Maintenance Lenalidomide in Lymphoma

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to evaluate the overall safety of lenalidomide (also known as Revlimid) in patients with lymphoma, and to determine whether it is effective in preventing this disease from returning after stem cell transplant. This study will also determine the dose of lenalidomide that can be given without causing severe side effects. Lenalidomide has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of lymphoma. At least 28 people will be enrolled on this study at the University of Pennsylvania.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

SCREENING STEP A:

1. Able to understand and voluntarily sign the informed consent form.

2. Aged greater 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. Biopsy-proven diagnosis of lymphoma (including diffuse large B-cell, mantle cell, follicular, marginal zone, peripheral T cell, small lymphocytic lymphoma with large cell transformation, and Hodgkin lymphomas).

5. Completion of at least 2 cycles of salvage chemotherapy, with pre-ASCT PET/CT imaging showing PET positive residual lesion(s) (SUV greater than 2.5).

6. Disease free of other malignancies for greater or equal to 2 years with exception of basal cell and squamous cell carcinomas of the skin, or carcinoma in situ of the cervix or breast.

NOTE: Patients who successfully complete high dose-chemotherapy and ASCT will proceed to Screening Step B, provided that they achieve hematologic recovery within 100 days of ASCT (see below).

SCREENING STEP B (performed between days 28-100 post-ASCT):

1. Completion of high-dose chemotherapy with ASCT.

2. Hematologic recovery at 28-100 days after ASCT (defined as ANC greater or equal to 1,000 and platelet count greater or equal to 60,000).

3. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

4. ECOG performance status of less than or equal to 2 at study entry (see Appendix B).

5. Patients undergoing planned consolidative radiation therapy must be finished with the therapy by day 100 after ASCT.

6. 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 to 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (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. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

7. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (warfarin or low molecular weight heparin may be used for patients intolerant of aspirin or at the discretion of the treating physician).

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 (lactating females must agree not to breast feed while taking lenalidomide).

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 other experimental drug or therapy within 28 days of initiating treatment with lenalidomide.

5. Known hypersensitivity to thalidomide.

6. The development of erythema nodosum, a blistering or desquamating rash, while taking thalidomide or similar drugs.

7. Any prior use of lenalidomide.

8. Concurrent use of other anti-cancer agents or therapies during study treatment.

9. Known seropositive for or active viral infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.