Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, Davis
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01316523
First received: February 4, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

Lenalidomide has been shown to have single agent activity in indolent Non-Hodgkin's Lymphoma. It is approved for the treatment of multiple myeloma and myelodysplastic syndrome.

Rituximab is effective as a single agent and in combination with chemotherapy for indolent Non-Hodgkin's Lymphoma.

The purpose of this study is to see how well giving lenalidomide together with rituximab works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma.

Lenalidomide will taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, unacceptable side effects or after twelve cycles if the patient is responding well.

Rituximab 375 mg/m2/wk x 4 weeks will begin on Day 15 of cycle 1. After 4 cycles of therapy, if patients respond well to treatment, patients will receive a second course of Rituximab.

Blood samples will be collected to assess how the immune system is functioning.


Condition Intervention Phase
Non Hodgkin's Lymphoma
Drug: Rituximab
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Response rate to treatment [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Responses will be assessed by the Revised Working Group Response Criteria for Malignant Lymphoma. A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease.


Secondary Outcome Measures:
  • Time to progression [ Time Frame: Up to two years. ] [ Designated as safety issue: No ]
    Time to progression will be measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression, or the date of death if the patient dies due to causes other than disease progression

  • Overall survival [ Time Frame: Up to two years. ] [ Designated as safety issue: No ]
    Overall survival wil be measured as the time from start of treatment to the date of death or the last date the patient was known to be alive

  • Tolerability [ Time Frame: Up to two years. ] [ Designated as safety issue: Yes ]
    Tolerability means the type, frequency, severity and relationship of adverse events to study treatment based on the National Cancer Institute Common Toxicity Criteria Version 4.0

  • Duration of response from start of therapy [ Time Frame: Up to two years. ] [ Designated as safety issue: No ]

    The duration of response is measured from the time measurement criteria are met for complete response/partial response(whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

    The duration of response is measured from the time measurement criteria are first met for complete response until the first date that recurrent disease is objectively documented.



Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide + Rituximab
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Drug: Rituximab
Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
Other Name: Rituxan
Drug: Lenalidomide
Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
Other Name: Revlimid

  Eligibility

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

Inclusion Criteria:

  1. All patients must be informed of the investigative nature of the clinical trial and given written informed consent in accordance with institutional and federal guidelines.
  2. Age greater than or equal to 18 years at the time of signing the informed consent form.
  3. Able to adhere to the study visit schedule and other protocol requirements.
  4. Previously untreated, histologically confirmed indolent lymphoma including follicle cell lymphoma, WHO classification, grade I or II, and marginal zone lymphoma. Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies. Fine needle aspirates are not acceptable.
  5. At least one measurable lesion according to the International Working Group Response criteria for lymphomas. There must be measurable lymphadenopathy to follow with serial exam and/or imaging.
  6. Submission of original biopsy for review by local staff hematopathologist.
  7. ECOG performance status of 0 -2 at study entry.
  8. No major organ dysfunction with laboratory test results within these ranges:

    • Absolute neutrophil count greater than or equal to 1000 /uL
    • Platelet count greater than or equal to 75 x 109/L
    • Total bilirubin less than or equal to 2.0 mg/dL.
    • HIV negative
    • Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula. See section below, "Dosing Regimen", regarding lenalidomide dose adjustment for calculated creatinine clearance ≥ 30ml/min and < 60ml/min.
  9. Life expectancy of greater than 3 months.
  10. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  11. Disease free of prior malignancies for greater than or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
  12. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients who are intolerant to aspirin may use low molecular weight heparin).
  13. Must be able to swallow lenalidomide capsules.

Exclusion Criteria:

  1. Any prior treatment for Non-Hodgkin's Lymphoma.
  2. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  3. Pregnant or breast-feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
  4. 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.
  5. Use of any other experimental drug or therapy within 28 days of baseline.
  6. Known hypersensitivity to thalidomide or rituximab.
  7. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  8. Any prior use of lenalidomide.
  9. Concurrent use of other anti-cancer agents or treatments.
  10. Known positive for HIV
  11. Known active hepatitis, type A, B or C.
  12. Evidence for CNS metastatic disease
  13. Subjects with ≥ Grade 2 neuropathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316523

Contacts
Contact: Corinne Turrell 916 734 3089

Locations
United States, California
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Joseph Tuscano, MD         
Sutter Pacific Medical Foundation Recruiting
Santa Rosa, California, United States, 95403
Contact: Beth Davis    707-576-4738    davismb1@sutterhealth.org   
Principal Investigator: Eric Dean, MD         
Sponsors and Collaborators
University of California, Davis
Celgene Corporation
Investigators
Principal Investigator: Joseph Tuscano, MD University of California, Davis
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01316523     History of Changes
Other Study ID Numbers: UCDCC#224, RV_PI_NHL_0488
Study First Received: February 4, 2011
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Davis:
Lenalidomide
Rituximab
untreated indolent Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 22, 2014