Lenalidomide Plus Rituximab for Indolent Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00695786
First received: June 10, 2008
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

The goal of this clinical research study is to learn if revlimid (lenalidomide) in combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma can control the disease. The safety of this combination will also be studied.


Condition Intervention Phase
Lymphoma
Drug: Lenalidomide
Drug: Rituximab
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: A Phase II Study of Revlimid in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-Hodgkin's Lymphoma (NHL)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants with Overall Response (OR) [ Time Frame: Assessed at end of 3 cycles (cycle is 28 days) ] [ Designated as safety issue: No ]
    Overall Response (OR) is defined as a Complete Response (CR) or Partial Response (PR) by International Workshop Response Criteria for Non-Hodgkin's Lymphoma.


Estimated Enrollment: 155
Study Start Date: June 2008
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide + Rituximab

Lenalidomide 20 mg by mouth (PO) daily on days 1 - 21 followed by 7 days rest (28 day cycle). Following cycle 3, if patients fail to show a response (partial or complete) the dose will be increased to 25mg/day.

Schedule B: Lenalidomide will be administered orally at 20 mg total daily dose on days 2 to 22 of a 28 day cycle in patients with follicular lymphoma. Following cycle 3, if patients fail to show a response (partial or complete) the dose will be increased to 25mg/day. Patients with a diagnosis of small lymphocytic lymphoma (SLL) will begin at a dose of 10 mg total daily on days 2 to 22 of a 28 day cycle. This dose will be escalated by 5mg every 28 days up to 20mg if no toxicity is encountered. If no response is observed by cycle 3, the dose will be increased to 25 mg.

Rituximab 375 mg/m^2 by vein over 4-8 Hours on day 1 of cycles 1-12 in schedule A, and day 1, 8,15, and 22 of cycle 1 and on day 1 of every subsequent cycle in schedule B.

Drug: Lenalidomide

20 mg by mouth (PO) daily on days 1 - 21 followed by 7 days rest (28 day cycle). Following cycle 3, if patients fail to show a response (partial or complete) the dose will be increased to 25mg/day.

Schedule B: Lenalidomide will be administered orally at 20 mg total daily dose on days 2 to 22 of a 28 day cycle in patients with follicular lymphoma. Following cycle 3, if patients fail to show a response (partial or complete) the dose will be increased to 25mg/day. Patients with a diagnosis of small lymphocytic lymphoma (SLL) will begin at a dose of 10 mg total daily on days 2 to 22 of a 28 day cycle. This dose will be escalated by 5mg every 28 days up to 20mg if no toxicity is encountered. If no response is observed by cycle 3, the dose will be increased to 25 mg.

Other Names:
  • Revlimid
  • CC-5013
Drug: Rituximab
375 mg/m^2 by vein over 4-8 Hours on day 1 of cycles 1-12 in schedule A, and day 1, 8,15, and 22 of cycle 1 and on day 1 of every subsequent cycle in schedule B.
Other Name: Rituxan

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  2. Age >/= 18 at the time of signing the informed consent form.
  3. Able to adhere to the study visit schedule and other protocol requirements.
  4. Untreated indolent non-Hodgkin's lymphoma stage III-IV including small lymphocytic lymphoma, marginal zone lymphoma, grade 1 or 2 follicular lymphoma. (prior radiation for localized disease allowed).
  5. At least one measurable lesion according to the International workshop standardized response criteria for non-Hodgkin's lymphomas (IWG) greater than 1.5cm.
  6. ECOG performance status of </= 2 at study entry.
  7. 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.
  8. 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, or localized prostate cancer treated with curative intent.
  9. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
  10. 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.
  11. 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.
  12. 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:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or breast feeding females.
  3. 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.
  4. Use of any chemotherapy or experimental therapy within 28 days of enrollment.
  5. Known hypersensitivity to thalidomide.
  6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  7. Any prior use of lenalidomide.
  8. Concurrent use of other anti-cancer agents or experimental treatments.
  9. Known positive for HIV or infectious hepatitis type B or C. (Hepatitis B core antibody can be positive if Hep B surface antigen is negative and no HBV DNA in blood, indicating a cleared infection.)
  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: NCT00695786

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00695786     History of Changes
Other Study ID Numbers: 2008-0042, NCI-2010-01028
Study First Received: June 10, 2008
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

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

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 October 19, 2014