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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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