Trial of Bendamustine, Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)

NCT00864942 | Completed Phase 1 DMC

• 2 other identifiers: RV-CLL-NHL-PI-3562008-186
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for subjects with a B-cell lymphoid malignancy (lymphoma) or chronic lymphocytic leukemia (CLL) that has come back after or did not get better with previous treatment. The purpose of this study is to find out the highest dose of lenalidomide that can be given together with bendamustine and rituximab. The study will also look what effects the combination of lenalidomide and bendamustine and the combination of lenalidomide, bendamustine and rituximab will have on patients and their disease.

Conditions

Chronic Lymphocytic Leukemia; Non-Hodgkin's Lymphoma

Keywords

CLL; NHL; lymphoma

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose

  2 years

• Dose limiting toxicity

  2 years

• Recommended Phase II dose

  2 years

Secondary Outcomes (3)

• overall safety profile

  2 years

• Plasma pharmacokinetics

  2 years

• Preliminary antitumor activity

  2 years

Study Arms (4)

BL-NHL

EXPERIMENTAL

Bendamustine and lenalidomide for NHL

Drug: BL-NHL

BLR-CLL

EXPERIMENTAL

Bendamustine, lenalidomide, rituximab for CLL

Drug: BLR-CLL

BLR-NHL

EXPERIMENTAL

Bendamustine, lenalidomide, and rituximab for NHL

Drug: BLR-NHL

BL-CLL

EXPERIMENTAL

bendamustine and lenalidomide in patients with CLL

Drug: bendamustine and lenalidomide

Interventions

bendamustine and lenalidomide DRUG

Lenalidomide is given daily orally for one week followed by bendamustine HCL 90 mg/m2 IV over 30 to 60 minutes on days 1 and 2 in combination with lenalidomide, given orally, in dose-escalating cohorts. After a maximum of 6 cycles of combination therapy with bendamustine and lenalidomide, lenalidomide monotherapy is continued for an additional 6 cycles as tolerated or until disease progression.

Also known as: Bendamustine HCL, Treanda, Revlimid

BL-CLL

BL-NHL DRUG

Bendamustine HCL 90 mg/m2 given intravenously over 30 to 60 minutes on days 1 and 2 in combination with lenalidomide, given orally, in dose-escalating cohorts. After a maximum of 6 cycles of combination therapy with bendamustine and lenalidomide, lenalidomide monotherapy is continued for an additional 6 cycles as tolerated or until disease progression.

Also known as: Bendamustine HCL, Treanda, Revlimid

BL-NHL

BLR-CLL DRUG

Lenalidomide is given orally for 7 days followed by rituximab 375 mg/m2 on day 1 in addition to bendamustine 90 mg/m2 intravenously over 30-60 minutes on days 1 and 2 and lenalidomide orally daily every 28 days for a total of 6 cycles. After 6 cycles of bendamustine, lenalidomide and rituximab, lenalidomide monotherapy is administered as continued therapy for an additional 6 cycles as tolerated or until disease progression.

Also known as: Bendamustine HCL, Treanda, Revlimid, Rituxan

BLR-CLL

BLR-NHL DRUG

Rituximab 375 mg/m2 is given on day 1 on day 1 in addition to bendamustine 90 mg/m2 intravenously over 30-60 minutes on days 1 and 2 and lenalidomide orally daily every 28 days for a total of 6 cycles. After 6 cycles of bendamustine, lenalidomide and rituximab, lenalidomide monotherapy is administered as continued therapy for an additional 6 cycles as tolerated or until disease progression.

Also known as: Bendamustine HCL, Treanda, Revlimid, Rituxan

BLR-NHL

Eligibility Criteria

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

You may qualify if:

• Documented relapsed or refractory B-cell NHL; CD-20 positive tumor. Indolent NHL: follicular B-cell lymphoma, diffuse small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, transformed aggressive lymphomas, mantle cell lymphoma and chronic lymphocytic leukemia
• Maximum of 6 prior chemotherapy regimens. Prior rituximab is allowed.
• Bidimensionally measurable disease
• ECOG performance status 0-2
• Absolute neutrophil count \>/= 1000 and platelet count \>/= 50,000
• Serum creatinine \</= 1.5 mg/dL
• Adequate hepatic function
• Estimated life expectancy of at least 3 months
• All study participants must be registered into the mandatory RevAssist program and be willing and able to comply with the requirements of RevAssist
• Able to take aspirin 81 mg daily as prophylactic anticoagulation

You may not qualify if:

• Chemotherapy or immunotherapy within 3 weeks prior to entering study or failure to recover from adverse events due to any agents administered previously
• Use of investigational agents within 28 days of study
• Hematopoietic growth factors within 14 days of study
• History of prior high dose chemotherapy with allogeneic stem cell support
• History of prior radioimmunotherapy \</= 1 year
• Concurrent treatment with therapeutic doses of systemic steroids
• Pregnant or lactating female subjects
• Concurrent, active malignancy other than lymphoma or CLL
• Primary CNS lymphoma
• Patients with a prior diagnosis of lymphoma active in the CNS are eligible only if CNS has been treated, and they are neurologically stable with no progressive symptoms off steroids and anti-convulsants
• Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of study objectives
• Hypersensitivity to murine proteins or to any component of rituximab
• Known positive for HIV or infectious hepatitis type C; hepatitis type B that is active and uncontrolled
• Hypersensitivity to mannitol
• Evidence of laboratory tumor lysis syndrome by Cairo-Bishop criteria

Sponsors & Collaborators

• Georgetown University: lead
• Celgene Corporation: collaborator
• Cephalon: collaborator

Study Sites (1)

Georgetown University Hospital/Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma

Interventions

Bendamustine Hydrochloride; Lenalidomide; Rituximab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bruce D Cheson, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 19, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 13, 2015

Record last verified: 2014-06

Locations

US (1)