Clinical trial · Interventional
A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma
A Phase 2, Open-Label, Multicenter Study of Single-Agent Enzastaurin in Patients With Relapsed Cutaneous T-Cell Lymphoma
NCT00744991CI-TRIAL-00047741completedPhase 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 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.
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 |
|---|---|---|---|
| Cutaneous T-Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzastaurin | Drug | Enzastaurin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Enzastaurin
- description
- Open Label
- interventionNames
- Drug: Enzastaurin
Primary outcomes (1)
- measure
- Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Among Mycosis Fungoides (MF) and Sezary Syndrome (SS) Participants (Response Rate)
- timeFrame
- Baseline to measured Progressive Disease (PD) [up to 9 cycles (28-day cycles)]
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDQuerfeld C, Kuzel TM, Kim YH, Porcu P, Duvic M, Musiek A, Rook AH, Mark LA, Pinter-Brown L, Hamid O, Lin B, Bian Y, Boye M, Day JM, Rosen ST. Multicenter phase II trial of enzastaurin in patients with relapsed or refractory advanced cutaneous T-cell lymphoma. Leuk Lymphoma. 2011 Aug;52(8):1474-80. doi: 10.3109/10428194.2011.572265. Epub 2011 Jun 8. PMID 21649541