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Immunosuppressant

Group B (tacrolimus, methotrexate, mycophenolate mofetil) for Leukemia

Phase 3
Waitlist Available
Led By Betty Hamilton, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights

Study Summary

This randomized clinical trial studies standard GVHD prophylaxis with tacrolimus and methotrexate compared to tacrolimus, mycophenolate mofetil and a reduced-dose methotrexate in patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplant. Both mycophenolate mofetil and reduced-dose methotrexate, in combination with a calcineurin inhibitor, have been shown to be safe and effective in GVHD prevention with less toxicity than standard dose methotrexate. It is not yet known, however, whether this combination of mycophenolate mofetil and reduced-dose methotrexate with tacrolimus is more effective than tacrolimus and standard dose methotrexate in preventing GVHD.

Eligible Conditions
  • Leukemia
  • Hodgkin's Lymphoma
  • Acute Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
  • Multiple Myeloma
  • Myeloproliferative Neoplasms
  • Acute Lymphoblastic Leukemia
  • Non-Hodgkin's Lymphoma
  • Biphenotypic Leukemia
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative Incidence of Participants With Acute GVHD
Percentage of Severe (Grade 3-4) Mucositis Graded According to the World Health Organization (WHO) Grading Scale
Time to Neutrophil Engraftment
+1 more
Secondary outcome measures
Incidence of Chronic GVHD
Incidence of Hepatotoxicity as Measured by Bilirubin
Incidence of Hepatotoxicity as Measured by Elevated Liver Enzymes
+11 more
Other outcome measures
Chimerism Results

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group B (tacrolimus, methotrexate, mycophenolate mofetil)Experimental Treatment3 Interventions
Patients receive tacrolimus as in group A and methotrexate (low dose) IV on days 1, 3, and 6. Patients also receive oral mycophenolate mofetil BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
Group II: Group A (tacrolimus, methotrexate)Active Control2 Interventions
Participants receive tacrolimus IV over 24 hours beginning on day -1 (or tacrolimus orally beginning on day -3) and then PO BID after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate mofetil
FDA approved
Methotrexate
FDA approved
Tacrolimus
FDA approved

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,809 Total Patients Enrolled
34 Trials studying Leukemia
1,558 Patients Enrolled for Leukemia
Betty Hamilton, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention
2014. "Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01951885.
~9 spots leftby Apr 2025
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