Your session is about to expire
← Back to Search
Immunotoxin
Denileukine Diftitox for Relapsed ALCL
Phase 2
Waitlist Available
Led By Mitchell S Cairo, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
The purpose of this study is to determine is Denileukin diftitox will be safe, well tolerated and induce a significant overall response alone and in combination with chemotherapy: ifosfamide, carboplatin and etoposide (ICE) and will be safe and well tolerated in a population of children, adolescents and young adults with relapsed or refractory anaplastic large cell lymphoma (ALCL).
Eligible Conditions
- Anaplastic Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: DD with ICE ChemotherapyExperimental Treatment1 Intervention
For patients who show a response to DD alone after 4 cycles or for patients who show progressive disease after 2 cycles, DD will be given with ICE chemotherapy for 2 cycles.
Group II: DD AloneExperimental Treatment1 Intervention
Patients will get Denileukin Diftitox for 5 days every 3 weeks for a total of 4 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denileukin diftitox
FDA approved
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,498 Previous Clinical Trials
2,768,981 Total Patients Enrolled
Mitchell S Cairo, MDPrincipal InvestigatorColumbia University
14 Previous Clinical Trials
1,168 Total Patients Enrolled