Clinical trial · Interventional
SCH 727965 in Patients With Mantle Cell Lymphoma or B-Cell Chronic Lymphocytic Leukemia (Study P04715)
A Randomized Phase 2 Study of SCH 727965 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL) or B-Cell Chronic Lymphocytic Leukemia (B-CLL)
- 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 will be randomized to SCH 727965 or a comparator drug (bortezomib for mantle cell lymphoma \[MCL\] or alemtuzumab for B cell chronic lymphocytic leukemia \[B CLL\]). Part 1 of the study will determine the activity of SCH 727965 treatment in participants with MCL and participants with B-CLL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants who experienced disease progression after standard treatment with the comparator drug 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, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Biological | Alemtuzumab | ALIAS |
| Bortezomib | Drug | Bortezomib | ALIAS |
| SCH 727965 | Drug | Dinaciclib | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Participants with MCL randomized to SCH 727965
- interventionNames
- Drug: SCH 727965
- type
- ACTIVE_COMPARATOR
- label
- Participants with MCL randomized to bortezomib
- interventionNames
- Drug: Bortezomib
- type
- EXPERIMENTAL
- label
- MCL treated w/SCH 727965 after progression on bortezomib
- interventionNames
- Drug: SCH 727965
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>=18 years, either sex, any race. * Eastern Cooperative Oncology group performance status of 0 or 1. * Adequate hematologic, renal, and hepatic organ function and laboratory parameters. * For subjects with MCL: * Diagnosis of MCL according to the World Health Organization (WHO) criteria. * Received at least one prior chemotherapeutic regimen, but no more than two regimens including stem cell transplantation.. * Measurable or assessable disease by the Revised Response Criteria for Malignant Lymphoma. * For subjects with B-CLL * Documented B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria. * Received at least one prior alkylating agent-based regimen and one fludarabine- or pentostatin-containing regimen, but must not have received more than two prior regimens. * Measurable or assessable disease by NCI-WG criteria. Exclusion Criteria: * Known central nervous system involvement of MCL or B-CLL. * Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors. * For MCL, previous treatment with bortezomib. * For B-CLL, previous treatment with alemtuzumab. * Known HIV infection. * Known active hepatitis B or C.
References
Publications (0)
Data not yet available