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Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00783367
Recruitment Status : Active, not recruiting
First Posted : October 31, 2008
Last Update Posted : April 14, 2020
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
Pre-clinical data and recently published clinical data suggest a synergistic effect between lenalidomide and dexamethasone. We hypothesize that a combination of lenalidomide-dexamethasone can overcome rituximab resistance. To determine the response rate to lenalidomide and dexamethasone plus rituximab therapy in subjects with recurrent small B-cell non-Hodgkin lymphoma who have had lymphoma progression within 6 months of being treated with rituximab alone or with a rituximab-containing regimen, we propose initial treatment with both drugs for two 28-day treatment cycles (Part I). After response assessment following two cycles of lenalidomide-dexamethasone, patients will enter Part II of the study. In Part II, patients will receive lenalidomide-dexamethasone and rituximab to evaluate the potential reversal of rituximab resistance as measured by response to rituximab and progression-free survival following rituximab.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Marginal Zone B-Cell Lymphoma MALT Lymphoma Lymphoma of Mucosa-Associated Lymphoid Tissue Lymphoma, Small Lymphocytic Waldenstrom Macroglobulinemia Mantle-Cell Lymphoma Drug: Lenalidomide Drug: Dexamethasone Drug: Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Lenalidomide (Revlimid)-Dexamethasone + Rituximab in Recurrent Small B-Cell Non-Hodgkin Lymphomas (NHL) Resistant to Rituximab
Study Start Date : July 2008
Actual Primary Completion Date : November 14, 2012
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: Lenalidomide plus rituximab with dexamethasone
Lenalidomide-low dose dexamethasone plus rituximab
Drug: Lenalidomide
Lenalidomide: 10mg capsules, orally, once daily for each 28 day cycle for the duration of the study
Other Name: Revlimid (lenalidomide)

Drug: Dexamethasone
Dexamethasone: 8mg tablets, orally, once weekly on days 3, 10, 17, 24 of each 28 day cycle for the duration of the study;
Other Name: Decadron (dexamethasone)

Drug: Rituximab
Rituximab: 375mg/m2 IV (in the vein), once weekly on days 1, 8, 15, 22 during month 3 of therapy
Other Name: Rituxan (rituximab)

Primary Outcome Measures :
  1. Response rate to lenalidomide-dexamethasone + rituximab therapy in relapsed small B-cell lymphoma with rituximab resistance [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Time until progression after lenalidomide-dexamethasone + rituximab therapy in relapsed small B-cell lymphomas with rituximab resistance [ Time Frame: twelve months ]
  2. Compare the response rate for the previous rituximab-containing regimen to that obtained subsequently to lenalidomide-dexamethasone + rituximab therapy [ Time Frame: twelve months ]
  3. Determine the toxicity profile of lenalidomide-dexamethasone + rituximab therapy in patients who have received a previous rituximab-containing combination regimen [ Time Frame: every twenty-eight days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously treated, histologically confirmed follicular lymphoma (grade 1, 2, 3a), marginal zone lymphoma, small lymphocytic lymphoma with less than <5000 lymphocytes/mm3 or lymphoplasmacytic lymphoma with <3g/mL IgM, mantle cell lymphoma by WHO classification
  • Flow cytometry or immunohistochemistry must document CD20 antigen expression. Past documentation of CD20 antigen expression is admissible.
  • Subjects must have been treated with rituximab in combination with chemotherapy or as monotherapy and must have refractory or progressive disease <6 months from the first rituximab dose of previous rituximab containing regimen
  • At least 18 years of age
  • ECOG performance status 0-2
  • Measurable disease must be present on physical examination or imaging studies. Any tumor mass >2cm is considered measurable.
  • Lesions that are considered non-measurable, but assessable include the following: bone lesions, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, bone marrow
  • Patients with a history of intravenous drug abuse or any behavior associated with increased risk of HIV infection should be tested for exposure to the HIV virus
  • Understand and voluntarily sign an informed consent
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant of ASA may use warfarin or low molecular weight heparin)
  • Laboratory test results within these ranges: absolute neutrophil count greater than or equal to 1500/mm3; platelet count greater than or equal to 75,000/mm3; serum creatinine less than or equal to 2.0mg/dL; total bilirubin less than or equal to 1.5mg/dL (unless due to Gilbert's syndrome); AST (SGOT) and ALT (SGPT) less than or equal to 2.5 x ULN or less than or equal to 5 x ULN if hepatic metastases are present
  • Disease free of prior malignancies for greater than or equal to 5 years with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" 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 (prescriptions must be filled within 7 days) 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.

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from following study procedure
  • 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 other experimental drug or therapy within 28 days of baseline
  • 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
  • Known positivity for HIV or active infectious Hepatitis, type A, B, or C. Patients who test positive or who are known to be infected are not eligible due to an increased risk of infection with this regimen. HIV testing is not required for study entry, but is required if the patient is perceived to be at risk.
  • Known central nervous system involvement by lymphoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00783367

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United States, Pennsylvania
University of Pennsylvania; Abramson Cancer Center; Lymphoma Program
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
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Principal Investigator: Stephen J Schuster, MD University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT00783367    
Other Study ID Numbers: UPCC 02408
UPenn IRB#807684
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Celgene brand of lenalidomide
CD20 antibody, rituximab
Follicular Lymphoma
Marginal Zone B-Cell Lymphoma
Lymphoma, Small Lymphocytic
Waldenstrom Macroglobulinemia
Mantle-Cell Lymphoma
Antigens, CD20
resistantRefractory/progressive lymphoma less than 6 months from first rituximab dose of previous rituximab-containing regimen
Previously treated
Treated with rituximab
Additional relevant MeSH terms:
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Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Waldenstrom Macroglobulinemia
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, B-Cell
Leukemia, Lymphoid
Dexamethasone acetate
BB 1101