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Alkylating agents

Mycophenolate mofetil for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Led By Zeina Al-Mansour, MD
Research Sponsored by Loyola University
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 3 years
Awards & highlights

Summary

This trial is testing the effectiveness of a new way to do a stem cell transplant using a donor who is only a partial match.

Eligible Conditions
  • Chronic Lymphocytic Leukemia
  • Acute Lymphoblastic Leukemia
  • Non-Hodgkin's Lymphoma
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chimerism
Secondary study objectives
Disease status with blast counts (immature blood cell count) above 5%
Frequency and severity of chronic GVHD
Grade 3 through 5 Adverse Events
+5 more

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT01801280
21%
Common cold
5%
Noro virus infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mycophenolate Mofetil (MMF)
MMF + PAN
EC-MPS
EC-MPS + PAN

Trial Design

1Treatment groups
Experimental Treatment
Group I: All patients will receive HaploidenticalExperimental Treatment4 Interventions
The choice of the chemotherapy treatment for transplantation will be up to the investigator. Post-transplant cyclophosphamide will serve as the backbone of the immunosuppression treatment to prevent GVHD. All patients will receive a Haplo-identical stem cell transplantation. GVHD Prevention Treatment: Cyclophosphamide 50mg/kg will be administered IV on Day 3 and Day 5 post transplant. Tacrolimus 0.03 mg/kg daily will be administered IV until patient can take it by mouth starting on day of transplant and continue approximately 100 days post-transplant. Mycophenolate mofetil 15mg/kg will be administered twice a day IV until patient can take it by mouth starting on Day 1 post transplant until 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
FDA approved
Mycophenolate mofetil
FDA approved
Cyclophosphamide
FDA approved

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor
159 Previous Clinical Trials
31,254 Total Patients Enrolled
Zeina Al-Mansour, MDPrincipal InvestigatorCardinal Bernardin Cancer Center, Loyola University
1 Previous Clinical Trials
98 Total Patients Enrolled
~1 spots leftby Sep 2025
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