Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00051012
NCT00051012
Completed
Phase 4

A Multicenter Open-Label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-Cell Lymphoma (CTCL) Patients Following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or Who Meet the Requirements for Protocol 93-04-11 Except Have Biopsy-Documented CTCL That Does Not Express CD25

Eisai Inc.34 sites in 9 countries86 target enrollmentSeptember 1995
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsLymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome
DrugsONTAK

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Lymphoma, T-Cell, Cutaneous
Sponsor
Eisai Inc.
Enrollment
86
Locations
34
Primary Endpoint
Objective Rate of Response (ORR), defined as CR + CCR + PR
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.

Registry
clinicaltrials.gov
Start Date
September 1995
End Date
December 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Eisai Inc.

Eligibility Criteria

Inclusion Criteria

  • •Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.
  • •CTCL disease Stage Ia - III.
  • •History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.
  • •Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN
  • •No CTCL involvement of bone marrow.
  • •No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease.
  • •No systemic infections.
  • •ECOG performance status of 0 or 1.

Exclusion Criteria

  • •The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.

Outcomes

Primary Outcomes

Objective Rate of Response (ORR), defined as CR + CCR + PR

Secondary Outcomes

  • Time-to-Treatment Failure
  • Time-to-Progression
  • Duration of Response

Study Sites (34)

Loading locations...

Similar Trials

Completed
Phase 3
Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseModerate and Severe Active Rheumatoid ArthritisActive Psoriatic ArthritisActive Ankylosing SpondylitisModerately to Severely Active Crohn's Disease
NCT03357471UCB Biopharma S.P.R.L.70
Completed
Phase 3
An Evaluation of Etanercept in the Treatment of Subjects With PsoriasisPsoriasis
NCT00111111Amgen
Completed
Phase 4
Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor TreatmentAlzheimer's Disease
NCT00234637Novartis204
Terminated
Phase 2
A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's DiseaseHuntington's Disease
NCT02494778Prilenia248
Completed
Phase 3
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)Multiple Sclerosis, Relapsing-Remitting
NCT02861014Hoffmann-La Roche681