Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodg… (NCT00742027) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma
United States129 participantsStarted 2008-09-16
Plain-language summary
This study evaluated the efficacy of oral panobinostat in participants with refractory/relapsed classical Hodgkins lymphoma (HL) who have received prior treatment with high dose chemotherapy and autologous stem cell transplant. Safety of panobinostat also was assessed. Other markers that may correlate with efficacy or safety were explored.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant age is ≥ 18 years.
✓. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
✓. Participant has a history of classical Hodgkin's Lymphoma (HL) (i.e. Nodular sclerosing, Mixed-cellularity, Lymphocyte-rich, Lymphocyte depleted).
✓. Participant has progressive disease after receiving high dose chemotherapy with autologous hematopoietic stem cell transplant (AHSCT).
✓. Participant has at least one site of measurable nodal disease at baseline ≥ 2.0 centimeter (cm) in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by computed tomography (CT) scan (magnetic resonance imaging \[MRI\] is allowed only if CT scan can not be performed).
✓. Participant has the following laboratory values (labs may be repeated, if needed, to obtain acceptable values before screen fail):
✓. Clinically euthyroid. Note: Participants are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.
✓. Written informed consent was obtained from the participant prior to any study-specific screening procedures.
Exclusion criteria
✕. Participant has a history of prior treatment with a deacetylase (DAC) inhibitor including panobinostat.
✕. Participant will need valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat treatment.
What they're measuring
1
Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria
Timeframe: From the start of the treatment of last participant up to 32 weeks
✕. Participant has been treated with monoclonal antibody therapy (e.g., rituximab or anti CD-30 antibody, etc.) within 4 weeks of start of study treatment.
✕. Participant has received chemotherapy or any investigational drug or undergone major surgery ≤ 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to ≤ grade 1.
✕. Participant has been treated with \> 5 prior systemic lines of treatment (see Post-text supplement 2 for definitions and examples).
✕. Participant has received prior radiation therapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to start of study treatment or whose side effects of such therapy have not resolved to ≤ grade 1.
✕. Participant is using any anti-cancer therapy concomitantly.
✕. Participant treated with allogeneic hematopoietic stem cell transplant who is currently on or has received immunosuppressive therapy within 90 days prior to start of screening and/or have ≥ Grade 2 graft versus host disease (GvHD).