Clinical trial · Interventional
SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)
A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoblastic Leukemia, Acute | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
| SCH 727965 | Drug | Dinaciclib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Participants with AML randomized to SCH 727965
- interventionNames
- Drug: SCH 727965
- type
- ACTIVE_COMPARATOR
- label
- Participants with AML randomized to gemtuzumab ozogamicin
- interventionNames
- Drug: Gemtuzumab ozogamicin
- type
- EXPERIMENTAL
- label
- AML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin
- interventionNames
- Drug: SCH 727965
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTGojo 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. PMID 23949430