Clinical trial · Interventional

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

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

NCT01370694CI-TRIAL-00037640terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): The study was terminated for business reasons.

Summary

Brief summary (as posted)

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. The primary study hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a single agent.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Follicular Lymphoma	Follicular Lymphoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
MK-8808	Drug	Rituximab	ALIAS
prednisolone	Drug	Prednisolone	ALIAS
vincristine	Drug	Vincristine	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
MK-8808 Combination Therapy
description
Participants received MK-8808 375 mg/m\^2 intravenously (IV) + cyclophosphamide 750 mg/m\^2 IV + vincristine 1.4 mg/m\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
interventionNames
1. Drug: MK-8808
2. Drug: cyclophosphamide
3. Drug: vincristine
4. Drug: prednisolone

Primary outcomes (2)

measure
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy
timeFrame
From first dose of combination therapy up to 24 weeks
description
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.