Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01370694
First received: May 18, 2011
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single agent, for participants with B-lymphocyte antigen cluster of differentiation 20 (CD20)-positive follicular lymphoma who have had no prior chemotherapy.


Condition Intervention Phase
Follicular Lymphoma
Drug: MK-8808
Drug: cyclophosphamide
Drug: vincristine
Drug: prednisolone
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants experiencing clinical and laboratory adverse events (AEs) during combination therapy [ Time Frame: From first dose (baseline) of CVP therapy up to 30 days post last dose (up to eight 21-day cycles of combination therapy) ] [ Designated as safety issue: Yes ]
  • Number of participants experiencing clinical and laboratory AEs during single agent maintenance with MK-8808 [ Time Frame: From first dose (baseline) of single agent maintenance therapy up to 30 days after the last dose (up to 2 years) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum concentration (C[max]) in plasma levels of MK-8808 when used in combination with CVP [ Time Frame: Day 1 of all CVP cycles (up to eight 21-day cycles) ] [ Designated as safety issue: No ]
  • C[max] in plasma levels of MK-8808 when used as single agent maintenance [ Time Frame: Day 1 of every other bimonthly single agent maintenance therapy cycle; or Day 1 of each 6-month single agent maintenance cycle, up to 2 years ] [ Designated as safety issue: No ]
  • Lowest concentration (C[trough]) of plasma levels of MK-8808 when used in combination with CVP [ Time Frame: Day 1 of all CVP cycles (up to eight 21-day cycles) ] [ Designated as safety issue: No ]
  • C[trough] of plasma levels of MK-8808 when used as single agent maintenance [ Time Frame: Day 1 of every other bimonthly single agent maintenance therapy cycle; or Day 1 of each 6-month single agent maintenance cycle, up to 2 years ] [ Designated as safety issue: No ]
  • Clinical response [ Time Frame: Before each cycle of CVP (baseline), every 3 to 4 months during maintenance therapy, and approximately one month after last dose of MK-8808, up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-8808 Combination therapy Drug: MK-8808
Intravenous (IV) infusion at a dose of 375 mg/m^2 on Day 1 of each 21-day combination therapy cycle; at 375 mg/m^2 administered approximately every 2 months for up to 2 years, beginning 8 weeks (2 months) afer the last dose of induction therapy.
Drug: cyclophosphamide
IV infusion, 750 mg/m^2, on Day 1 of each 21-day combination therapy cycle
Drug: vincristine
IV infusion, 1.4 mg/m^2 (max 2 mg), on Day 1 of each 21-day combination therapy cycle
Drug: prednisolone
40 mg/m^2,orally, on Days 1-5 of each 21-day combination therapy cycle
Experimental: MK-8808 Maintenance therapy (2 month cycle) Drug: MK-8808
Intravenous (IV) infusion at a dose of 375 mg/m^2 on Day 1 of each 21-day combination therapy cycle; at 375 mg/m^2 administered approximately every 2 months for up to 2 years, beginning 8 weeks (2 months) afer the last dose of induction therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Histological diagnosis of CD20-positive follicular lymphoma, Grade 1, 2, or 3a (World Health Organization [WHO] 2008 classification) based on an excisional or incisional lymph node biopsy or a bone marrow biopsy.
  • Ann Arbor Stage III or IV disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
  • Life expectancy >3 months with no expected need of immediate intervention to treat life-threatening complications.
  • Adequate organ function.
  • Participants must agree to use an adequate method of contraception starting with the first dose of study drug through 12 months (for females) or 90 days (for males) after the last dose of study drug.

Exclusion criteria:

  • Histological Grade 3b or with >50% diffuse architectural pattern.
  • Circulating malignant cells >25,000/mm^3
  • Presence or history of central nervous system (CNS) disease (either CNS lymphoma or lymphomatous meningitis).
  • Prior treatment with chemotherapy, rituximab, any other anti-CD20 compound, or any other type of anti-cancer compounds.
  • Radiotherapy within 2 months prior to Cycle 1 Day 1.
  • Current participation or has participated in a study with an investigational compound within 30 days prior to Cycle 1 Day 1.
  • Concomitant disease that requires continuous therapy with prednisone at doses >20 mg per day.
  • Any medical contraindication for prednisolone as being dosed in the CVP regimen.
  • Poorly controlled diabetes mellitus, as defined by institutional or local standards.
  • Grade >2 peripheral neuropathy.
  • Has one of the following:

    1. is human immunodeficiency virus (HIV)-positive
    2. is Hepatitis B surface antigen positive (HBsAg+) or is positive for antibodies to Hepatitis B core antigen (anti-HBcAg+)
    3. has antibodies to Hepatitis C virus
  • Has one or more of the following:

    1. Active tuberculosis based on institutional diagnostic criteria and local practice guidelines.
    2. Evidence of a tuberculosis infection based on a chest X-ray (CXR) or computed tomography (CT) scan performed within 3 months of dosing.
    3. History of a tuberculosis infection.
  • Major surgical procedure within 4 weeks prior to Cycle 1 Day 1.
  • Regular use (including "recreational" use) of any illicit drugs or recent history (within the last year) of drug or alcohol abuse or dependence.
  • Pregnant or breastfeeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01370694     History of Changes
Other Study ID Numbers: 8808-001, 2011-000386-13
Study First Received: May 18, 2011
Last Updated: July 18, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on August 26, 2014