pharmacological study for Hodgkin Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hodgkin Disease+2 More
pharmacological study - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at the side effects and best dose of a cancer treatment that uses a radiolabeled monoclonal antibody, which attaches to cancer cells and delivers a cancer-killing substance, in conjunction with chemotherapy drugs. The trial is for patients whose Hodgkin lymphoma hasn't responded to treatment or has returned after treatment.

Eligible Conditions
  • Hodgkin Disease
  • Recurrent Adult Hodgkin's Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 5 years

For 30 days post-transplant
DLT
Year 5
Cumulative incidence of non-relapsed mortality (NRM)
Day 6
Biodistribution of basiliximab
Year 5
Overall survival (OS)
Year 5
Progression free survival (PFS)
Year 5
Response duration
Day 100
Incidence of toxicity
Up to 18 months
RP2D of Yttrium-90 labeled basiliximab
Up to 5 years
Best ORR
Cumulative incidence of relapse/progression incidence

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment (radiolabeled monoclonal antibody, chemotherapy)
1 of 1
Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: pharmacological study · No Placebo Group · Phase 1

Treatment (radiolabeled monoclonal antibody, chemotherapy)Experimental Group · 9 Interventions: laboratory biomarker analysis, carmustine, cytarabine, autologous hematopoietic stem cell transplantation, etoposide, pharmacological study, melphalan, basiliximab, yttrium Y 90-labeled basiliximab · Intervention Types: Other, Drug, Drug, Procedure, Drug, Other, Drug, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carmustine
FDA approved
Cytarabine
FDA approved
autologous hematopoietic stem cell transplantation
2004
Completed Phase 3
~1630
Etoposide
FDA approved
Melphalan
FDA approved
Basiliximab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,863 Total Patients Enrolled
198 Trials studying Hodgkin Disease
22,973 Patients Enrolled for Hodgkin Disease
City of Hope Medical CenterLead Sponsor
505 Previous Clinical Trials
2,249,002 Total Patients Enrolled
19 Trials studying Hodgkin Disease
1,191 Patients Enrolled for Hodgkin Disease
Eileen SmithPrincipal InvestigatorCity of Hope Medical Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.