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Immunomodulatory Agent

Revlimid (Lenalidomide) in Combination for Non-Hodgkin's Lymphoma (RICER Trial)

Phase 1 & 2

Waitlist Available

Led By Tatyana Feldman, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the RICE therapy and again after transplant as maintenance. To improve over all outcome and survival. Hypothesis is that combining lenalidomide with standard of care (RICE) may increase overall response rate thus increasing the number of patients able to proceed with autologous stem cell transplant. This in turn may translate into improved overall survival and progression free survival.

Eligible Conditions

Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Stage I - Safety (Type, Frequency, Severity and Relationship of Adverse Events to Study Treatment) and Tolerability

Stage II - Overall Response Rate

Stage III - Overall Response Rate

Secondary study objectives

Stage I - Dose Limiting Toxicity Incidence Rate

Stage II - 1 Year Overall Survival (OS)

Stage II - 1 Year Progression Free Survival (PFS)

+4 more

Side effects data

From 2014 Phase 3 trial • 42 Patients • NCT01621672

68%

Grade 1 Hypoalbuminemia

52%

Grade 1 Thrombocytopenia

36%

Grade 2 Leukopenia

32%

Grade 1 Anemia

28%

Grade 1 Creatinine increase

24%

Grade 1 SGPT (ALT) increase

20%

Grade 1 Hypokalemia

20%

Grade 1 Hyperglycemia

20%

Grade 2 Sensory/Neuropathy

20%

Grade 1 SGOT (AST) increase

16%

Grade 1 Bilirubin increase

12%

Grade 2 Hypocalcemia

12%

Grade 1 Diarrhea

12%

Grade 4 Leukopenia

12%

Grade 1 Alkaline phosphatase increase

12%

Grade 1 Cough

Grade 2 Hypophosphatemia

Grade 2 Creatinine increase

Grade 3 Anemia

Grade 3 Gait/ walking

Grade 2 Diarrhea

Grade 2 Hypothyroidism

Grade 1 Hyponatremia

Grade 1 Joint

Grade 1 Sensory/Neuropathy

Grade 2 Upper Back

Grade 4 Thrombocyopenia

Grade 2 Hypoalbuminemia

Grade 1 Rhinitis

Grade 1 Fatigue

Grade 3 CNS Ischemia

Grade 3 Dysphagia

Grade 3 Skin Rash/desquamation

Grade 3 Hypokalemia

Grade 3 Hypophosphatemia

Grade 3 Sensory/Neuropathy

Grade 3 Extremity/limb

Grade 4 Hypocalcemia

Grade 3 Mood alteration

Grade 4 Neutropenia/granulocytopenia

Grade 3 Allergic reaction/Hypersensitivity

100%

80%

60%

40%

20%

Study treatment Arm

Revlimid

Observation

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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: Revlimid (Lenalidomide) in CombinationExperimental Treatment1 Intervention

Study of Lenalidomide in Combination with Rituximab, Ifosphamide, Etoposide, and Carboplatin (RICE-R) as Salvage Therapy with Single Agent Lenalidomide as Maintenance Therapy Post-Autologous Stem Cell Transplantation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

FDA approved

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