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A Phase II Study of MK0683 in Patients With Relapsed / Refractory Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL)


Phase 2
20 Years
74 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase II Study of MK0683 in Patients With Relapsed / Refractory Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL)


Inclusion Criteria:



- Patient Is 20 To 74 Years Old

- Patient Has An Histopathologically Confirmed Fl, Or Other Indolent B-Nhl Or Mcl (Only
Relapsed / Refractory Fl Can Be Included Outside Japan.)

- Patient Has At Least One Measurable Lesion By Ct Scan Which Is Defined By Cheson's
1999 Criteria

- Patient Has Received At Least 1 But Up To 4 Prior Chemotherapeutic Regimen, 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.

- Patient Must Have Adequate Organ And Marrow function

Exclusion Criteria:

- Patient Who Has Undergone Allogenic Transplant Treatment Or Autologous Stem Cell
Transplant Within 6 Months

- Patient With Other Active Malignancies Or Central Neurological Infiltration With
Lymphoma

- Patient With Severe Hepatic Insufficiency

- Patient With History Of Allergic Reactions Attributed To Any Component Of MK0683

- Patient Who Is Known To Be HIV Antibody-, Hbv Antigen- Or Hcv Antibody-Positive

- Patient Who Has Undergone Prior/Concomitant Treatment With MK0683 Or Other Hdac
Inhibitors

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Response Rate

Outcome Time Frame:

21 Months

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

2009_570

NCT ID:

NCT00875056

Start Date:

April 2009

Completion Date:

January 2014

Related Keywords:

  • Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Mantle-Cell

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