What is the mechanism of action of this treatment?

The most common treatments for Cutaneous T-Cell Non-Hodgkin Lymphoma (CTCL) include radioimmunotherapy, such as Yttrium Y 90 Basiliximab, which combines radioactive isotopes with monoclonal antibodies to specifically target and destroy cancer cells. This approach leverages the precision of monoclonal antibodies to deliver radiation directly to the tumor, minimizing damage to surrounding healthy tissue. This is particularly important for CTCL patients as it offers a targeted treatment option that can effectively reduce tumor burden while potentially limiting side effects compared to traditional chemotherapy. Other treatments may include systemic therapies like chemotherapy, which works by killing rapidly dividing cells, and targeted therapies that inhibit specific pathways essential for cancer cell survival.

What side effects are associated with this type of intervention?

Treatments for Cutaneous T-Cell Non-Hodgkin Lymphoma, particularly radioimmunotherapy like Yttrium Y 90 Basiliximab, commonly cause side effects such as fatigue, nausea, and cytopenias (low blood cell counts) due to radiation toxicity. When combined with chemotherapy agents like carmustine, cytarabine, etoposide, and melphalan, additional side effects include myelosuppression, increased infection risk, gastrointestinal issues, and potential organ toxicity. Close monitoring is essential to manage these adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Cutaneous T-Cell Non-Hodgkin Lymphoma, including radioimmunotherapy approaches. One notable example is the use of brentuximab vedotin, an antibody-drug conjugate targeting CD30, which has shown efficacy in treating this type of lymphoma. Additionally, other treatments like bexarotene and vorinostat, which are not radioimmunotherapies but target cancer cells through different mechanisms, have also been approved. While Yttrium Y 90 Basiliximab represents a novel approach by combining radiation with monoclonal antibodies to target cancer cells, similar radioimmunotherapy treatments have been explored in other types of lymphomas, such as ibritumomab tiuxetan (Zevalin) for B-cell non-Hodgkin lymphoma.

What other types of research exist?

Promising novel alternatives for CTCL patients in 2024 include: 1) Brentuximab vedotin, an antibody-drug conjugate targeting CD30-positive lymphoma cells. 2) Mogamulizumab, a monoclonal antibody targeting CCR4, effective in relapsed or refractory CTCL. 3) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, showing efficacy in various lymphomas. 4) CAR T-cell therapy, which involves engineering a patient's T-cells to target cancer cells, showing promise in hematologic malignancies. These therapies offer targeted approaches with potential for improved outcomes.

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Monoclonal Antibodies

Radioimmunotherapy + Chemotherapy Before Stem Cell Transplant for T-Cell Lymphoma

Phase 1

Waitlist Available

Led By Jasmine Zain, MD

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 from start of therapy (stem cell infusion) to death from any cause, assessed up to 2 years post-transplant

Awards & highlights

Summary

This trial uses a radioactive drug and chemotherapy to treat patients with T-cell non-Hodgkin lymphoma. The treatment aims to kill cancer cells and prepare the body for a stem cell transplant. Radioimmunotherapy has shown good results in earlier studies for non-Hodgkin's lymphoma, even in patients that do not respond to standard chemotherapy.

Who is the study for?

This trial is for patients with mature T-cell non-Hodgkin lymphoma who can undergo high-dose therapy and stem cell transplant. They must have a Karnofsky status of at least 70%, agree to use contraception, have adequate organ function, and collected enough stem cells for the procedure. Excluded are those with prior transplants, uncontrolled illnesses, certain allergies or previous treatments that might interfere.

What is being tested?

The trial tests yttrium Y 90 basiliximab combined with BEAM chemotherapy before autologous hematopoietic stem cell transplantation in treating mature T-cell non-Hodgkin lymphoma. It aims to determine the side effects and best dose of this radioimmunotherapy approach.

What are the potential side effects?

Potential side effects include reactions related to radiation exposure from yttrium Y 90 basiliximab such as fatigue, nausea, and lowered blood counts. Chemotherapy may cause hair loss, mouth sores, increased risk of infection due to low blood cell counts, and possible damage to organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of therapy (stem cell infusion) to death from any cause, assessed up to 2 years post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of therapy (stem cell infusion) to death from any cause, assessed up to 2 years post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of therapy (stem cell infusion) to death from any cause, assessed up to 2 years post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of toxicities assessed using National Cancer Institute (NCI) CTCAE version 4.03

MTD of yttrium Y 90 basiliximab defined as the highest dose in which fewer than 33% of patients experience dose limiting toxicity attributable to study treatment, among those evaluable for toxicity

Secondary study objectives

Cumulative incidence of relapse/progression

Perinatal death

Overall survival

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (yttrium Y 90 basiliximab, BEAM, AHCT)Experimental Treatment8 Interventions

Patients receive yttrium Y 90 basiliximab IV on days -21 and -14, carmustine IV over 1-2 hours on days -7 and -6, cytarabine IV BID on days -5 to -2, etoposide IV BID on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplant on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carmustine

1990

Completed Phase 3

~1820

Etoposide

2010

Completed Phase 3

~2960

Cytarabine

2016

Completed Phase 3

~3330

Melphalan

2008

Completed Phase 3

~1500

Autologous Hematopoietic Stem Cell Transplantation

2017

Completed Phase 3

~2090

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Cutaneous T-Cell Non-Hodgkin Lymphoma (CTCL) include radioimmunotherapy, such as Yttrium Y 90 Basiliximab, which combines radioactive isotopes with monoclonal antibodies to specifically target and destroy cancer cells. This approach leverages the precision of monoclonal antibodies to deliver radiation directly to the tumor, minimizing damage to surrounding healthy tissue. This is particularly important for CTCL patients as it offers a targeted treatment option that can effectively reduce tumor burden while potentially limiting side effects compared to traditional chemotherapy. Other treatments may include systemic therapies like chemotherapy, which works by killing rapidly dividing cells, and targeted therapies that inhibit specific pathways essential for cancer cell survival.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

596 Previous Clinical Trials

1,923,517 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,980 Total Patients Enrolled

Jasmine Zain, MDPrincipal InvestigatorCity of Hope Medical Center

1 Previous Clinical Trials

Media Library

Basiliximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02342782 — Phase 1

Cutaneous T-Cell Non-Hodgkin Lymphoma Research Study Groups: Treatment (yttrium Y 90 basiliximab, BEAM, AHCT)

Cutaneous T-Cell Non-Hodgkin Lymphoma Clinical Trial 2023: Basiliximab Highlights & Side Effects. Trial Name: NCT02342782 — Phase 1

Basiliximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02342782 — Phase 1

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