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SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)

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ClinicalTrials.gov Identifier: NCT00798213
Recruitment Status : Terminated
First Posted : November 26, 2008
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Lymphoblastic Leukemia, Acute Drug: SCH 727965 Drug: Gemtuzumab ozogamicin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia
Study Start Date : January 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010


Arm Intervention/treatment
Experimental: Participants with AML randomized to SCH 727965 Drug: SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.

Active Comparator: Participants with AML randomized to gemtuzumab ozogamicin Drug: Gemtuzumab ozogamicin
Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.
Other Name: Mylotarg

Experimental: AML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin Drug: SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.

Experimental: Participants with ALL treated with SCH 727965 Drug: SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.




Primary Outcome Measures :
  1. Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL. [ Time Frame: Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months). ]
  2. Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator. [ Time Frame: Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months). ]

Secondary Outcome Measures :
  1. Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL. [ Time Frame: Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months). ]
  2. Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML. [ Time Frame: Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months). ]
  3. Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML. [ Time Frame: Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months). ]
  4. Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin [ Time Frame: Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months). ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00798213     History of Changes
Other Study ID Numbers: P04717
First Posted: November 26, 2008    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Gemtuzumab
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents