Early Use of Tacrolimus for Bone Marrow Transplant

Recruiting in Palo Alto (17 mi)

Overseen byMelhem Solh, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northside Hospital, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process

Research Team

Melhem Solh, MD

Principal Investigator

The Blood and Marrow Transplant Group of Georgia

Eligibility Criteria

This trial is for individuals with blood disorders who are undergoing a specific bone marrow transplant called HLA-mismatched haploidentical transplantation. They should not have an organic affective disorder that could interfere with the study.

Inclusion Criteria

I have a family donor who is a partial match and willing to donate stem cells.

I am able to care for myself but may not be able to do active work.

I am getting my first transplant from a donor, but I may have had a transplant using my own cells before.

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Exclusion Criteria

My heart's pumping ability is below 40%.

I am a woman who could get pregnant and am not using effective birth control or am currently pregnant.

Patients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow up

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Treatment Details

Interventions

Cyclophosphamide (Alkylating agents)
Mycofenolate mofetil (Other)
Tacrolimus (Immunosuppressant)

Trial OverviewThe trial tests if starting Tacrolimus early, along with Cyclophosphamide and Mycofenolate mofetil after stem cell transplant, can safely reduce Cytokine Release Syndrome more effectively than current methods.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Tacrolimus + MMF + Post-Transplant CyclophosphamideExperimental Treatment3 Interventions

Cyclophosphamide 50mg/kg/d Days +3 and +4 after transplant Tacrolimus Day -1 to Day +90 or Day +180 after transplant MMF 15mg/kg PO TID Day 0 to Day +35