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An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma

Phase 1
18 Years
Open (Enrolling)
Follicular Lymphoma

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Trial Information

An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma

Inclusion 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants experiencing clinical and laboratory adverse events (AEs) during combination therapy

Outcome 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)

Safety Issue:



Russia: Ministry of Health of the Russian Federation

Study ID:




Start Date:

August 2011

Completion Date:

February 2015

Related Keywords:

  • Follicular Lymphoma
  • Lymphoma
  • Lymphoma, Follicular