Conditions

Outcome Measures

Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate)
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.
Baseline to measured Progressive Disease (PD) [up to 9 cycles (28-day cycles)]

Duration of Response for Responding Participants
Time of response to PD [up to 9 cycles (28-day cycles)]
Time to Progression
Baseline to measured PD [up to 9 cycles (28-day cycles)]
Time to Objective Response for Responding Participants
Baseline to confirmed response [up to 9 cycles (28-day cycles)]
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
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
+2 more secondary outcomes

EXPERIMENTAL

Open Label

Drug: Enzastaurin

1125 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression

Also known as: LY317615

Enzastaurin

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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.

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.

Contact the study team to confirm eligibility.