Trial · NCT00744991
A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma
NCT00744991, 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 Participants With Relapsed Cutaneous T-Cell Lymphoma. Trials, record NCT00744991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00744991
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma
- NCT number
- NCT00744991
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Cutaneous T-Cell Lymphoma
- Interventions
- Enzastaurin
- First posted
- 2008-09-01
- Last updated
- 2020-10-19
- Results first posted
- 2020-10-19
- Limitations and caveats
- The study ended at Stage 1 as the minimum level of efficacy was not met.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate) | Baseline to measured Progressive Disease (PD) [up to 9 cycles (28-day cycles)] | Response rate is percentage of participants with confirmed CR or PR as per modified Severity-Weighted Assessment Tool (mSWAT) for MF group; mSWAT and Sezary count for SS group. mSWAT is a weighted sum of percent (%) of total body surface area attributed to skin lesions which yield a mSWAT score \[0 (unaffected) to 400 (severely affected)\] transformed into responses. As per mSWAT (CR: No detectable malignant disease for ≥4 weeks; PR: ≥50% mSWAT score reduction from baseline). Sezary cells percentage in lymphocytes measured using flow cytometry. As per Sezary count (CR: Sezary cells \<5%; PR: ≥50% reduction in Sezary cells from baseline). Response rate is calculated as total number of participants with CR or PR from the start of study treatment until PD or recurrence divided by the number of participants treated, then multiplied by 100. |
| Secondary | Duration of Response for Responding Participants | Time of response to PD [up to 9 cycles (28-day cycles)] | Time from first confirmed response \[Complete Response (CR) or Partial Response (PR)\] until Progressive Disease (PD) as per mSWAT for MF group; mSWAT and Sezary count for SS group. mSWAT: weighted sum of percent (%) of total body surface area attributed to skin lesions; scores \[0 (unaffected) to 400 (severely affected)\] transformed into responses. As per mSWAT (CR: No detectable malignant disease for ≥4 weeks; PR: ≥50% reduction in mSWAT score from baseline; PD: ≥25% of mSWAT score from nadir). Sezary cells percentage in lymphocytes measured using flow cytometry. As per Sezary count (CR: Sezary cells \<5%; PR: ≥50% reduction in Sezary cells from baseline; PD: ≥40% of Sezary cells from nadir). Responders or those who died without PD were censored at date of last progression-free disease assessment. Responders who received subsequent systemic anticancer therapy were censored at date of last progression-free disease assessment prior to post-discontinuation therapy. |
| Secondary | Time to Progression | Baseline to measured PD [up to 9 cycles (28-day cycles)] | Elapsed time from enrollment (baseline) to date of Progressive Disease (PD) as per mSWAT for Mycosis Fungoides (MF) group; mSWAT and Sezary count for Sezary Syndrome (SS) group. mSWAT: weighted sum of percent (%) of total body surface area attributed to skin lesions; scores \[0 (unaffected) to 400 (severely affected)\] transformed to responses. PD: ≥25% of mSWAT score from nadir. Sezary cells percentage in lymphocytes measured using flow cytometry. PD: ≥40% Sezary cells from nadir. Responders or those who died without PD were censored at the date of the last progression-free disease assessment. Responders who received subsequent systemic anticancer therapy were censored at the date of the last progression-free disease assessment prior to post-discontinuation therapy. |
| Secondary | Time to Objective Response for Responding Participants | Baseline to confirmed response [up to 9 cycles (28-day cycles)] | Elapsed time from date of study enrollment (baseline) to first evidence of Complete Response (CR) or Partial Response (PR) as per mSWAT for Mycosis Fungoides (MF) group; mSWAT and Sezary count for Sezary Syndrome (SS) group. mSWAT: weighted sum of percent (%) of total body surface area attributed to skin lesions; scores \[0 (unaffected) to 400 (severely affected)\] transformed into responses. As per mSWAT (CR: No detectable malignant disease for ≥4 weeks. PR: ≥50% mSWAT score reduction from baseline). Sezary cells percentage in lymphocytes measured using flow cytometry. As per Sezary count (CR: Sezary cells \<5%; PR: ≥50% reduction in Sezary cells from baseline). Response must be confirmed, but the time to objective response ended at the first assessment. Participants who were not confirmed responders did not contribute to the time to objective response calculation. |
| Secondary | European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Utility Score United States (US) Index (Participant-Reported Measure of Health-State Utility) | Baseline to study completion [up to 9 cycles (28-day cycles)], end of treatment reported | EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (1 (no problem), 2 (some problems), and 3 (extreme problems)). These combinations of attributes were converted into a single summary health-state index score by applying weights from the US-specific value set to the scoring algorithm. The EQ-5D US value set of health state index scores ranged from 0 (worst imagined health state) to 1 (best imagined health state). |
| Secondary | Pruritus 5-Item Severity Assessment Questionnaire (Participant-Reported Experiences With Pruritus) | Baseline to study completion [up to 9 cycles (28-day cycles)], end of treatment reported | Participants assessed their present level of itch through the use of an 11-point numeric rating scale anchored at 0 (no itch) and 10 (itch as bad as can be imagined). |
| Secondary | Change From Baseline in Itchy Quality of Life (QoL) Domain and Total Scores (Participant-Reported Experiences With Pruritus) | Baseline, up to study completion [up to 9 cycles (28-day cycles)], end of treatment reported | The Itchy QoL is a non-validated 22-item questionnaire designed to assess pruritus-associated symptoms with a 7-day recall using 3 domains: Emotions (9 items), Functions (7 items) and Symptoms domain (6 items). Each Itchy QoL item was evaluated by level of itch frequency through the use of a 5-point adjectival scale 1 (never), 2 (rarely), 3 (sometimes), 4 (often), 5 (all the time). Unweighted means were calculated individually for the 3 domains each with scores range from 1 to 5 and the total score is expressed as the mean of the three dimension scores and ranges from 1 (no itch) to 5 (worst imaginable itch). |
