Trial · NCT00542919
A Study for Patients With Non-Hodgkin's Lymphomas
NCT00542919, Phase 2, Completed, Eli Lilly and Company; results first posted 2020-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study for Patients With Non-Hodgkin's Lymphomas. Trials, record NCT00542919. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00542919
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Patients With Non-Hodgkin's Lymphomas
- NCT number
- NCT00542919
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- T-Cell Lymphoma, B-Cell Lymphoma
- Interventions
- enzastaurin
- First posted
- 2007-10-12
- Last updated
- 2020-10-19
- Results first posted
- 2020-10-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Baseline to Measured Progressive Disease (Up to 114 Months) | Tumor RR is defined as the number of responders divided by the number of treated participants for that tumor subtype. A responder was a participant who exhibited: a CR defined as a modified severity-weighted assessment tool (mSWAT) value of zero or a partial response (PR) defined as a mSWAT value \> 50% decrease from baseline \[for participants with cutaneous T-cell lymphoma (CTCL) using the mSWAT or CR, unconfirmed CR (Cru), or PR as defined by Abrey et al., (2005) (for participants with central nervous system (CNS) Lymphoma); or for all other participants a CR or complete response - unconfirmed (CRu) or PR as defined by Cheson et al., (1999). |
| Secondary | Progression Free Survival (PFS) | Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months) | Progression-free survival is defined as the time from the date of study enrollment to the first date of objectively determined progressive disease or death from any cause. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment. |
| Secondary | Time to Progressive (TTP) Disease | Baseline to Measured Progressive Disease (Up to 114 Months) | TTP disease is defined as the time from the date of study enrollment to the date of objectively determined disease progression. Objectively determined progressive disease (PD) was interpreted as meeting the criteria for PD. For patients who died without documented objective PD (including death from study disease); TTP was censored at the date of the last objective progression-free disease assessment prior to death. For participants not known to have died as of the data cut-off date and who did not have objective PD, TTP was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, TTP was censored at the date of the last objective progression free disease assessment prior to post-discontinuation therapy. |
| Secondary | Duration of Response (DOR) | Baseline to Measured Progressive Disease (Up to 97 Months) | DoR is defined as the time from the date when the measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the date of first observation of objectively determined disease progression (CR, CRu, or PR see above definition of responder). For responding participants who died without PD (including death from study disease), DoR was censored at the last assessment demonstrating lack of progression. For responding patients not known to have died as of the data cut-off date and who did not have PD, DoR was censored at the last assessment demonstrating objective response prior to the data cut-off date. For responding participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression, DoR was censored at the last assessment demonstrating objective response prior to the initiation of post-discontinuation anticancer therapy. |
| Secondary | Percentage of Participants With Progression Free Survival (PFS) at 1-Year | Baseline to Measured Progressive Disease or Death From Any Cause (1 Year) | PFS at 1 year was defined as the probability of being alive and having not progressed at 1 year and calculated from the PFS Kaplan-Meier analysis. PFS was censored at the date of the last objective progression-free assessment. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment. |
| Secondary | Number of Participants With One or More Drug-Related Adverse Events | Baseline to End of Study (Up to 114 Months) | Number of participants with one or more Drug-Related Adverse Events. Clinically significant events are defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Baseline to Measured Progressive Disease (Up to 114 Months) | All participants with all tumor subtypes, who received at least one dose of study drug, and had evaluable tumor response rate data. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months) | All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable PFS data. Participants censored: 0 (PTCL), 3 (CTCL), 0 (small lymphocytic), 2 (follicular grade 1 \& 2), 0 (follicular grade 3a and 4b), 0 (marginal zone) and 4 (history of IBCL) | Days | MEDIAN |
| SECONDARY | Time to Progressive (TTP) Disease | Baseline to Measured Progressive Disease (Up to 114 Months) | All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable TTP data. Participants censored: 0 (PTCL), 3 (CTCL), 0 (small lymphocytic), 2 (follicular grade 1 \& 2), 0 (follicular grade 3a and 4b), 0 (marginal zone) and 4 (history of IBCL) | Days | MEDIAN |
| SECONDARY | Duration of Response (DOR) | Baseline to Measured Progressive Disease (Up to 97 Months) | All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable DOR data. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Progression Free Survival (PFS) at 1-Year | Baseline to Measured Progressive Disease or Death From Any Cause (1 Year) | All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable 1-year rate PFS data. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With One or More Drug-Related Adverse Events | Baseline to End of Study (Up to 114 Months) | All participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Peripheral T-cell Lymphoma (PTCL) | CR | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Cutaneous T-cell Lymphoma (CTCL) | CR | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | CR | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Follicular Grade 1 & 2 (IBCL) | CR | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Marginal Zone Lymphoma (IBCL) | CR | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | CR | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | History of IBCL (ABCL) | CR | 10.0 | 95% Confidence Interval 0.3 to 44.5 | percentage of participants |
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Peripheral T-cell Lymphoma (PTCL) | CRu | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Cutaneous T-cell Lymphoma (CTCL) | CRu | 9.1 | 95% Confidence Interval 0.2 to 41.3 | percentage of participants |
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | CRu | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | T-Cell (TCL) | 23 | |
| Overall Study | STARTED | Indolent B-Cell (IBCL) | 19 | |
| Overall Study | STARTED | Aggressive B-Cell (ABCL) | 15 | |
| Overall Study | Received At Least One Dose of Study Drug | T-Cell (TCL) | 23 | |
| Overall Study | Received At Least One Dose of Study Drug | Indolent B-Cell (IBCL) | 19 | |
| Overall Study | Received At Least One Dose of Study Drug | Aggressive B-Cell (ABCL) | 15 | |
| Overall Study | Progressive Disease | T-Cell (TCL) | 15 | |
| Overall Study | Progressive Disease | Indolent B-Cell (IBCL) | 11 | |
| Overall Study | Progressive Disease | Aggressive B-Cell (ABCL) | 7 | |
| Overall Study | Death | T-Cell (TCL) | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events633
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | T-Cell | 5 | 23 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Indolent B-Cell | 3 | 19 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Aggressive B-Cell | 3 | 15 | 3 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | T-Cell | 1 | 23 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Indolent B-Cell | 0 | 19 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Aggressive B-Cell | 0 | 15 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | T-Cell | 1 | 23 | 2 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Indolent B-Cell | 2 | 19 | 3 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Aggressive B-Cell | 1 | 15 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | T-Cell | 0 | 23 | 0 |
1 to 10 of 633Source ClinicalTrials.gov
See all 633 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T-Cell | ||
| Total, all-cause mortality | Indolent B-Cell | ||
| Total, all-cause mortality | Aggressive B-Cell | ||
| Total, other adverse events | T-Cell | 19 | 23 |
| Total, other adverse events | Indolent B-Cell | 17 | 19 |
| Total, other adverse events | Aggressive B-Cell | 10 | 15 |
| Total, serious adverse events | T-Cell | 9 | 23 |
| Total, serious adverse events | Indolent B-Cell | 11 | 19 |
| Total, serious adverse events | Aggressive B-Cell | 5 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23770158 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT00542919/results?page=2