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Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Mayo Clinic Scottsdale
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00784927
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: cyclophosphamide
Drug: dexamethasone
Drug: lenalidomide
Drug: rituximab
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Cyclophosphamide Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Rituximab Lenalidomide CC 5013
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase 2 Study of Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone (LR-CD) for Untreated Low Grade Non-Hodgkin Lymphoma Requiring Therapy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of confirmed complete responses [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival time [ Designated as safety issue: No ]
  • Progression-free survival time [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]

Estimated Enrollment: 31
Study Start Date: November 2008
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To assess tumor response to lenalidomide, rituximab, cyclophosphamide, and dexamethasone in patients with symptomatic previously untreated low-grade non-Hodgkin lymphoma.

Secondary

  • To describe the adverse event profile of this regimen.
  • To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure associated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral lenalidomide once daily on days 1-21, rituximab IV on day 1, oral cyclophosphamide once daily on days 1, 8, and 15, and oral dexamethasone once daily on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784927

Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
Sponsors and Collaborators
Mayo Clinic Scottsdale
Investigators
Study Chair: Craig B. Reeder, MD Mayo Clinic Scottsdale
Investigator: Thomas E. Witzig, MD Mayo Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Mayo Clinic Scottsdale ( Clinical Trials Office )
Study ID Numbers: CDR0000617788, MAYO-MC0882, CELGENE-RV-NHL-PI-0336, MAYO-08-001485
Study First Received: November 1, 2008
Last Updated: December 31, 2008
ClinicalTrials.gov Identifier: NCT00784927  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Dexamethasone
Chronic lymphocytic leukemia
Immunoproliferative Disorders
Rituximab
Leukemia, B-cell, chronic
Lenalidomide
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Cyclophosphamide
Lymphoma, B-Cell
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Leukemia, Lymphocytic, Chronic, B-Cell
B-cell lymphomas
Waldenstrom macroglobulinemia
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Dexamethasone acetate
Follicular lymphoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Hormones
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Autonomic Agents
Therapeutic Uses
Myeloablative Agonists
Peripheral Nervous System Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Central Nervous System Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009