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Alkylating agents

Radiolabeled Monoclonal Antibody + Chemotherapy Before Stem Cell Transplant for Hodgkin Lymphoma

Phase 1
Waitlist Available
Led By Eileen Smith
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for adults with Hodgkin lymphoma that didn't respond to initial treatment or came back after therapy. Participants must have acceptable organ function, not be pregnant or breastfeeding, agree to use birth control, and have collected enough stem cells for transplant. They should not have had certain previous treatments like high-dose chemo with stem cell transplant or radiation to critical organs.
What is being tested?
The study tests a radiolabeled monoclonal antibody (yttrium Y 90-labeled basiliximab) combined with BEAM chemotherapy before a stem cell transplant in patients whose Hodgkin lymphoma has relapsed or was resistant from the start. The goal is to see how well this approach works and what the best dose of the antibody therapy might be.
What are the potential side effects?
Potential side effects include reactions related to the monoclonal antibody such as allergic responses, damage to normal cells by radiation, typical chemotherapy side effects like nausea, fatigue, hair loss, increased risk of infections due to low blood counts and potential harm to fertility.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
DLT
RP2D of Yttrium-90 labeled basiliximab
Secondary study objectives
Best ORR
Biodistribution of basiliximab
Cumulative incidence of non-relapsed mortality (NRM)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (radiolabeled monoclonal antibody, chemotherapy)Experimental Treatment9 Interventions
DOSIMETRY STUDY: Patients receive basiliximab IV and indium In 111 basiliximab IV on day -21. Patients undergo indium In 111 imaging scans daily. Patients with appropriate biodistribution continue on to treatment. TREATMENT: Patients receive basiliximab IV and yttrium Y 90 basiliximab IV on day -14. Patients also receive BEAM chemotherapy comprising carmustine IV over 2 hours on days -7 and -6, etoposide IV BID over 4 hours and cytarabine IV over 2 hours BID on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic progenitor cell infusion on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
carmustine
1994
Completed Phase 3
~2750
etoposide
1994
Completed Phase 3
~9300
cytarabine
1997
Completed Phase 3
~10270
melphalan
1994
Completed Phase 3
~3530
autologous hematopoietic stem cell transplantation
2003
Completed Phase 3
~1990
basiliximab
2008
Completed Phase 4
~1170

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,422 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,145 Total Patients Enrolled
Eileen SmithPrincipal InvestigatorCity of Hope Medical Center

Media Library

Carmustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01476839 — Phase 1
Adult Hodgkin's Lymphoma Research Study Groups: Treatment (radiolabeled monoclonal antibody, chemotherapy)
Adult Hodgkin's Lymphoma Clinical Trial 2023: Carmustine Highlights & Side Effects. Trial Name: NCT01476839 — Phase 1
Carmustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01476839 — Phase 1
~2 spots leftby Dec 2025