MSC and HSC Coinfusion in Mismatched Minitransplants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2021-08-31

Brief Summary

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The present project aims at evaluating the capacity of MSC to improve one-year overall survival of patients transplanted with HLA-mismatched PBSC from related or unrelated donors after non-myeloablative conditioning.

Co-infusion of MSC has been shown to facilitate engraftment of hematopoietic stem cell (HSC) in an immunodeficient mouse model. In addition, it has been shown that infusion of third party MSC in HSC transplantation could be successfully used as treatment for grade II-IV steroid-refractory acute graft versus host disease.

One hundred and twenty patients with HLA-mismatched donors will be included over 6 years at multiple centers across Belgium through the transplant committee of the Belgian Hematological Society. The conditioning regimen will consist of fludarabine and 2 Gy TBI, followed by the infusion of donor HSC. Patients will be randomized 1/1 in double-blind fashion to receive or not MSC (1.5-.3.0 x106/kg) from third-party (either haploidentical family members or unrelated volunteer) donors on day 0. Postgrafting immunosuppression will combine tacrolimus and MMF. Except for the collection, expansion and infusion of MSC, the clinical management of the patient will not differ from that of routine NM-HCT.

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Detailed Description

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Conditions

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Leukemia, Myeloid, Acute Leukemia, Lymphoblastic, Acute Leukemia, Myelocytic, Chronic Myeloproliferative Disorders Myelodysplastic Syndromes Multiple Myeloma Leukemia, Lymphocytic, Chronic Hodgkin's Disease Lymphoma, Non-Hodgkin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Mensenchymal Stem Cells

Efficacy of MSC infusion on one-year overall survival of patients transplanted with HLA-mismatched PBSC.

Patients will receive a conditioning regimen consisting in fludarabine (total dose 90 mg/square meter) and 2 Gy total body irradiation.

MSC cells (1,5-3,0 x 10E6 MSC/Kg BW) will be injected, followed, at least one hour later, by the infusion of HLA-mismatched PBSC from related or unrelated donor.

Group Type EXPERIMENTAL

Mesenchymal stem cells

Intervention Type BIOLOGICAL

Mesenchymal stem cell injection

Placebo

Patients will receive a conditioning regimen consisting in fludarabine (total dose 90 mg/square meter) and 2Gy total body irradiation.

Isotonic solution will be injected will be injected, followed, at least one hour later, by the infusion of HLA-mismatched PBSC from related or unrelated donor.

Group Type PLACEBO_COMPARATOR

Isotonic solution

Intervention Type OTHER

Isotonic solution injection

Interventions

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Mesenchymal stem cells

Mesenchymal stem cell injection

Intervention Type BIOLOGICAL

Isotonic solution

Isotonic solution injection

Intervention Type OTHER

Eligibility Criteria

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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 -DQB1.
* 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 myelofibrosis
* MDS with \<5% blasts
* Multiple myeloma not rapidly progressing
* CLL
* Non-Hodgkin's lymphoma (aggressive NHL should be chemosensitive)
* Hodgkin's disease

* 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 hypertension
* 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 PBSC.

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No