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

NCT04871607 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 20420NCI-2021-03073P30CA033572P50CA107399
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Hodgkin Lymphoma; Refractory Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Disease relapse or progression, or death from any cause, whichever occurs first. Will be calculated using the Kaplan-Meier method.

  From the start of treatment up to 5 years post transplant

Secondary Outcomes (7)

• Overall survival

  From the start of treatment up to 5 years post transplant

• Relapse or progression

  From the start of treatment up to 5 years post transplant

• Non-relapse mortality

  From the start of treatment up to 5 years post transplant

• Incidence of toxicities and adverse events

  Day -14 to day 100 post-transplant

• Time to hematopoietic recovery

  Up to day 100 post transplant

Study Arms (1)

Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)

EXPERIMENTAL

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.

Biological: Basiliximab; Drug: Carmustine; Drug: Cytarabine; Drug: Etoposide; Biological: Genetically Engineered Hematopoietic Stem Progenitor Cells; Biological: Recombinant Granulocyte Colony-Stimulating Factor; Biological: Yttrium Y 90 Basiliximab

Interventions

Etoposide DRUG

Given IV

Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP-16, VP-16-213, VP16

Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)

Basiliximab BIOLOGICAL

Given IV

Also known as: SDZ-CHI-621, Simulect

Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)

Carmustine DRUG

Given IV

Also known as: BCNU, Becenum, Becenun, BiCNU, Bis(chloroethyl) Nitrosourea, Bis-Chloronitrosourea, Carmubris, Carmustin, Carmustinum, FDA 0345, N,N'-Bis(2-chloroethyl)-N-nitrosourea, Nitrourean, Nitrumon, SK 27702, SRI 1720, WR-139021

Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)

Cytarabine DRUG

Given IV

Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453

Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)

Genetically Engineered Hematopoietic Stem Progenitor Cells BIOLOGICAL

Given via infusion

Also known as: Genetically Engineered HSPCs

Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)

Recombinant Granulocyte Colony-Stimulating Factor BIOLOGICAL

Given SC or IV

Also known as: Recombinant Colony-Stimulating Factor 3, rhG-CSF

Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)

Yttrium Y 90 Basiliximab BIOLOGICAL

Given IV

Also known as: 90Y Basiliximab, Yttrium Y 90-DOTA-Basiliximab

Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Assent, when appropriate, will be obtained per institutional guidelines Age Criteria, Performance status
• Age: ≥18 years
• Karnofsky performance status ≥ 70%
• Life expectancy ≥ 6 months Nature of Illness and Illness Related Criteria
• Histologically confirmed HL
• 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 106 CD34 cells/kg of autologous hematopoietic progenitor cells (HPC-A) by apheresis.
• Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to ≤ grade 2 (CTCAE v5).
• Clinical Laboratory and Organ Function Criteria (To be performed prior to Day 1 of protocol therapy)

You may not qualify if:

• Planned BV consolidation after AHCT
• Prior high dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation.
• Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records by the Radiation Oncology PI.
• Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.
• Other illnesses or conditions
• Myelodysplasia or any active malignancy other than HL, or \< 5 years remission from any other prior malignancy, except non-melanoma skin cancer, localized prostate cancer or localized cervical cancer
• Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia is excluded. This includes, but is not limited to, del(5), del(7), del(11).
• Lymphocyte-predominant Hodgkin Lymphoma
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 90Y-basiliximab-DOTA.
• Persistent marrow involvement (\>10%) with HL after salvage cytoreductive therapy and before stem cell mobilization.
• BM harvest required to reach adequate cell dose for transplant.
• Active Hepatitis B or C viral infection or Hepatitis B surface antigen positive
• Positive Human Immunodeficiency Virus antibody, patients with undetectable HIV viral load with CD4 ≥ 300 and are on HAART medication are allowed
• Patients should not have any uncontrolled illness including ongoing or active infection.
• Patients with psychosocial circumstances or illnesses that preclude protocol participation (to be determined by P.I.)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Basiliximab; Carmustine; Cytarabine; Etoposide; pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Alex F Herrera

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: November 2, 2021
• Primary Completion (Estimated): October 2, 2029
• Study Completion (Estimated): October 2, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)