Clinical trial · Interventional
Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Lymphoma
NCT02961816CI-TRIAL-00027109withdrawnPhase 2ClinicalTrials.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): Lack of funding
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn about the safety and effectiveness of the combination of panobinostat, gemcitabine, busulfan, and melphalan, either with or without rituximab, in patients who have non-Hodgkin's or Hodgkin's lymphoma and are receiving a stem cell transplant.
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 |
| G-CSF | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Glutamine | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Oral Cryotherapy (ice chips) | Other | — | UNRESOLVED |
| Palifermin | Drug | — |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A: Diffuse Large B-Cell Lymphoma
- description
- Palifermin on Days -13 to -11 and on Days 0, +1, and +2. Panobinostat daily from Day -9 to -2. Gemcitabine administered on Days -8 and -3. Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK. Melphalan on Days -3 and -2. Rituximab on Day -9 for participants with CD20+ tumors. Dexamethasone twice a day from Day -8 AM to Day -2 PM. 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 three times a day from Day -1. Stem cells administered by vein on Day 0. G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
- interventionNames
- Drug: Palifermin
- Drug: Panobinostat
- Drug: Gemcitabine
- Drug: Busulfan
- Drug: Melphalan
- Drug: Rituximab
- Drug: Dexamethasone
- Drug: Caphosol
- Drug: Glutamine
- Other: Oral Cryotherapy (ice chips)
- Drug: Pyridoxine
- Biological: Stem Cell Infusion
- Drug: G-CSF
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: DLBCL with one of the following: 1. Primary refractory (no CR to 1st line); 2. High-risk relapse (CR1 \<6 months, secondary IPI \>1 or high LDH); or, 3. Refractory relapse: No response (SD or PD) to \>/= 1 line of salvage. 3. Hodgkin's with one of the following: 1. Primary refractory (no CR to 1st line or PD within 3 months); 2. High-risk relapse (CR1 \<1 year, extranodal relapse or B symptoms); or, 3. Refractory relapse: No response (SD or PD) to \>/= 1 line of salvage. 4. T-NHL with one of the following: 1. Primary refractory (\</= CR to 1st line or relapse within 6 months); or, 2. Nonresponsive (SD/PD) to \>/= 1 line of salvage. 5. Adequate renal function, as defined by estimated serum creatinine clearance \>/= 50 ml/min and/or serum creatinine \</= 1.8 mg/dL 6. Adequate hepatic function (SGOT and/or serum glutamate pyruvate transaminase (SGPT) \</= 3 x upper limit of normal (ULN); bilirubin and ALP \</= 2 x ULN 7. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) (corrected for Hgb) \>/= 50% 8. Adequate cardiac function with left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease 9. PS \<2 10. Negative Beta human chorionic gonadotropin (HCG) in woman with child-bearing potential Exclusion Criteria: 1. Grade \>/= 3 non-hematologic toxicity from prior therapy that has not resolved to \</= G1 2. Prior whole brain irradiation 3. Corrected QT interval (QTc) longer than 500 ms 4. Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA \>/= 10,000 copies/mL, or \>/= 2,000 IU/mL) 5. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology 6. Active infection requiring parenteral antibiotics 7. HIV infection, unless receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts 8. Radiation therapy in the month prior to enroll
References
Publications (0)
Data not yet available
No reference posted for this study.