Phase 2
N=57
A Study for Patients With Non-Hodgkin's Lymphomas
T-Cell Lymphoma · B-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00542919 ↗Enrolled (actual)
57
Serious AEs
43.9%
Results posted
Oct 2020
Primary outcome: Primary: Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) — 0; 0; 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- enzastaurin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Progression Free Survival (PFS) |
58; 227; 303; 429; 159; 114 | — |
| SECONDARY Time to Progressive (TTP) Disease |
58; 227; 308; 429; 159; 114 | — |
| SECONDARY Duration of Response (DOR) |
0; 394.0; 281.0; 1.0; 0; 58.0 | — |
| SECONDARY Percentage of Participants With Progression Free Survival (PFS) at 1-Year |
0.0; 36.8; 14.3; 51.4; 0.0; 25.0 | — |
| SECONDARY Number of Participants With One or More Drug-Related Adverse Events |
2; 3; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00542919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.