Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00798213
Other study ID # P04717
Secondary ID
Status Terminated
Phase Phase 2
First received November 25, 2008
Last updated February 3, 2015
Start date January 2009
Est. completion date April 2010

Study information

Verified date February 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 29
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
Gemtuzumab ozogamicin
Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 leuk — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL. Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months). No
Primary Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator. Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months). No
Secondary Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL. Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months). No
Secondary Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML. Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months). No
Secondary Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML. Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months). No
Secondary Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months). No
See also
  Status Clinical Trial Phase
Recruiting NCT05319587 - Study of Liposomal Annamycin in Combination With Cytarabine for the Treatment of Subjects With Acute Myeloid Leukemia (AML) Phase 1/Phase 2
Active, not recruiting NCT04090736 - Study to Compare Azacitidine Plus Pevonedistat Versus Azacitidine in Patients With Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy Phase 3
Completed NCT01617226 - Randomised Study of Azacitidine Versus Azacitidine With Vorinostat in Patients With AML or High Risk MDS Phase 2
Terminated NCT00916045 - Pilot Study of Unrelated Cord Blood Transplantation Phase 2
Terminated NCT00957580 - Trial of Pimasertib in Hematological Malignancies Phase 2
Completed NCT00640796 - Pilot Study of Expanded, Donor Natural Killer Cell Infusions for Refractory Non-B Lineage Hematologic Malignancies and Solid Tumors Phase 1
Completed NCT00458250 - Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H Phase 1
Active, not recruiting NCT05424380 - A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS Phase 1
Completed NCT01690624 - BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients in Complete Remission With High Risk to Relapse Phase 1
Recruiting NCT05471700 - Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients Phase 1/Phase 2
Not yet recruiting NCT05016063 - Dual CD33-CLL1-CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia Early Phase 1
Not yet recruiting NCT04450784 - ObServatory Children Acute RElated Therapy Leukemia
Recruiting NCT04265963 - CD123-Targeted CAR-T Cell Therapy for Relapsed/Refractory Acute Myeloid Leukemia Phase 1/Phase 2
Terminated NCT04968860 - Oral Health Condition and Quality of Life in Children With Leukemia
Recruiting NCT03793517 - Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT Phase 2/Phase 3
Terminated NCT02841540 - A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes Phase 1
Recruiting NCT05453903 - A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies Phase 1
Completed NCT03720366 - A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients Phase 1
Withdrawn NCT04230564 - Acute Myeloid Leukemia Real World Treatment Patterns
Terminated NCT03761069 - Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias Phase 1