Clinical trial NCT00875056: Study of Vorinostat (MK-0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL), or Mantle Cell Lymphoma (MCL) Participants (MK-0683-103)
Official title: A Phase II Study of MK-0683 in Patients With Relapsed / Refractory Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants received the same drug regimen but were allocated to groups based on disease type.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of vorinostat (MK-0683) in participants with relapsed and/or refractory follicular lymphoma. The exploratory purpose of this study is to evaluate efficacy of MK-0683 in participants with relapsed/refractory non-FL indolent B-NHL or relapsed/refractory MCL. The primary hypothesis is that MK-0683 will show efficacy in relapsed/refractory FL patients as measured by the Overall Response Rate.


Eligibility criteria: Inclusion Criteria:

* Participant has an histopathologically confirmed follicular lymphoma (FL), or other indolent B-cell non-Hodgkin's lymphoma (B-NHL) or mantle cell lymphoma (MCL)

  * Only relapsed/refractory FL can be included outside Japan
* Participant has at least one measurable lesion by computerized tomography (CT) scan which is defined by Cheson's 1999 criteria
* Participant has received at least 1 but up to 4 prior chemotherapeutic regimens, the most recent therapy must have failed to induce a partial response, or there must be recurrence in case of the most recent therapy has shown complete response, or there must be relapse in case of the most recent therapy has shown partial response
* Life expectancy of \>4 months
* Participant must have adequate organ and marrow function
* Women of child bearing potential must be negative for pregnancy and agree to use effective contraceptive measures until 30 days after the last dose of MK-0683.
* Men must agree to use effective contraceptive measures until 6 months after the last dose of MK-0683

Exclusion Criteria:

* Participant has undergone allogenic transplant treatment or autologous stem cell transplant within 6 months
* Participant with other active malignancies or central neurological infiltration with lymphoma
* Participant with severe hepatic insufficiency
* Participant with history of allergic reactions attributed to any component of MK-0683
* Participant is known to be human immunodeficiency virus (HIV) antibody-, hepatitis B virus antigen- or hepatitis C virus antibody-positive
* Participant has undergone prior/concomitant treatment with MK-0683 or other histone deacetylase (HDAC) inhibitors

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 650 days
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 29 months
measure: Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event (AE)
timeFrame: Up to 536 days
Secondary outcomes:
measure: Time to Treatment Failure for Relapsed/Refractory FL
timeFrame: Up to 650 days
measure: Time to Response for Relapsed/Refractory FL
timeFrame: Up to 650 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Ogura M, Ando K, Suzuki T, Ishizawa K, Oh SY, Itoh K, Yamamoto K, Au WY, Tien HF, Matsuno Y, Terauchi T, Yamamoto K, Mori M, Tanaka Y, Shimamoto T, Tobinai K, Kim WS. A multicentre phase II study of vorinostat in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. Br J Haematol. 2014 Jun;165(6):768-76. doi: 10.1111/bjh.12819. Epub 2014 Mar 12.