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Alkylating agents

Radioimmunotherapy + BEAM Chemotherapy for Hodgkin's Lymphoma

Phase 2
Recruiting
Led By Alex F Herrera
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
High risk relapsed or refractory HL disease defined as having any one of the following: B symptoms at relapse, Extranodal disease at relapse, Primary refractory disease, Relapse < 1 year after completion of frontline therapy, Not in CR at the time of transplant, Relapse after receiving PD1 blockade or brentuximab vedotin as initial therapy, Patients will be enrolled after collection of at least 2.0 x 10^6 CD34 cells/kg of autologous hematopoietic progenitor cells (HPC-A) by apheresis, Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v]5), Serum creatinine =< 1.5 mg/dL (performed prior to day 1 of protocol therapy), Creatinine clearance of >= 60 mL/min per 24 hour urine test =< 1.5 mg/dL (performed prior to day 1 of protocol therapy), Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (performed prior to day 1 of protocol therapy), Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) =< 1.5 x ULN (except in cases where abnormal liver function tests (LFTs) are due to involvement with HL) (performed prior to day 1 of protocol therapy), Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 1.5 x ULN (except in cases where abnormal LFTs are due to involvement with HL) (performed prior to day 1 of protocol therapy), Left ventricular ejection fraction (LVEF) >= 50% (performed prior to day 1 of protocol therapy), Forced expiratory volume in 1 second (FEV1) > 65% of predicted measured, or DLCO (diffusion capacity) >= 50% of predicted measured (corrected for hemoglobin) (performed prior to day 1 of protocol therapy), Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least six months after the last dose of protocol therapy, Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
1st relapsed HL in a patient who is not in CR after 2 different salvage therapy regimens to attain CR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment up to 5 years post transplant
Awards & highlights

Study Summary

This trial is studying how well yttrium-90-labeled anti-CD25 monoclonal antibody combined with BEAM chemotherapy works in treating patients with Hodgkin lymphoma.

Who is the study for?
Adults over 18 with Hodgkin lymphoma that hasn't improved or has returned after treatment can join this trial. They must have a life expectancy of at least 6 months, be in good physical condition, and have collected enough stem cells for transplant. People who've had certain previous treatments, significant organ damage from radiation, active hepatitis B or C, HIV with low CD4 counts, pregnancy, or other serious health issues cannot participate.Check my eligibility
What is being tested?
The trial is testing a radioactive antibody called Yttrium-90 Basiliximab combined with BEAM chemotherapy (carmustine, etoposide, cytarabine) before stem cell transplant in patients with stubborn or returning Hodgkin lymphoma. The goal is to see if this combo can better kill cancer cells and make space for new blood-forming cells to grow.See study design
What are the potential side effects?
Possible side effects include reactions to the monoclonal antibody like fever and chills; effects from radioactivity such as nausea; and typical chemotherapy side effects like fatigue, hair loss, mouth sores and increased risk of infections due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Hodgkin's lymphoma has returned after two treatments and I'm not in complete remission.
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I am able to care for myself but may not be able to do active work.
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I am 18 years old or older.
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I am in or beyond my second round of treatment for relapsed lymphoma.
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My condition is confirmed as Hodgkin lymphoma.
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My condition has returned or didn't respond to treatment.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival
Secondary outcome measures
Incidence of infection
Incidence of toxicities and adverse events
Non-relapse mortality
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)Experimental Treatment7 Interventions
Patients receive 'cold' basiliximab IV followed by yttrium Y 90 basiliximab IV on day -14. Patients also receive carmustine IV on over 4 hours day -6, etoposide IV over 1 hours QD and cytarabine IV over 2 hours BID or QD on days -5 to -2, and melphalan IV over 1 hours on day -1. Patients then receive HPC-A product via infusion on day 0. Beginning day 5, patients receive G-CSF (or biosimilar) SC or IV until ANC > 500 for 3 consecutive days or according to the treating physician's best clinical judgement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Basiliximab
2006
Completed Phase 4
~4130
Carmustine
1990
Completed Phase 3
~1790
Cytarabine
2016
Completed Phase 3
~3310
Etoposide
2010
Completed Phase 3
~2440
Recombinant Granulocyte Colony-Stimulating Factor
2018
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,427 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,872 Total Patients Enrolled
Alex F HerreraPrincipal InvestigatorCity of Hope Medical Center
11 Previous Clinical Trials
1,528 Total Patients Enrolled

Media Library

Carmustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04871607 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)
Hodgkin's Lymphoma Clinical Trial 2023: Carmustine Highlights & Side Effects. Trial Name: NCT04871607 — Phase 2
Carmustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04871607 — Phase 2

Frequently Asked Questions

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

How many people are included as subjects in this clinical trial?

"That is correct, the online information from clinicaltrials.gov does show that this study is looking for 33 patients at 1 site. The posting date was November 2nd, 2021 and it has been updated as recently as June 16th, 2022."

Answered by AI

Has the FDA given Yttrium - 90 Basiliximab the okay for therapeutic use?

"While there is some data suggesting that Yttrium - 90 Basiliximab is safe, as it is only a Phase 2 trial, there is no evidence yet of its efficacy."

Answered by AI

Are participants still being enrolled in this research program?

"That is accurate. The most recent update on clinicaltrials.gov suggests that this trial, which was established on November 2nd 2021, is looking for 33 individuals from 1 site."

Answered by AI

How is Yttrium - 90 Basiliximab typically employed?

"Yttrium - 90 Basiliximab is a common treatment for merkel cell cancer, but can also be used to target other forms of cancer like meningeal leukemia, prostate cancer, and small cell lung cancer."

Answered by AI

Is there prior research on Yttrium - 90 Basiliximab?

"522 different clinical trials are currently underway to test the efficacy of Yttrium - 90 Basiliximab. 137 of those trials have progressed to Phase 3 testing. Most of the research being conducted is based in Seattle, Washington; however, there are 21365 locations running similar studies."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma
2021. "Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04871607.
~19 spots leftby Oct 2027
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