Phase 2
N=25
A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma
Cutaneous T-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00744991 ↗Enrolled (actual)
25
Serious AEs
20.0%
Results posted
Oct 2020
Primary outcome: Primary: Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate) — 5.3; 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
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate) |
5.3; 0; 0; 0 | — |
| SECONDARY Duration of Response for Responding Participants |
141 | — |
| SECONDARY Time to Progression |
78; 44 | — |
| SECONDARY Time to Objective Response for Responding Participants |
50 | — |
| 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) |
0.7 | — |
| SECONDARY Pruritus 5-Item Severity Assessment Questionnaire (Participant-Reported Experiences With Pruritus) |
5.0 | — |
| SECONDARY Change From Baseline in Itchy Quality of Life (QoL) Domain and Total Scores (Participant-Reported Experiences With Pruritus) |
-0.02; -0.09; 0.23; 0.03 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) or Deaths (Safety and Tolerability of Enzastaurin) |
20; 5; 1 | — |
Summary
The purpose of the study is to determine the efficacy and safety of enzastaurin in participants with Cutaneous T-Cell Lymphoma (CTCL) who failed prior therapies.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed mycosis fungoides or Sezary Syndrome.
- Stage IB to IVB disease at screening.
- Recurrent or refractory disease after at least 1 prior systemic therapy.
- Have adequate organ function defined as:
- Hepatic: total bilirubin ≤1.5 times the upper limit of normal (ULN); alanine transaminase/aspartate transaminase (ALT/AST) ≤2.5 times the ULN.
- Renal: serum creatinine ≤1.5 times the ULN.
- Adequate bone marrow reserve: platelets ≥75 * 10^9/Liters (L); absolute neutrophil count (ANC) ≥1.0 * 10^9/L.
- At least 30 days must have passed since other treatment for CTCL.
Exclusion Criteria
- Receiving concurrent treatment for CTCL.
- Unable to swallow tablets.
- Receiving high potency oral or topical steroids. Low potency oral steroid may be permitted in participants who have been on a stable dose for at least 4 weeks prior to screening. Oral or topical antihistamine is allowed.
- Unable to discontinue use of carbamazepine, phenobarbital, or phenytoin.
- Have a serious concomitant systemic disorder or Human Immunodeficiency Virus (HIV).
- Have a serious cardiac condition such as myocardial infarction within past 6 months, angina, or heart disease as defined by the New York Heart Association (NYHA) Class III or IV.
- Have electrocardiogram (ECG) abnormalities.
- Are pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT00744991). 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.