RecruitingPhase 2NCT04871607

Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma

A Phase 2 Trial of Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy (aTac-BEAM) Conditioning for Autologous Hematopoietic Cell Transplantation (AHCT) in Patients With Primary Refractory or Relapsed Hodgkin Lymphoma


Sponsor

City of Hope Medical Center

Enrollment

33 participants

Start Date

Nov 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trials studies the effects of yttrium-90 labeled anti-CD25 monoclonal antibody combined with BEAM chemotherapy conditioning in treating patients with Hodgkin lymphoma that does not response to treatment (refractory) or has come back (relapsed). Yttrium-90-labeled anti-CD25 is an antibody (proteins made by the immune system to fight infections) that is attached to a radioactive substance and may kill cancer cells and shrink tumors. Chemotherapy drugs, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a radioactive antibody treatment (Y-90 anti-CD25) combined with standard high-dose chemotherapy before a stem cell transplant in patients with high-risk Hodgkin lymphoma that has relapsed or not responded to initial treatment. The radioactive antibody targets a specific protein (CD25) found on Hodgkin lymphoma cells. **You may be eligible if...** - You are 18 or older and have confirmed Hodgkin lymphoma - Your lymphoma is high-risk: it relapsed quickly, came back after immunotherapy (PD-1 blockade or brentuximab), has spread outside lymph nodes, or you have B symptoms (fever, sweats, weight loss) - You have already had stem cells collected for transplant (at least 2 million CD34+ cells/kg) - You are in reasonably good health (Karnofsky score 70% or higher, life expectancy over 6 months) - Your kidney, liver, and heart function meet the study requirements **You may NOT be eligible if...** - Your lymphoma is not confirmed Hodgkin lymphoma - You have not yet had your stem cells collected - You have serious organ dysfunction (kidney, liver) - You have active infections or other serious illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBasiliximab

Given IV

DRUGCarmustine

Given IV

DRUGCytarabine

Given IV

DRUGEtoposide

Given IV

BIOLOGICALGenetically Engineered Hematopoietic Stem Progenitor Cells

Given via infusion

BIOLOGICALRecombinant Granulocyte Colony-Stimulating Factor

Given SC or IV

BIOLOGICALYttrium Y 90 Basiliximab

Given IV


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT04871607


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