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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
In 2nd or subsequent relapse (RL) whether in CR or not after salvage therapy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have experienced a second or later relapse of your condition, regardless of whether you have fully recovered or not after receiving additional treatment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DLT
RP2D of Yttrium-90 labeled basiliximab
Secondary outcome measures
Best ORR
Biodistribution of basiliximab
Cumulative incidence of non-relapsed mortality (NRM)
+5 more

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
autologous hematopoietic stem cell transplantation
2003
Completed Phase 3
~1990
etoposide
1994
Completed Phase 3
~9300
carmustine
1994
Completed Phase 3
~2750
cytarabine
1997
Completed Phase 3
~10270
melphalan
1994
Completed Phase 3
~3530
basiliximab
2008
Completed Phase 4
~1170

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,426 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,250 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass elderly individuals aged 85 or above?

"This clinical study has a minimum age of eligibility set at 18 and the maximum age limit is 70 years old."

Answered by AI

Has this pharmaceutical research met the requirements of the FDA?

"The safety of this pharmacological study was rated a 1, as there is only minimal data available to evaluate its efficacy and potential risks."

Answered by AI

Are there any remaining vacancies for enrolment in this study?

"It appears that the post on clinicaltrials.gov reveals that this trial is no longer actively looking for participants. It was first published in November 2012 and last updated March 2022, leaving plenty of other trials (2305 to be precise) available for recruitment as we speak."

Answered by AI

Is there a possibility for me to join this experiment?

"Eligibility requirements for this study necessitate that participants have hodgkin's disease and are between 18-70 years old. Aproximately 25 patients need to be enrolled in the trial."

Answered by AI

What is the participant enrollment for this trial?

"Currently, this medical trial is not actively seeking participants. It was first posted on November 9th 2012 and its information was last updated on March 17th 2022. Should you be searching for other studies, there are 1,724 trials recruiting patients with Hodgkin Disease and 581 pharmaceutical studies currently enrolling subjects."

Answered by AI

What ailments have been successfully treated through pharmacological analysis?

"Hematopoietic stem cells are commonly managed with pharmacological study, and this method of treatment can also prove effective for merkel cell cancer, meningeal leukemia, and prostate cancer."

Answered by AI

Has there been any past research regarding the effects of pharmaceuticals?

"Currently, there are 581 pharmacological studies being conducted. 142 of them have progressed to Phase 3 and the majority take place in Ann Arbor, Michigan; however, 22318 medical institutions all over the globe are running trials for this medication."

Answered by AI
~2 spots leftby Mar 2025