Clinical Trials

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

Location:

Trial status:

Closed

Why is this study being done?

The purpose of this phase III study is to evaluate the efficacy of orally-administered panobinostat in reducing the risk of relapse in patients with classical Hodgkin's Lymphoma who achieved a complete response following high-dose chemotherapy (HDT) with Autologous stem cell transplant(AHSCT).

Who is eligible to participate?

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

Other protocol-defined inclusion/exclusion criteria may apply

Last updated: 05/07/2013

NCT ID: NCT01034163

IRB Number:10-002605