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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. 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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01169636
The ClinicalTrials.gov registry entry for NCT01169636 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01169636 reports 0 study locations.
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.
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