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A Phase II Study of MK0457 in Patients With T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A Phase II Study of MK0457 in Patients With T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia


Inclusion Criteria:



- This study will evaluate MK0457 in patients with CML (chronic myelogenous leukemia)
and Ph+ALL (Philadelphia chromosome-positive acute lymphoblastic leukemia)

- Patients must have adequate organ function

- Patients must have documented T315I mutation

Exclusion Criteria:

- Patients within 3 months of allogeneic bone marrow transplant or not fully recovered
from previous anti-leukemia therapy

- Patients with uncontrolled congestive heart failure

- Patients with active or uncontrolled infection or active Hepatitis B or C

- Patients with known HIV positivity or AIDS related illness

- Patients with currently active second malignancy, other than non-melanoma skin
cancer.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

efficacy

Outcome Time Frame:

24 Months

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2006_551

NCT ID:

NCT00405054

Start Date:

December 2006

Completion Date:

June 2009

Related Keywords:

  • Leukemia
  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

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