Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL

NCT01241734 | Completed Phase 1 Results DMC

• 2 other identifiers: Pro00001132RV-DLBCL-PI-0463
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse Large B cell Lymphoma

Outcome Measures

Primary Outcomes (3)

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

  Determine the maximum tolerated dose (MTD) of lenalidomide when given in combination with rituximab, Ifosfamide, etoposide, and carboplatin (RICE) for the treatment of DLBCL patients in first relapse by incidence of dose-limiting toxicity (DLT) for Stage I Patients Only

  Cycle 1 of Treatment (28 Days)

• Stage II - Overall Response Rate

  Rate of overall response by incidence of Complete Response, Partial Response, and Stable Disease per Modified International Working Group (IWG) response criteria for patients enrolled in Stage II

  After 2 Cycles of Treatment (28 Day Cycles)

• Stage III - Overall Response Rate

  Rate of overall response by incidence of Complete Response, Partial Response, and Stable Disease per Modified International Working Group (IWG) response criteria for patients enrolled in Stage III

  After 2 Cycles of Treatment (28 Day Cycles)

Secondary Outcomes (7)

• Stage I - Dose Limiting Toxicity Incidence Rate

  Cycle 1 of Treatment (28 Days)

• Stage II - 1 Year Progression Free Survival (PFS)

  Up to 1 Year

• Stage II - 2 Year Progression Free Survival (PFS)

  Up to 2 Years

• Stage II - 1 Year Overall Survival (OS)

  Up to 1 Year

• Stage II - 2 Year Overall Survival (OS)

  Up to 2 years

Study Arms (1)

Revlimid (Lenalidomide) in Combination

EXPERIMENTAL

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

Drug: Revlimid

Interventions

Revlimid DRUG

Stage I: Cohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7 Stage II: RICE + Lenalidomide at the MTD days 1-7 Stage III: Lenalidomide 25mg days 1-21 every 28 days

Also known as: Lenalidomide

Revlimid (Lenalidomide) in Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Histologically confirmed diffuse large B cell lymphoma
• Relapsed or refractory after one prior therapeutic treatment for DLBCL. Refractory is defined as patients received adequate prior treatment and did not respond during treatment or progressed within 90 days of last treatment.
• Measurable disease with at least on bidimensional lymph node or tumor mass \>1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT
• Histologically confirmed involvement of the bone marrow by DLBCL on the bone marrow biopsy without other measurable disease
• Eligible for autologous stem cell transplant
• All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least two weeks prior to treatment in this study.
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 at study entry (see Appendix B).
• Laboratory test results within these ranges:
• Absolute neutrophil count \>1000 /mm³
• Platelet count \> 50,000/mm³ (unless bone marrow is heavily infiltrated with underlying disease (50% or more) Calculated creatinine clearance of ≥ 60 mL/min by Cockroft-Gault formula (Appendix E) for patients enrolled into the phase I portion of the study (Stage I). Calculated creatinine clearance of ≥ 30 mL/min by Cockroft-Gault formula for patients enrolled into the phase II portion of the study (Stage II). See Section 5.4.2 for lenalidomide dose adjustment for calculated creatinine clearance \> 30ml/min and \< 60ml/min.
• Total bilirubin \< 1.5 x Upper Limit of Normal (ULN).
• Aspartate Aminotransferase (SGOT) and Alanine Aminotransferase (SGPT) \< 3 x ULN.
• Disease free of prior malignancies for \> 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.

You may not qualify if:

• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Concurrent use of other nonprotocol anti-cancer agents or treatments.
• Known positive for HIV or active infectious hepatitis, type B or C.
• Refusal of autologous stem cell transplant.
• Patients with active central nervous system involvement based on clinical evaluation. Previously treated central nervous system (CNS) involvement that has remained asymptomatic for more than ninety days is allowed if no active CNS disease present as confirmed by MRI or/and lumbar puncture.
• Concurrent uncontrolled serious medical ort psychiatric conditions likely to interfere with participation in this clinical study, as judged by investigator.
• Prior Lenalidomide exposure for more than 28 days.

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• Celgene Corporation: collaborator

Study Sites (2)

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level. A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.

Results Point of Contact

• Title: Joshua Zenreich
• Organization: Hackensack Meridan Health

joshua.zenreich@hmhn.org

5519964248

Study Officials

• Tatyana Feldman, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: September 22, 2015
• Last Updated: April 8, 2026
• Results First Posted: September 14, 2023

Record last verified: 2026-03

Locations

US (2)