| Secondary | Number of Participants With Adverse Events (AEs) or Deaths (Safety and Tolerability of Enzastaurin) | Baseline to study completion [up to 9 cycles (28-day cycles)] plus 30-day safety follow-up | Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality, deaths during the study including 30 days after treatment discontinuation. A summary of SAEs and other non-SAEs regardless of causality is located in the Reported Adverse Events module. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate) | Baseline to measured Progressive Disease (PD) [up to 9 cycles (28-day cycles)] | All participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response for Responding Participants | Time of response to PD [up to 9 cycles (28-day cycles)] | Participants with confirmed response (CR or PR). Only 1 participant in MF group had confirmed PR. | days | MEDIAN |
| SECONDARY | Time to Progression | Baseline to measured PD [up to 9 cycles (28-day cycles)] | All participants who received at least 1 dose of study drug. Ten (10) participants were censored for MF group and 2 participants were censored for SS group for this analysis. | days | MEDIAN |
| SECONDARY | Time to Objective Response for Responding Participants | Baseline to confirmed response [up to 9 cycles (28-day cycles)] | Participants with confirmed response (CR or PR). Only 1 participant in MF group had confirmed PR. | days | MEDIAN |
| SECONDARY | European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Utility Score United States (US) Index (Participant-Reported Measure of Health-State Utility) | Baseline to study completion [up to 9 cycles (28-day cycles)], end of treatment reported | Enrolled participants who had a baseline and at least 1 post-baseline EQ-5D observation. Last available assessment was reported, last available assessment for a given endpoint defined as efficacy summaries presented as end of study summary. | units on a scale | MEAN |
| SECONDARY | Pruritus 5-Item Severity Assessment Questionnaire (Participant-Reported Experiences With Pruritus) | Baseline to study completion [up to 9 cycles (28-day cycles)], end of treatment reported | Enrolled participants who had a baseline and at least 1 post-baseline pruritus assessment observation. Last available assessment was reported, last available assessment for a given endpoint defined as efficacy summaries presented as end of study summary. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Itchy Quality of Life (QoL) Domain and Total Scores (Participant-Reported Experiences With Pruritus) | Baseline, up to study completion [up to 9 cycles (28-day cycles)], end of treatment reported | Enrolled participants who had a baseline and at least 1 post-baseline Itchy QoL observation. Last available assessment was reported, last available assessment for a given endpoint defined as efficacy summaries presented as end of study summary. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) or Deaths (Safety and Tolerability of Enzastaurin) | Baseline to study completion [up to 9 cycles (28-day cycles)] plus 30-day safety follow-up | Participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate) | Mycosis Fungoides (MF) | Partial Response (PR) | 5.3 | 95% Confidence Interval 0.1 to 26.0 | percentage of participants |
| Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate) | Sezary Syndrome (SS) | Partial Response (PR) | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate) | Mycosis Fungoides (MF) | Complete Response (CR) | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate) | Sezary Syndrome (SS) | Complete Response (CR) | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Duration of Response for Responding Participants | Mycosis Fungoides (MF) | 141 | 95% Confidence Interval NA to NA | days | |
| Time to Progression | Mycosis Fungoides (MF) | 78 | 95% Confidence Interval 50 to 107 | days | |
| Time to Progression | Sezary Syndrome (SS) | 44 | 95% Confidence Interval 4 to 82 | days | |
| Time to Objective Response for Responding Participants | Mycosis Fungoides (MF) | 50 | 95% Confidence Interval NA to NA | days | |
| European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Utility Score United States (US) Index (Participant-Reported Measure of Health-State Utility) | Enzastaurin | 0.7 | Standard Deviation 0.2 | units on a scale | |
| Pruritus 5-Item Severity Assessment Questionnaire (Participant-Reported Experiences With Pruritus) | Enzastaurin | 5.0 | Standard Deviation 3.6 | units on a scale |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enzastaurin | 25 | |
| Overall Study | Received at Least 1 Dose | Enzastaurin | 25 | |
| Overall Study | COMPLETED | Enzastaurin | 0 | |
| Overall Study | NOT COMPLETED | Enzastaurin | 25 |
Source ClinicalTrials.gov
Adverse events32
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 | Constipation | Gastrointestinal disorders | Enzastaurin | 2 | 25 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Enzastaurin | 6 | 25 | 7 |
| other | Nausea | Gastrointestinal disorders | Enzastaurin | 3 | 25 | 4 |
| other | Chills | General disorders | Enzastaurin | 2 | 25 | 2 |
| other | Fatigue | General disorders | Enzastaurin | 6 | 25 | 6 |
| other | Oedema peripheral | General disorders | Enzastaurin | 5 | 25 | 5 |
| other | Staphylococcal infection | Infections and infestations | Enzastaurin | 2 | 25 | 2 |
| other | Urinary tract infection | Infections and infestations | Enzastaurin | 2 | 25 | 2 |
| other | Decreased appetite | Metabolism and nutrition disorders | Enzastaurin | 2 | 25 | 2 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Enzastaurin | 2 | 25 | 2 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enzastaurin | ||
| Total, other adverse events | Enzastaurin | 19 | 25 |
| Total, serious adverse events | Enzastaurin | 5 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21649541 | 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.
GET https://conductscience.org/api/trials/v1/NCT00744991
GET https://conductscience.org/api/trials/v1/NCT00744991/events?page=2