MSC and HSC Coinfusion in Mismatched Minitransplants

  • STATUS
    Recruiting
  • End date
    Jul 25, 2023
  • participants needed
    120
  • sponsor
    University of Liege
Updated on 25 January 2021
cancer
hypertension
coronary artery disease
remission
graft versus host disease
fludarabine
hematologic malignancy
tacrolimus
blast crisis
mycophenolate mofetil
imatinib
hla-a
lymphoma
multiple myeloma
hodgkin's disease
myeloproliferative disorder
ejection fraction
myeloablative conditioning
transplant conditioning
serum bilirubin level

Summary

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.

Details
Condition Bone marrow disorder, childhood ALL, Hodgkin's Disease, Multiple Myeloma, Lymphoma, Preleukemia, Acute myeloid leukemia, Lymphoproliferative Disorder, Lymphoma, Chronic Lymphocytic Leukemia, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Chronic myeloid leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Myeloproliferative Neoplasms, Lymphocytic Leukemia, Acute, Lymphoproliferative disorders, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, non-hodgkin's lymphoma (nhl), leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, multiple myeloma (mm), myelodysplastic syndrome (mds), hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), chronic myelogenous leukemia
Treatment Mesenchymal stem cells, Isotonic solution, Isotonic solution
Clinical Study IdentifierNCT01045382
SponsorUniversity of Liege
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic Lymphocytic Leukemia or Bone marrow disorder or MYELODYSPLASTIC SYNDROME or Lymphocytic Leukemia, Chronic or Preleukemia or childhood ALL or L...?
Do you have any of these conditions: Lymphocytic Leukemia, Chronic or myelodysplastic syndromes or chronic myelogenous leukemia or Lymphoma or MYELODYSPLASTIC SYNDROME or non-hodgkin's ly...?
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 HLA-A, -B, -C, DRB1 and DQBI allele-matched donor fit to/willing to donate PBSC
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note