Clinical trial · Interventional
Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma
Phase I, Prospective, Open-label, Multi-centric, Dose Finding Trial of Combination of IGEV and Panobinostat Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma
NCT01884428CI-TRIAL-00013596unknownPhase 1ClinicalTrials.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)
study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose
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 |
|---|---|---|---|
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| panobinostat | Drug | Panobinostat | ALIAS |
| Prednisolone | Drug | Prednisolone | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Panobinostat + IGEV
- description
- Panobinostat + IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine, Prednisolone)
- interventionNames
- Drug: panobinostat
- Drug: Ifosfamide
- Drug: Gemcitabine
- Drug: Vinorelbine
- Drug: Prednisolone
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) or the recommended phase II dose defined as the highest dosage cohort at which no more than one of six patients will experience a DLT in the first treatment cycle.
- timeFrame
- 3 weeks
Secondary outcomes (6)
- measure
- DLT
- timeFrame
- 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of relapsed or refractory classical HL * Measurable disease * One or two prior systemic lines of treatment * PS(ECOG) 0-2 * Absence of bone marrow infiltration * Adequate laboratory values for bone marrow, liver and renal functionality Exclusion Criteria: * prior or concurrent treatment with a DAC inhibitor including panobinostat * valproic acid therapy for any medical condition during the study or within 5 days prior to the first panobinostat treatment * previous autologous hematopoietic stem cell transplant * other concurrent therapy intended to treat the primary cancer including chemotherapy, investigational or biologic agents or other antitumor agents * impaired cardiac function or unstable AF * known history of HIV seropositivity, chronic hepatitis, or other active viral infections * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection) * pregnant or breast feeding women
References
Publications (0)
Data not yet available
No reference posted for this study.