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NCT01169636 · ClinicalTrials.gov registry record · Phase 1
Panobinostat Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Compared With ICE For Relapsed Hodgkin Lymphoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT01169636: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01169636 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01169636, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
Objectives: Primary objective: * Phase-I: To determine the maximal tolerated dose (MTD) of panobinostat (LBH589) + Ifosfamide + Mesna, Carboplatin and Etoposide (ICE) combination * Randomized Phase-II: To estimate the complete response (CR) rate in patients with relapsed and refractory classical Hodgkins Lymphoma (HL) receiving ICE versus PANOBINOSTAT plus ICE therapy Secondary Objectives: * To assess the safety and tolerability of the novel combination of PANOBINOSTAT (LBH589) plus ICE versus ICE in patients with relapsed and refractory HL * To estimate the overall response rate (CR + partial response PR) * To estimate the success rate of stem cell collection in patients eligible for stem cell transplant * To estimate the percentage of patients who subsequently undergo autologous stem cell transplantation (ASCT) * To estimate the event free survival (EFS) at 1 year after randomization * To determine pretreatment expression level of histone deacetylases (HDAC1), HDAC2, and pSTAT3 and Signal transducer and activator of transcription protein (pSTAT6) by Immunohistochemistry (IHC) and correlate the results with treatment response
Primary Outcome
Maximum Tolerated Dose (MTD) of Panobinostat + ICE
Interventions
- DRUG Carboplatin
- DRUG Mesna
- DRUG Etoposide
- DRUG Ifosfamide
- DRUG Panobinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2011-01-31 |
| Est. Completion | 2017-05-17 |
| Phase | Phase 1 |
What the finished NCT01169636 record still lists
NCT01169636 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01169636 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01169636 about?
NCT01169636 is a clinical study titled "Panobinostat Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Compared With ICE For Relapsed Hodgkin Lymphoma". Objectives: Primary objective: * Phase-I: To determine the maximal tolerated dose (MTD) of panobinostat (LBH589) + Ifosfamide + Mesna, Carboplatin and Etoposide (ICE) combination * Randomized Phase-II: To estimate the complete response (CR) rate in patients with relapsed and refractory classical H...
What is the current status of trial NCT01169636?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2011-01-31. Estimated completion is 2017-05-17.
What interventions are being tested in trial NCT01169636?
The interventions under investigation include: Carboplatin (DRUG), Mesna (DRUG), Etoposide (DRUG), Ifosfamide (DRUG), Panobinostat (DRUG).
Who is sponsoring clinical trial NCT01169636?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01169636's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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