A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma

Trial ID or NCT#

NCT00744991

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase 2, Open-Label, Multicenter Study of Single-Agent Enzastaurin in Patients With Relapsed Cutaneous T-Cell Lymphoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

Youn H Kim, MD
Youn H Kim, MD
Dermatologic oncologist, Cutaneous oncology specialist, Dermatologist
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)
Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology
Richard Hoppe
Richard Hoppe
Radiation oncologist
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Contact us to find out if this trial is right for you.

Contact

Natalie Viakhireva
6507238949

View on ClinicalTrials.gov