Trial · NCT00742027
Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma
NCT00742027, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma. Trials, record NCT00742027. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00742027
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma
- NCT number
- NCT00742027
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 129 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Classical Hodgkin's Lymphoma
- Interventions
- Panobinostat
- First posted
- 2008-08-27
- Last updated
- 2021-07-28
- Other registries' IDs
- eudract:2008-003016-35
- Results first posted
- 2021-06-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria | From the start of the treatment of last participant up to 32 weeks | ORR was number of participants with best overall disease response of complete response(CR)/partial response(PR).Best overall disease response was best disease response recorded from start of treatment until disease progression/recurrence.CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation. |
| Secondary | Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI) | From start of treatment until progression/recurrence or start of a new cancer therapy (up to approximately 5 years) | Best overall radiological response (CT/MRI) was recorded from start of treatment until progression/ recurrence. CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation. |
| Secondary | Time To Overall Disease Response in Responders | From the start of treatment up to approximately 5 years | Time to overall disease response (CR or PR) was defined as the time from the date of randomization/start of treatment to the date of first documented disease response (PR or CR). Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study as per Investigator's assessment. |
| Secondary | Duration of Overall Disease Response | From the start of treatment up to approximately 5 years | Duration of overall response (CR or PR) was defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to lymphoma. Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study. |
| Secondary | Progression Free Survival (PFS) | From the start of treatment up to approximately 5 years | Progression-free survival (PFS) was defined as the time from the date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a participant has not had an event, progression-free survival was censored at the date of the last adequate assessment. |
| Secondary | The Overall Survival (OS) | Baseline to date of death from any cause (up to approximately 5 years) | OS was the duration from date of randomization to date of death from any cause. If a participant has not had an event, overall survival was censored at the date of the last adequate assessment. |
| Secondary | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat | Up to approximately 5 years | An AE is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) occurring after signing the informed consent even if the event is not considered to be related to the study drug(s). SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality. |
| Secondary | Maximum Observed Concentration (Cmax) of Panobinostat | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose | |
| Secondary | The Time to Reach Maximum Plasma Concentration (Tmax) of Panobinostat | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose | |
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for Panobinostat | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria | From the start of the treatment of last participant up to 32 weeks | Full analysis set (FAS) included all participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI) | From start of treatment until progression/recurrence or start of a new cancer therapy (up to approximately 5 years) | FAS included all participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Time To Overall Disease Response in Responders | From the start of treatment up to approximately 5 years | FAS included all participants who received at least one dose of study drug. Participants who were responders among those who were had relapsed/refractory classical Hodgkin's lymphoma were evaluated for this outcome measure. Time to overall disease response was calculated by Kaplan-Meier estimation. | weeks | MEDIAN |
| SECONDARY | Duration of Overall Disease Response | From the start of treatment up to approximately 5 years | FAS included all participants who received at least one dose of study drug. Participants who were responders among those who were had relapsed/refractory classical Hodgkin's lymphoma were evaluated for this outcome measure. Time to overall disease response was calculated by Kaplan-Meier estimation. | weeks | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From the start of treatment up to approximately 5 years | FAS included all participants who received at least one dose of study drug. | months | MEDIAN |
| SECONDARY | The Overall Survival (OS) | Baseline to date of death from any cause (up to approximately 5 years) | FAS included all participants who received at least one dose of study drug. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat | Up to approximately 5 years | Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment. | percentage of participants | NUMBER |
| SECONDARY | Maximum Observed Concentration (Cmax) of Panobinostat | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose | Pharmacokinetic set (PK) included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile. | nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | The Time to Reach Maximum Plasma Concentration (Tmax) of Panobinostat | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose | PK population included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile. | hours | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for Panobinostat | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose | PK population included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile. | hour*nanograms per milliliter (h.ng/mL) | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria | Panobinostat | Complete Response | 5 | Participants | |
| Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria | Panobinostat | Partial Response | 30 | Participants | |
| Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria | Panobinostat | Stable Disease | 71 | Participants | |
| Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria | Panobinostat | Progressive Disease | 14 | Participants | |
| Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria | Panobinostat | Unknown | 9 | Participants | |
| Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI) | Panobinostat | Complete Response | 0.8 | percentage of participants | |
| Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI) | Panobinostat | Partial Response | 20.9 | percentage of participants | |
| Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI) | Panobinostat | Stable Disease | 56.6 | percentage of participants | |
| Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI) | Panobinostat | Progressive Disease | 15.5 | percentage of participants | |
| Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI) | Panobinostat | Unknown | 6.2 | percentage of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Panobinostat | 129 | |
| Overall Study | COMPLETED | Panobinostat | 0 | |
| Overall Study | NOT COMPLETED | Panobinostat | 129 |
Source ClinicalTrials.gov
Adverse events190
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 | Anaemia | Blood and lymphatic system disorders | Panobinostat | 52 | 129 | |
| other | Leukopenia | Blood and lymphatic system disorders | Panobinostat | 16 | 129 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Panobinostat | 5 | 129 | |
| other | Neutropenia | Blood and lymphatic system disorders | Panobinostat | 36 | 129 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Panobinostat | 109 | 129 | |
| other | Bradycardia | Cardiac disorders | Panobinostat | 4 | 129 | |
| other | Palpitations | Cardiac disorders | Panobinostat | 4 | 129 | |
| other | Sinus tachycardia | Cardiac disorders | Panobinostat | 7 | 129 | |
| other | Tachycardia | Cardiac disorders | Panobinostat | 8 | 129 | |
| other | Hypothyroidism | Endocrine disorders | Panobinostat | 20 | 129 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panobinostat | ||
| Total, other adverse events | Panobinostat | 129 | 129 |
| Total, serious adverse events | Panobinostat | 51 | 129 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00742027
GET https://conductscience.org/api/trials/v1/NCT00742027/results?page=2