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Immunomodulatory Agent
Lenalidomide for Lymphoma
Phase 1 & 2
Waitlist Available
Led By Loretta Nastoupil
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hemoglobin >= 9.0 g/dL
Able and willing to provide written informed consent and to comply with the study protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of lenalidomide when given with obinutuzumab to treat patients with low-grade NHL that has returned.
Eligible Conditions
- Lymphoma
- Follicular Lymphoma
- Marginal Zone Lymphoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of DLTs after course 1 assessed using NCI CTCAE version 4 (Phase II)
Maximum tolerated dose of lenalidomide when given with obinutuzumab defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT) (Phase I)
Overall response rate (complete response + partial response) (Phase II)
Secondary outcome measures
Overall survival
Progression-free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (lenalidomide, obinutuzumab)Experimental Treatment3 Interventions
Patients receive lenalidomide PO QD on days on days 2-22 and obinutuzumab IV over 4-5 hours on days 1, 2, 8, 15, and 22 of cycle 1 and on day 1 of each subsequent cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients not experiencing progression and who in the opinion of treating physician are deriving benefit from combination treatment may continue lenalidomide for an additional 6 cycles (up to cycle 12) and obinutuzumab on day 1 every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Obinutuzumab
2015
Completed Phase 3
~3250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,395 Total Patients Enrolled
253 Trials studying Lymphoma
32,522 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,613 Previous Clinical Trials
40,918,235 Total Patients Enrolled
1,376 Trials studying Lymphoma
381,514 Patients Enrolled for Lymphoma
Loretta NastoupilPrincipal InvestigatorM.D. Anderson Cancer Center
Frequently Asked Questions
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