A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL) (PATH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01034163
First received: December 15, 2009
Last updated: May 27, 2016
Last verified: May 2016

December 15, 2009
May 27, 2016
June 2010
May 2012   (final data collection date for primary outcome measure)
Number of Participants With Adverse Events [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
Safety monitoring was conducted throughout the study.
To compare the disease free survival (DFS) in patients with HL after achieving a complete response following AHSCT with HDT who are treated with panobinostat versus those who receive placebo based on investigator's review of radiological images. [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01034163 on ClinicalTrials.gov Archive Site
Not Provided
  • To compare OS for the two arms [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • To estimate and compare the rate of relapse (RoR) at 6, 12, and 24 months from randomization for the two arms [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • To characterize the safety and tolerability of panobinostat Exploratory [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • To assess the safety and tolerability of panobinostat [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • To explore the relationship of Pharmacokinetics-pharmacodynamics (PK-PD) (safety and efficacy) in patients with HL following AHSCT [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL)
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma Who Are at Risk for Relapse After High Dose Chemotherapy and Autologous Stem Cell Transplant (ASCT)
The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from the original protocol as of an amendment. The original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. An amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). Therefore, the study was completed as per this amendment. No secondary objectives were included for this trial from the amendment; this was a change from the original protocol.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hodgkin's Lymphoma
  • Drug: Panobinostat
    Other Name: LBH589
  • Drug: Placebo
    Placebo
  • Experimental: Panobinostat (PAN)
    Participants received 45 mg orally 3 times a week (TIW), every other week (QOW),
    Intervention: Drug: Panobinostat
  • Placebo Comparator: Placebo
    Participants received matching placebo to PAN TIW, QOW.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient age is greater than or equal to 18 years
  2. Patient has a history of histologically confirmed classical HL (i.e. Nodular sclerosing (NSHL), Mixed-cellularity (MCHL), Lymphocyte-rich (LRHL), Lymphocyte depleted (LDHL))
  3. Patient has achieved a complete response by CT/MRI scan within 9 weeks (± 1 week) from the day of their first autologous peripheral blood/ bone marrow stem cell transfusion (AHSCT) following HDT. Complete response is defined as:

    Normalization of all nodes and lesions compared to pre-transplant scan performed prior to salvage therapy for relapse. Any residual abnormal masses on the post transplant CT/MRI must be metabolically inactive on a PET scan.

  4. Patient has at least one of the following factors that places them at risk for relapse:

    • Primary refractory disease (including relapse in ≤ 3 months of completion of 1st line treatment)
    • First relapse >3 but <12 months from last dose of 1st line treatment
    • Multiple relapses (prior to transplant)
    • Stage III/IV disease (at relapse, prior to transplant)
    • Hemoglobin <10.5 gm/dL (at relapse, prior to transplant)

Exclusion Criteria:

Patient has been treated with allogeneic transplant 2. Patient has received any anti-lymphoma therapy after AHSCT including but not limited to:

  • chemotherapy prior to start of study
  • biologic immunotherapy including monoclonal antibodies or experimental therapy prior to start of study
  • radiation therapy 3. Patient has not recovered from reversible toxicity due to any prior therapies (e.g. returned to baseline or Grade ≤1) except for hematological laboratory parameters Note: Patient does not meet this criteria if the toxicity is stable and irreversible, and there is no evidence that panobinostat causes a similar toxicity 4. Patient has received prior treatment with DAC inhibitors including panobinostat
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Brazil,   Canada,   France,   Germany,   Israel,   Italy,   Netherlands,   New Zealand,   Poland,   Russian Federation,   Singapore
Spain
 
NCT01034163
CLBH589E2301, 2009-014846-26
Yes
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP