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A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid, Acute, Lymphoblastic Leukemia, Acute

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Trial Information

A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia


Inclusion Criteria:



- For participants with AML:

- Age >=60 years, either sex, any race.

- Diagnosis of CD33-positive AML by World Health Organization criteria.

- Must be in first or second relapse, or have primary refractory or refractory
disease at first salvage, and not be considered a candidate for transplant.

- Acute promyelocytic leukemia who has relapsed following treatment with both all
trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.

- For participants with ALL:

- Age >=18 years, either sex, any race.

- Diagnosis of ALL by World Health Organization criteria.

- Must be in first or second relapse, or have primary refractory or refractory
disease at first salvage, and not be considered a candidate for potentially
curative therapy.

- Eastern Cooperative Oncology group performance status of 0 or 1.

- Adequate hematologic, renal, and hepatic organ function and laboratory
parameters.

- Receiving treatment with hydroxyurea or leukapheresis to reduce elevated white
blood cell count to <=30 x 10^9 is eligible, provided hydroxyurea and
leukapheresis are discontinued at least 24 hours before initiation of study
drug.

Exclusion Criteria:

- Known central nervous system leukemia.

- Previous hematopoietic stem cell transplantation.

- Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.

- For AML, previous treatment with gemtuzumab ozogamicin.

- Known HIV infection.

- Known active hepatitis B or C.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL.

Outcome Time Frame:

Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months).

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

P04717

NCT ID:

NCT00798213

Start Date:

January 2009

Completion Date:

April 2010

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Lymphoblastic Leukemia, Acute
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Acute Disease

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