double-blind Study

Inclusion Criteria:

- 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.

- Male or female; fertile female patients must use a reliable contraception method

- Age ≤ 75 year old

- Informed consent given by patient or his/her guardian if of minor age.

- One or two HLA mismatches with PBSC:

- One antigenic 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

- One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B
or -C or -DRB1

- Patients with one single allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
can also be included in the protocol.

- Hematological malignancies confirmed histologically and not rapidly progressing:

- AML in complete remission

- ALL in complete remission

- CML unresponsive/intolerant to Imatinib but not in blast crisis

- Other myeloproliferative disorders not in blast crisis and not with extensive

- MDS with <5% blasts

- Multiple myeloma not rapidly progressing


- Non-Hodgkin's lymphoma (aggressive NHL should be chemosensitive)

- Hodgkin's disease

Exclusion Criteria:

- Any condition not fulfilling inclusion criteria

- HIV positive

- Terminal organ failure, except for renal failure (dialysis acceptable)

- Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring
therapy; ejection fraction <35%; uncontrolled arrhythmia; uncontrolled

- Pulmonary: DLCO < 35% and/or receiving supplementary continuous oxygen

- Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal
hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding
esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic
dysfunction evinced by prolongation of the prothrombin time, ascites related to
portal hypertension, bacterial or fungal liver abscess, biliary obstruction,
chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic
biliary disease

- Uncontrolled infection, arrhythmia or hypertension

- Previous radiation therapy precluding the use of 2 Gy TBI

- 10/10 HLA-A, -B, -C, DRB1 and DQBI allele-matched donor fit to/willing to donate

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

One-year overall survival in the 2 arms.

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Yves Beguin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

July 2010

Completion Date:

July 2018

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Leukemia, Lymphoblastic, Acute
  • Leukemia, Myelocytic, Chronic
  • Myeloproliferative Disorders
  • Myelodysplastic Syndromes
  • Multiple Myeloma
  • Leukemia, Lymphocytic, Chronic
  • Hodgkin's Disease
  • Lymphoma, Non-Hodgkin
  • HSC transplantation
  • HLA-mismatched
  • Mesenchymal stem cells
  • GVHD
  • co-infusion
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders