Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

NCT00096044 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000391767RPCI-I-18103CELGENE-RV-CLL-PI-005
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia.

Conditions

Leukemia

Keywords

refractory chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months

  Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count \>1500/μL; platelet count \>100,000/μL; untransfused hemoglobin concentration \>11.0g/dL; lymphocyte count \<4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.

  at 6 Months

Secondary Outcomes (5)

• Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab

  5 years

• Number of Participants With Adverse Events on Single Agent CC-5013

  1 year

• Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab

  Up to 30 days from last date of institution of combination therapy of CC-5013+Rituximab.

• Time to Progression for Single Agent CC-5013

  5 years

• Time to Progression for the Combination Therapy of CC-5013+Rituximab

  Every month up to 6 months and every 3 months thereafter up to 5 years

Study Arms (1)

Oral Lenalidomide

EXPERIMENTAL

Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

Biological: rituximab; Drug: lenalidomide

Interventions

rituximab BIOLOGICAL

IV

Oral Lenalidomide

lenalidomide DRUG

Oral

Oral Lenalidomide

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of chronic lymphocytic leukemia (CLL) by flow cytometry * Relapsed or refractory disease * Measurable disease, defined by 1 of the following criteria: * Absolute lymphocyte count ≥ 5,000/mm\^3 * Measurable lymphadenopathy or organomegaly * Received ≥ 1 prior therapy for CLL PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 30,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present) Renal * Creatinine ≤ 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation * No known hypersensitivity to thalidomide * No erythema nodosum characterized by a desquamating rash after prior thalidomide or similar drug administration * No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins * No serious medical condition or laboratory abnormality that would preclude study participation * No psychiatric illness that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * No prior lenalidomide (CC-5013) * No concurrent thalidomide Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * At least 4 weeks since prior therapy for CLL * At least 28 days since prior experimental drug or therapy * No other concurrent anticancer therapies * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Celgene: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; Lenalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 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

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Kelvin Lee, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: March 1, 2004
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-06

Locations

US (1)