Clinical trial · Interventional
A Study for Patients With Non-Hodgkin's Lymphomas
A Multicenter, Open-label, Noncomparative Study of Enzastaurin in Patients With Non-Hodgkin's Lymphomas
- 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)
In this study, all patients will get investigational drug. There will be no comparator drug. This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes: * T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL) * Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2) and marginal zone lymphoma * Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma.
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 |
|---|---|---|---|
| B-Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| T-Cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzastaurin | Drug | Enzastaurin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- T-Cell
- description
- T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 milligram (mg) loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days
- interventionNames
- Drug: enzastaurin
- type
- EXPERIMENTAL
- label
- Indolent B-Cell
- description
- Indolent B-Cell (IBCL): Small lymphocytic lymphoma, follicular lymphoma (Grade 1 or 2) and marginal zone lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have measurable lesions * Have recovered from prior chemotherapies * Have an estimated life expectancy of at least 12 weeks * Hepatic: total bilirubin less than or equal to 1.5 XULN; ATL/AST less than or equal to 2.0 x ULN (less than 5x if liver metastases are present) * Renal: serum creatinine less than or equal to 1.5XULN * Adequate bone marrow reserve: platelets greater than or equal to 75 x 109 /Liter (L) Criteria: * Have a second primary malignancy (except adequately treated nonmelanomatous skin cancer, or other cancer that is considered cured by surgical resection or radiation). * Anti-lymphoma therapy within the past 3 weeks * Unable to swallow tablets * Unable to discontinue use of carbamazepine, phenobarbital and phenytoin at least 14 days prior to study enrollment
References
Publications (1)
- DERIVEDForsyth CJ, Gomez-Almaguer D, Camargo JF, Eliadis PE, Crespo-Solis E, Pereira J, Gutierrez-Aguirre CH, Rivas-Vera S, Roberson S, Lin B, Smith NV, Hamid O. A multicenter, open-label, noncomparative screening study of enzastaurin in adult patients with non-Hodgkin lymphomas. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):398-403. doi: 10.1016/j.clml.2013.03.005. Epub 2013 Jun 14. PMID 23770158