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Platinum-containing Compound

R-ICE + Lenalidomide for Refractory Large B-Cell Lymphoma

Phase 1 & 2
Waitlist Available
Led By Grzegorz S Nowakowski
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
Measurable disease (at least 1 lesion >= 1.5 cm in diameter) as detected by PET/CT
Must not have
Men or women of childbearing potential who are unwilling to employ adequate contraception
Men must agree to use a latex condom during sexual contact with a female of child-bearing potential even if they have had a successful vasectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is studying the side effects and best dose of lenalidomide when given with R-ICE to see how well it works in treating patients with diffuse large B-cell lymphoma that has returned and is now refractory to treatment.

Who is the study for?
Adults with relapsed or refractory diffuse large B-cell lymphoma can join this trial. They must have measurable disease, be willing to take daily aspirin for blood clot prevention (or an alternative if allergic), and women of childbearing age need negative pregnancy tests and agree to use contraception. Participants should not have had more than one prior anti-lymphoma therapy and must be able to follow the study's requirements.
What is being tested?
The trial is testing the combination of lenalidomide with R-ICE chemotherapy (rituximab, ifosfamide, carboplatin, etoposide) in patients whose lymphoma has returned or didn't respond to initial treatment. It aims to find the safest dose of lenalidomide that works best when used with R-ICE.
What are the potential side effects?
Possible side effects include reactions at infusion sites, liver issues reflected by increased enzymes AST/ALT levels, fatigue, risk of infections due to low white blood cell counts (neutropenia), bleeding risks from low platelets count (thrombocytopenia), and potential heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have a tumor that is at least 1.5 cm big, confirmed by a PET/CT scan.
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I am able to care for myself and perform daily activities.
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My white blood cell count is healthy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not willing to use birth control.
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I agree to use a condom during sex if my partner can have children, even though I've had a vasectomy.
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I've had radiation therapy affecting a quarter of my bone marrow.
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I am currently taking medication to help with anemia.
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I am currently breastfeeding.
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I had a heart attack less than 6 months ago or need ongoing treatment for severe heart rhythm problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Overall Response Rate (Phase II)
Secondary study objectives
Complete Metabolic Response Rate
Overall Survival
Proportion of Patients Proceeding to Stem Cell Transplant
Other study objectives
Anatomic Size Reduction
Histologic Subtype (Germinal Center B-cell-like Versus Activated B-cell-like Versus Unclassified Subtype)
Minimum Residual Disease Blood Level
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (R2-ICE)Experimental Treatment6 Interventions
Patients receive lenalidomide PO daily on days 1-14, rituximab IV on day 1, ifosfamide IV over 24 hours on day 2, carboplatin IV over 1-2 hours on day 2, and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving CMR, PMR, or NMR may receive 2 more cycles per physician discretion. After completion of 2 cycles of R2ICE treatment, patients achieving objective status of CMR, PMR or NMR may proceed to SCT during the event monitoring phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2200
Lenalidomide
2005
Completed Phase 3
~1340
Carboplatin
2014
Completed Phase 3
~6120
Etoposide
2010
Completed Phase 3
~2960
Ifosfamide
2010
Completed Phase 4
~3140

Find a Location

Who is running the clinical trial?

Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
4,971 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,970 Total Patients Enrolled
Grzegorz S NowakowskiPrincipal InvestigatorAcademic and Community Cancer Research United
3 Previous Clinical Trials
508 Total Patients Enrolled

Media Library

Carboplatin (Platinum-containing Compound) Clinical Trial Eligibility Overview. Trial Name: NCT02628405 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Treatment (R2-ICE)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02628405 — Phase 1 & 2
Carboplatin (Platinum-containing Compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02628405 — Phase 1 & 2
~3 spots leftby Sep 2025
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