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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2990

Lenalidomide

2005

Completed Phase 3

~2240