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Omission of the drug mycophenolate mofetil for Blood Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Blood CancersOmission of the drug mycophenolate mofetil - Other
Eligibility
18 - 75
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether omitting MMF from the standard stem cell transplant treatment protocol is feasible, safe and potentially beneficial. 60 patients will be followed for up to 2 years to see what happens.

Eligible Conditions
  • Blood Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Hematopoietic Cell Transplantation
1
Mycophenolate Mofetil
1
RIC- alloBMT with high PTCy in SSc

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 1-year post-transplant and 2-years post-transplant

Year 2
Relapse
1-year post- transplant and 2-years post-transplant
Graft Versus Host Disease (GVHD)-free, Relapse Free Survival
1-year post-transplant
Rate of severe chronic GVHD at 1 year
1-year post-transplant and 2-years post-transplant
Overall Survival (OS)
100 days post-transplant
Rate of severe acute GVHD by day +100.
Day 5
Treatment-related mortality
60 days post-transplant
Engraftment failure
Time to neutrophil and platelet engraftment

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Hematopoietic Cell Transplantation
1
Mycophenolate Mofetil
1
RIC- alloBMT with high PTCy in SSc

Trial Design

1 Treatment Group

Open Arm
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Omission of the drug mycophenolate mofetil · No Placebo Group · N/A

Open Arm
Other
Experimental Group · 1 Intervention: Omission of the drug mycophenolate mofetil · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1-year post-transplant and 2-years post-transplant

Who is running the clinical trial?

Ronald PaquetteLead Sponsor
Ronald Paquette, MDPrincipal InvestigatorCedars-Sinai Medical Center
4 Previous Clinical Trials
16 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a related donor and have a haploidentical or unrelated donor.
References

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