Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma

NCT00784927 | Completed Phase 2 Results DMC

• 4 other identifiers: MC0882P30CA015083RV-NHL-PI-033608-001485
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with rituximab, cyclophosphamide, and dexamethasone may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab, cyclophosphamide, and dexamethasone works in treating patients with previously untreated low-grade non-Hodgkin lymphoma.

Conditions

Lymphoma

Keywords

stage I grade 1 follicular lymphoma; contiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 1 follicular lymphoma; stage III grade 1 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage I small lymphocytic lymphoma; contiguous stage II small lymphocytic lymphoma; noncontiguous stage II small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma; Waldenstrom macroglobulinemia; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; stage I marginal zone lymphoma; contiguous stage II marginal zone lymphoma; noncontiguous stage II marginal zone lymphoma; stage III marginal zone lymphoma; stage IV marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

• Assessment of Tumor Response

  The proportion of responses was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients. Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed.

  Up to 1 year from registration.

Secondary Outcomes (4)

• Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia).

  Up to 1 year from registration.

• Survival Time

  Up to 1 year from registration.

• Progression-free Survival Time

  Up to 1 year from registration.

• Time to Treatment Failure

  Up to 1 year from registration.

Study Arms (1)

Treatment

EXPERIMENTAL

Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles: 375 mg/m\^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m\^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22.

Biological: rituximab; Drug: cyclophosphamide; Drug: dexamethasone; Drug: lenalidomide

Interventions

rituximab BIOLOGICAL

Treatment

cyclophosphamide DRUG

Treatment

dexamethasone DRUG

Treatment

lenalidomide DRUG

Treatment

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed symptomatic non-Hodgkin lymphoma by biopsy within the past 6 months * Any of the following subtypes allowed: * Grade 1 or 2 lymphoma * Small lymphocytic lymphoma * Marginal zone lymphoma * Lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia \[WM\]) * Previously untreated disease that, in the investigator's opinion, requires treatment * Measurable disease by CT or MRI scans with lymph nodes ≥ 2.0 cm in ≥ 1 dimension * WM patients without lymphadenopathy must meet the following criteria: * More than 10% lymphocytes, lymphoplasmacytic cells, or plasma cells on a bone marrow aspirate/biopsy * Quantitative Immunoglobulin M ≥ 400 mg/dL NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,400/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 2.0 mg/dL * Total or direct bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception at least 28 days prior to, during, and for 28 days after completion of study therapy * Able to take acetylsalicylic acid (ASA) 325 mg/day as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin) * No known hypersensitivity to thalidomide * No development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situations that would limit compliance with study requirements * No myocardial infarction within the past 6 months * No other active malignancy requiring treatment, except for localized nonmelanomatous skin cancer or any cancer that, in the judgement of the investigator, has been treated with curative intent and will not interfere with the study treatment plan and response assessment * No co-morbid systemic illnesses or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into the study or would interfere significantly with the proper assessment of safety and toxicity of study treatment * No known positivity for HIV or infectious hepatitis A, B, or C * No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent * Willing to return to Mayo Clinic enrolling institution for follow up * Registered into the RevAssist® program and willing and able to comply with the requirements of RevAssist® PRIOR CONCURRENT THERAPY: * No prior lenalidomide * No prior irradiation to ≥ 25% of the bone marrow * More than 28 days since prior experimental drug or therapy * No concurrent radiotherapy, chemotherapy, or immunotherapy * No other concurrent anticancer agents or treatments, including thalidomide or investigational agents

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell; Waldenstrom Macroglobulinemia; Lymphoma, B-Cell, Marginal Zone

Interventions

Rituximab; Cyclophosphamide; Dexamethasone; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Craig B. Reeder, MD
• Organization: Mayo Clinic Arizona

Reeder.Craig@mayo.edu

Study Officials

• Craig B Reeder, MD

  Mayo Clinic

  STUDY CHAIR

• Thomas E. Witzig, MD

  Mayo Clinic

  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 1, 2008
• First Posted: November 4, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2016
• Last Updated: October 7, 2016
• Results First Posted: February 8, 2016

Record last verified: 2016-08

Locations

US (2)