Clinical trial · Interventional
Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffuse Large B-Cell Lymphoma of the ABC Subtype
NCT02589145CI-TRIAL-00042268terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed due to very slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Caphosol | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Enoxaparin | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Glutamine | Drug | — | UNRESOLVED |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Palifermin | Drug |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide + Vorinostat/Gem/Bu/Mel + AutoSCT
- description
- Vorinostat and lenalidomide administered orally at the same time within 1 hour before the daily dose of chemotherapy. Gemcitabine administered as a loading dose of 75 mg/m2 followed by infusion on days -8 and -3. Busulfan test dose administered as outpatient before admission, or as inpatient on day -10. The "test dose" of 32 mg/m2 based on actual body weight. Doses of days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Melphalan administered at 60 mg/m2 on days -3 and -2. Patients with CD20+ tumors receive rituximab 375 mg/m2 on day -9 in the AM as an inpatient. Dexamethasone 8 mg by vein twice a day from day -8 to day -2. Caphosol oral rinses 30 mL four times a day used from day -8. Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on day -8. Pyridoxine 100 mg by vein or mouth three times a day from day -1. Enoxaparin 40 mg subcutaneously daily from admission until platelet count drops below 50,000/mm3.
- interventionNames
- Drug: Lenalidomide
- Drug: Vorinostat
- Drug: Gemcitabine
- Drug: Busulfan
- Drug: Melphalan
- Drug: Rituximab
- Drug: Dexamethasone
- Drug: Caphosol
- Drug: Glutamine
- Drug: Pyridoxine
- Drug: Enoxaparin
- Procedure: Stem Cell Transplant
- Drug: Palifermin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 \</= 1.8 mg/dL 4. Adequate hepatic function (SGOT and/or SGPT \</= 3 x ULN; bilirubin and ALP \</= 2 x ULN 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 \</= G1 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
References
Publications (0)
Data not yet available
No reference posted for this study.