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

Primary Purpose

Leukemia, Myeloid, Acute, Lymphoblastic Leukemia, Acute

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SCH 727965

Gemtuzumab ozogamicin

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Participants with AML randomized to SCH 727965

Participants with AML randomized to gemtuzumab ozogamicin

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

Participants with ALL treated with SCH 727965

Arm Description

Outcomes

Primary Outcome Measures

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

Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator.

Secondary Outcome Measures

Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL.

Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML.

Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML.

Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin

Full Information

NCT ID

NCT00798213

First Posted

November 25, 2008

Last Updated

February 3, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00798213

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Terminated

Study Start Date

January 2009 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myeloid, Acute, Lymphoblastic Leukemia, Acute

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Participants with AML randomized to SCH 727965

Arm Type

Experimental

Arm Title

Participants with AML randomized to gemtuzumab ozogamicin

Arm Type

Active Comparator

Arm Title

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

Arm Type

Experimental

Arm Title

Participants with ALL treated with SCH 727965

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SCH 727965

Intervention Description

SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.

Intervention Type

Drug

Intervention Name(s)

Gemtuzumab ozogamicin

Other Intervention Name(s)

Mylotarg

Intervention Description

Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.

Primary Outcome Measure Information:

Title

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).

Title

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 Measure Information:

Title

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).

Title

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).

Title

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).

Title

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

23949430

Citation

Gojo I, Sadowska M, Walker A, Feldman EJ, Iyer SP, Baer MR, Sausville EA, Lapidus RG, Zhang D, Zhu Y, Jou YM, Poon J, Small K, Bannerji R. Clinical and laboratory studies of the novel cyclin-dependent kinase inhibitor dinaciclib (SCH 727965) in acute leukemias. Cancer Chemother Pharmacol. 2013 Oct;72(4):897-908. doi: 10.1007/s00280-013-2249-z. Epub 2013 Aug 15.

Results Reference

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

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