Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2008 |
Phase 2 Trial of Lenalidomide (Revlimid)-Dexamethasone + Rituximab in Recurrent Small B-Cell Non-Hodgkin Lymphomas (NHL) Resistant to Rituximab
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.
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.
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
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
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