Clinical trial · Interventional
Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma
NCT02701673CI-TRIAL-00022016withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to find the highest tolerable dose of belinostat that can be given in combination with azacitidine, gemcitabine, busulfan, and melphalan to patients who are scheduled to have a stem cell transplant. If you have diffuse large B-cell lymphoma (DLBCL), you will also receive 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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Belinostat | Drug | Belinostat | ALIAS |
| Busulfan | Drug | Busulfan | ALIAS |
| Caphosol | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Glutamine | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Pyridoxine | Drug | — | UNRESOLVED |
| Stem Cell Transplant | Procedure |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Belinostat/Gem/Bu/Mel + AutoSCT
- description
- Busulfan "test dose" administered by vein on Day -10. Test dose of 32 mg/m2 based on actual body weight. Busulfan pharmacokinetics performed with the test dose and the first dose on Day -8. Doses on Days -6 and -5 subsequently adjusted to target an area under curve (AUC) of 4,000 microMol.min-1. Caphosol oral rinses 30 mL four times a day used from Day -8. Oral Glutamine, 15 g swished, gargled and swallowed four times a day starting on Day -8. Pyridoxine 100 mg by vein or mouth three times a day staring on Day -1. Starting dose of Belinostat 100 mg/ m2/day by vein on Day -9 through Day -2. Azacitidine 15 mg/m2/day by vein on Day -9 through Day -2. Participants with cluster of differentiation antigen 20 (CD20+) tumors receive Rituximab 375 mg/m2 by vein on Day -9. Gemcitabine 75 mg/m2 by vein administered as a loading dose followed by prolonged infusion on Days -8 and -3. Melphalan 60 mg/m2/d by vein on Day -2. Stem cell transplant by vein given on Day 0.
- interventionNames
- Drug: Busulfan
- Drug: Caphosol
- Drug: Glutamine
- Drug: Pyridoxine
- Drug: Belinostat
- Drug: Azacitidine
- Drug: Gemcitabine
- Drug: Melphalan
- Procedure: Stem Cell Transplant
Primary outcomes (1)
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: 2. 1. DLBCL with one of the following: 2.1.1. Primary refractory (no CR to 1st line). 2.1.2. High-risk relapse (CR1 \<6 months, secondary IPI \>1, high LDH). 2.1.3. Refractory relapse: No response (SD or PD) to \>/= 1 line of salvage. 2.2. Hodgkin's with one of the following: 2.2.1. Primary refractory (no CR to 1st line or PD within 3 months). 2.2.2. High-risk relapse (CR1 \<1 year, extranodal relapse, B symptoms). 2.2.3. Refractory relapse: No response (SD or PD) to \>/= 1 line of salvage. 2.3. T-NHL with one of the following: 2.3.1. Primary refractory (\</= CR to 1st line or relapse within 6 months). 2.3.2. Nonresponsive (SD/PD) to \>/= 1 line of salvage. 2.4. Burkitt's or lymphoblastic lymphoma with one of the following: 2.4.1. Primary refractory (\</= CR to 1st line or relapse within 6 months). 2.4.2. Refractory to at least 1 line of salvage (SD/PD). 3. Adequate renal function, as defined by estimated serum creatinine clearance \>/= 50 ml/min and/or serum creatinine \</= 1.8 mg/dL. 4. Adequate hepatic function (SGOT and/or serum glutamate pyruvate transaminase (SGPT) \</= 3 x upper limit of normal (ULN); bilirubin and ALP \</= 2 x ULN. 5. 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%. 6. Adequate cardiac function with left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease. 7. PS \<2. 8. Negative Beta human chorionic gonadotropin (HCG) in woman with child-bearing potential. Exclusion Criteria: 1. Grade \>/= 3 non-hematologic toxicity from previous 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 enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.