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Lenalidomide Plus Rituximab for Indolent Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Celgene Corporation
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00695786
  Purpose

Primary Objective:

1. To evaluate the overall response rate of lenalidomide in combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma (NHL).

Secondary Study Objective:

1. To evaluate the toxicity of lenalidomide in combination with Rituximab in previously untreated indolent non-Hodgkin's lymphoma.

Primary Endpoint:

1. To determine the number of CR, and PR.

Secondary Endpoint:

1. Determine the type, frequency, severity, and relationship of adverse events to lenalidomide and rituximab.


Condition Intervention Phase
Lymphoma
Drug: Lenalidomide
Drug: Rituximab
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Rituximab Lenalidomide CC 5013
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Lenalidomide (Revlimid) in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-Hodgkin's Lymphoma (NHL)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To learn if lenalidomide in combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma can control the disease. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Lenalidomide + Rituximab
Drug: Lenalidomide
20 mg PO Daily x 21 Days
Drug: Rituximab
375 mg/m^2 IV Over 4-8 Hours

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form.
  • Age >/= 18 at the time of signing the informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Untreated indolent non-Hodgkin's lymphoma stage III-IV including small lymphocytic lymphoma, marginal zone lymphoma, grade 1 or 2 follicular lymphoma.
  • At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee criteria of greater than 1.5cm.
  • ECOG performance status of </= 2 at study entry.
  • Laboratory test results within these ranges: Absolute neutrophil count >/= 1.5 x 10^9/L; Platelet count >/=100 x 10^9/L; Serum creatinine </= 2.0 mg/dL; Total bilirubin </=1.5 mg/dL; AST (SGOT) and ALT (SGPT) </=2 x ULN or </=5 x ULN if hepatic metastases are present.
  • Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
  • All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 -14 days prior to and again within 24 hours of prescribing 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 4 weeks 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 female of child bearing potential even if they have had a successful vasectomy.
  • For patients with bulky disease (tumors >5cm) must be able to take aspirin (81 mg or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin.

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or breast feeding females.
  • 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.
  • Use of any chemotherapy or experimental therapy within 28 days of enrollment.
  • Known hypersensitivity to thalidomide.
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Any prior use of lenalidomide.
  • Concurrent use of other anti-cancer agents or experimental treatments.
  • Known positive for HIV or infectious hepatitis type B or C.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695786

Contacts
Contact: Felipe Samaniego, MD 713-792-2860

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Felipe Samaniego, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Felipe Samaniego, MD U.T.M.D. Anderson Cancer Center
  More Information

UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Felipe Samaniego, MD/Associate Professor )
Study ID Numbers: 2008-0042
Study First Received: June 10, 2008
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00695786  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Non-Hodgkin's Lymphoma
Lymphoma
Lenalidomide
Revlimid
Rituximab
Rituxan

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lenalidomide
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009