Trial · NCT01169636
Panobinostat Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Compared With ICE For Relapsed Hodgkin Lymphoma
NCT01169636, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2021-01-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Panobinostat Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Compared With ICE For Relapsed Hodgkin Lymphoma. Trials, record NCT01169636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01169636
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Panobinostat Plus Ifosfamide, Carboplatin, and Etoposide (ICE) Compared With ICE For Relapsed Hodgkin Lymphoma
- NCT number
- NCT01169636
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Hodgkin's Lymphoma
- Interventions
- Panobinostat, Ifosfamide, Mesna, Carboplatin, Etoposide, Pegfilgrastim
- First posted
- 2010-07-26
- Last updated
- 2021-01-06
- Results first posted
- 2021-01-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Panobinostat + ICE | From first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose, up to 6 years | Maximum Tolerated Dose (MTD) of Panobinostat + ICE |
| Primary | Number of Participants With Complete Remission (CR) | Assessed after 3 cycles of ICE (2 months) | Will be assessed by Kaplan-Meier methods. |
| Secondary | Percentage of Participants With Failure Free Survival (FFS) | 16 months | FFS duration was calculated from date of study entry to date of progression or death or change of therapy, whichever came first. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Panobinostat + ICE | From first dose of panobinostat (or chemotherapy, in the arm of ICE alone) until 30 days after last dose, up to 6 years | mg | NUMBER | |
| PRIMARY | Number of Participants With Complete Remission (CR) | Assessed after 3 cycles of ICE (2 months) | Per protocol all Phase I Cohorts are analyzed as a single group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Failure Free Survival (FFS) | 16 months | Per protocol all Phase I Cohorts are analyzed as a single group. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Panobinostat + ICE | Phase I: Panobinostat + ICE (Maximal Tolerated Dose (MTD) | 30 | mg | ||
| Number of Participants With Complete Remission (CR) | Phase I: Panobinostat + ICE (Maximal Tolerated Dose (MTD) | Complete Response | 21 | Participants | |
| Number of Participants With Complete Remission (CR) | Phase II: Standard of Care (ICE) | Complete Response | 8 | Participants | |
| Number of Participants With Complete Remission (CR) | Phase II Panobinostat + ICE | Complete Response | 9 | Participants | |
| Number of Participants With Complete Remission (CR) | Phase I: Panobinostat + ICE (Maximal Tolerated Dose (MTD) | Partial Response | 4 | Participants | |
| Number of Participants With Complete Remission (CR) | Phase II: Standard of Care (ICE) | Partial Response | 1 | Participants | |
| Number of Participants With Complete Remission (CR) | Phase II Panobinostat + ICE | Partial Response | 0 | Participants | |
| Number of Participants With Complete Remission (CR) | Phase I: Panobinostat + ICE (Maximal Tolerated Dose (MTD) | Stable Disease | 2 | Participants | |
| Number of Participants With Complete Remission (CR) | Phase II: Standard of Care (ICE) | Stable Disease | 2 | Participants | |
| Number of Participants With Complete Remission (CR) | Phase II Panobinostat + ICE | Stable Disease | 2 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I: Panobinostat + ICE 10 mg | 3 | |
| Overall Study | STARTED | Phase I: Panobinostat + ICE 20 mg | 6 | |
| Overall Study | STARTED | Phase I: Panobinostat + ICE 30 mg | 20 | |
| Overall Study | STARTED | Phase II: Standard of Care (ICE) | 13 | |
| Overall Study | STARTED | Phase II: Panobinostat + ICE | 14 | |
| Overall Study | COMPLETED | Phase I: Panobinostat + ICE 10 mg | 3 | |
| Overall Study | COMPLETED | Phase I: Panobinostat + ICE 20 mg | 6 | |
| Overall Study | COMPLETED | Phase I: Panobinostat + ICE 30 mg | 17 | |
| Overall Study | COMPLETED | Phase II: Standard of Care (ICE) | 12 | |
| Overall Study | COMPLETED | Phase II: Panobinostat + ICE | 11 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Phase I: Panobinostat + ICE 10 mg | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Phase I: Panobinostat + ICE 20 mg | 1 | 6 | |
| other | Nausea | Gastrointestinal disorders | Phase I: Panobinostat + ICE 30 mg | 19 | 20 | |
| other | Nausea | Gastrointestinal disorders | Phase II: Standard of Care (ICE) | 12 | 12 | |
| other | Nausea | Gastrointestinal disorders | Phase II: Panobinostat+ICE | 9 | 11 | |
| other | Constipation | Gastrointestinal disorders | Phase I: Panobinostat + ICE 10 mg | 0 | 3 | |
| other | Constipation | Gastrointestinal disorders | Phase I: Panobinostat + ICE 20 mg | 0 | 6 | |
| other | Constipation | Gastrointestinal disorders | Phase I: Panobinostat + ICE 30 mg | 3 | 20 | |
| other | Constipation | Gastrointestinal disorders | Phase II: Standard of Care (ICE) | 3 | 12 | |
| other | Constipation | Gastrointestinal disorders | Phase II: Panobinostat+ICE | 0 | 11 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: Panobinostat + ICE 10 mg | 0 | 3 |
| Total, all-cause mortality | Phase I: Panobinostat + ICE 20 mg | 0 | 6 |
| Total, all-cause mortality | Phase I: Panobinostat + ICE 30 mg | 0 | 20 |
| Total, all-cause mortality | Phase II: Standard of Care (ICE) | 0 | 12 |
| Total, all-cause mortality | Phase II: Panobinostat+ICE | 0 | 11 |
| Total, other adverse events | Phase I: Panobinostat + ICE 10 mg | 0 | 3 |
| Total, other adverse events | Phase I: Panobinostat + ICE 20 mg | 1 | 6 |
| Total, other adverse events | Phase I: Panobinostat + ICE 30 mg | 19 | 20 |
| Total, other adverse events | Phase II: Standard of Care (ICE) | 12 | 12 |
| Total, other adverse events | Phase II: Panobinostat+ICE | 11 | 11 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01169636
GET https://conductscience.org/api/trials/v1/NCT01169636/events?page=2