Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffuse Large B-Cell Lymphoma of the ABC Subtype

• Status: Terminated
• Trial end date: 2019-04-08
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination with vorinostat, gemcitabine, busulfan, and melphalan, with a stem cell transplant, and with or without rituximab. Researchers also want to learn about the safety and effectiveness of this combination.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Celgene Corporation
• Treatments: BB 1101; Busulfan; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Enoxaparin; Gemcitabine; Lenalidomide; Melphalan; Pyridoxal; Pyridoxine; Rituximab; Thalidomide; Vitamin B 6; Vorinostat

Criteria

Inclusion Criteria:

1. Age 15-65

2. Patients with ABC (determined by immunohistochemistry using the Hans algorithmI) DLBCL with primary refractory disease, relapse <12 months after initial therapy, secondary International Prognostic Index (IPI) >1, less than partial response to salvage treatment or exposure to >3 salvage regimens

3. Adequate renal function, as defined by an estimated serum creatinine clearance >/= 50 ml/min (MDRD method) and/or serum creatinine

4. Adequate hepatic function (SGOT and/or SGPT

5. Adequate pulmonary function with FEV1, FVC and DLCO (corrected for Hgb) >/= 50%

6. Adequate cardiac function with left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease

7. ECOG performance status <2

8. Negative Beta HCG in woman with child-bearing potential

9. All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of the REMS program.

10. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program.

Exclusion Criteria:

1. Grade >/= 3 non-hematologic toxicity from previous therapy that has not resolved to

2. Prior whole brain irradiation

3. Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/= 10,000 copies/mL, or >/= 2,000 IU/mL)

4. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology

5. Active infection requiring parenteral antibiotics

6. HIV infection, unless receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts

7. Radiation therapy in the month prior to enrollment

8. History of arterial thromboembolic events in the past 3 months and of venous thromboembolic events in the past month

9. History of hypersensitivity of lenalidomide or thalidomide