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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Leukemia, Myeloid, Acute; Lymphoblastic Leukemia, Acute

Treatments: Drug: SCH 727965; Drug: Gemtuzumab ozogamicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00798213

P04717

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 4 patient groups

Participants with AML randomized to SCH 727965

Experimental group

Treatment:

Drug: SCH 727965

Participants with AML randomized to gemtuzumab ozogamicin

Active Comparator group

Treatment:

Drug: Gemtuzumab ozogamicin

AML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin

Experimental group

Treatment:

Drug: SCH 727965

Participants with ALL treated with SCH 727965

Experimental group

Treatment:

Drug: SCH 727965