Clinical trial · Interventional
Oral Enzastaurin in Participants With Relapsed Mantle Cell Lymphoma
A Phase 2 Study of Oral Enzastaurin HCl in Patients With Relapsed Mantle Cell Lymphoma
NCT00088205CI-TRIAL-00045757completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purposes of this study are to determine the safety of oral enzastaurin and any side effects that might be associated with it and whether enzastaurin can help participants with mantle cell lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle-Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzastaurin | Drug | Enzastaurin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: enzastaurin
Primary outcomes (1)
- measure
- Percentage of Participants With Freedom From Progression (FFP) for at Least 3 Cycles
- timeFrame
- Baseline through at least 3 cycles of treatment (28-day cycle)
- description
- Using the Standardized Response Criteria for non-Hodgkin's lymphomas, participants were considered to have progressive disease if there was a 50% increase in the sum of the products of the greatest diameters (SPD) of the dominant nodal and non-nodal sites or appearance of new-involved site or lesion. The percentage of FFP was computed as the number of participants documented to be progression free after 3 cycles of treatment divided by the number of treated participants and then multiplied by 100.
Secondary outcomes (11)
- measure
- Percentage of Participants With Complete Response (CR) Plus Unconfirmed Complete Response (CRu) Plus Partial Response (PR) (Objective Response Rate)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Mantle cell lymphoma * Previous treatment for mantle cell lymphoma * Previously relapsed mantle cell lymphoma with no more than 4 chemotherapy regimens. * Have discontinued all previous therapies for cancer, except corticosteroids up to 25 milligrams per day (mg/day) * Adequate organ function Exclusion Criteria: * Inability to swallow tablets * Must not have significant heart problems
References
Publications (1)
- BACKGROUNDDolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002. PMID 9366889