Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the RICE therapy and again after transplant as maintenance. To improve over all outcome and survival.

Hypothesis is that combining lenalidomide with standard of care (RICE) may increase overall response rate thus increasing the number of patients able to proceed with autologous stem cell transplant. This in turn may translate into improved overall survival and progression free survival.

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

Details

• Lead Sponsor: Hackensack Meridian Health; Hackensack University Medical Center
• Collaborator: Celgene Corporation
• Treatments: Ifosfamide; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:Understand and voluntarily sign an informed consent form.

1. Age 18 years at the time of signing the informed consent form.

2. Able to adhere to the study visit schedule and other protocol requirements.

3. Histologically confirmed diffuse large B cell lymphoma

4. Relapsed or refractory after one prior therapeutic treatment for DLBCL. Refractory is defined as patients received adequate prior treatment and did not respond during treatment or progressed within 90 days of last treatment.

5. Measurable disease with at least on bidimensional lymph node or tumor mass >1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT

6. Histologically confirmed involvement of the bone marrow by DLBCL on the bone marrow biopsy without other measurable disease

7. Eligible for autologous stem cell transplant

8. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least two weeks prior to treatment in this study.

9. ECOG performance status of 2 at study entry (see Appendix B).

10. Laboratory test results within these ranges:

• Absolute neutrophil count >1000 /mm³

• Platelet count > 50,000/mm³ (unless bone marrow is heavily infiltrated with underlying disease (50% or more) Calculated creatinine clearance of ≥ 60 mL/min by Cockroft-Gault formula (Appendix E) for patients enrolled into the phase I portion of the study (Stage I). Calculated creatinine clearance of ≥ 30 mL/min by Cockroft-Gault formula for patients enrolled into the phase II portion of the study (Stage II). See Section 5.4.2 for lenalidomide dose adjustment for calculated creatinine clearance > 30ml/min and < 60ml/min.

• Total bilirubin < 1.5 x ULN.

• AST (SGOT) and ALT (SGPT) < 3 x ULN.

11. 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.

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

13. 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 starting 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 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. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

14. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).

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Exclusion Criteria: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

1. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).

2. 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.

3. Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities.

4. Use of any other experimental drug or therapy within 28 days of baseline.

5. Known hypersensitivity to thalidomide.

6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.

7. Concurrent use of other nonprotocol anti-cancer agents or treatments.

8. Known positive for HIV or active infectious hepatitis, type B or C.

9. Refusal of autologous stem cell transplant.

10. Patients with active central nervous system involvement based on clinical evaluation. Previously treated CNS involvement that has remained asymptomatic for more than ninety days is allowed if no active CNS disease present as confirmed by MRI or/and lumbar puncture.

11. Concurrent uncontrolled serious medical ort psychiatric conditions likely to interfere with participation in this clinical study, as judged by investigator.

12. Prior Lenalidomide exposure for more than 28 days.

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