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Corticosteroid
HDMP for Chronic Lymphocytic Leukemia
Phase 1
Waitlist Available
Led By Thomas Kipps, M.D., Ph.D.
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic diagnosis of Richter's Syndrome (RS)
No requirement nor restriction for prior therapy or stage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether a combination of 3 drugs can reduce the amount of cancer cells in people with Richter's Syndrome. The drugs are obinutuzumab, lenalidomide, and methylprednisolone. This combination is not approved for Richter's Syndrome and is considered experimental.
Eligible Conditions
- Richter Syndrome
- Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of the combination of obinutuzumab, lenalidomide, and high dose methylprednisolone in treatments with Richter's Syndrome (RS) measured Via Adverse Events
Secondary outcome measures
Overall response rate of RS and CLL
Overall survival rate
Patients able to receive a subsequent stem cell transplant (percentage)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: obinutuzumab, lenalidomide, and HDMPExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lenalidomide
2012
Completed Phase 3
~3920
HDMP
2017
Completed Phase 1
~10
Obinutuzumab
2015
Completed Phase 3
~3250
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,117 Previous Clinical Trials
1,520,284 Total Patients Enrolled
Thomas Kipps, M.D., Ph.D.Principal InvestigatorUniversity of California
Thomas J. Kipps, M.D., Ph.D.Principal InvestigatorUniversity of California
2 Previous Clinical Trials
15 Total Patients Enrolled
Frequently Asked Questions
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