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A Phase II Efficacy Study of MK-4827 in Patients With Mantle Cell Lymphoma

Phase 2
18 Years
Not Enrolling
Lymphoma, Mantle-Cell

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Trial Information

A Phase II Efficacy Study of MK-4827 in Patients With Mantle Cell Lymphoma

Inclusion Criteria

Inclusion Criteria :

- Participant must have a diagnosis of MCL that has relapsed after at least one prior
chemotherapy regimen or for which the participant has refused standard therapy

- Participant has measureable disease defined by lymphadenopathy, organomegaly, bone
marrow involvement and/or circulating lymphoma cells. At least one lesion must be > 2
cm in the longest diameter and measurable in 2 perpendicular dimensions

- Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative
Oncology Group (ECOG) Performance Scale

- Female participants of child-bearing potential agree to use two approved
contraceptive methods or remain abstinent throughout the study

- Male participants agree to use an adequate method of contraception throughout the

- Participant has no history of prior cancer except certain cervical, skin, or prostate
cancers, or has undergone potentially curative therapy with no recurrence for five
years, or is deemed at low risk for recurrence

- Participant has not had any platelet or red blood cell transfusions or colony
stimulating factor support during the month prior to treatment

- Participant has a pre-study diagnostic formalin fixed paraffin-embedded tumor tissue
sample available

Exclusion Criteria :

- Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks
of screening

- Participant has a history of central nervous system (CNS) lymphoma

- Participant requires the use of corticosteroids

- Participant is pregnant, breastfeeding, or expecting to conceive or father children
during the study

- Participant is known to be human immunodeficiency virus (HIV)-positive

- Participant has a history of Hepatitis B or C

Type of Study:


Study Design:

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

Outcome Measure:

Number of participants who have a complete response (CR) or partial response (PR) during the study

Outcome Time Frame:

Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

August 2013

Related Keywords:

  • Lymphoma
  • Mantle-Cell
  • Poly (ADP-ribose) polymerase (PARP) inhibitor
  • Lymphoma
  • Lymphoma, Mantle-Cell