NCT04871607 · City of Hope Medical Center
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma
What this study is about
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).
View original scientific description
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.
Interventions
BIOLOGICAL
Basiliximab
Given IV
DRUG
Carmustine
Given IV
DRUG
Cytarabine
Given IV
DRUG
Etoposide
Given IV
BIOLOGICAL
Genetically Engineered Hematopoietic Stem Progenitor Cells
Given via infusion
BIOLOGICAL
Recombinant Granulocyte Colony-Stimulating Factor
Given SC or IV
BIOLOGICAL
Yttrium Y 90 Basiliximab
Given IV
Primary outcome measures
Progression free survival
Time frame: From the start of treatment up to 5 years post transplant
Disease relapse or progression, or death from any cause, whichever occurs first. Will be calculated using the Kaplan-Meier method.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Informed Consent and Willingness to Participate 1. Documented informed consent of the participant and/or legally authorized representative. \- 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)
- Serum creatinine ≤ 1.5 mg/dL
- Creatinine clearance of ≥ 60 mL/min per 24 hour urine test
- Total bilirubin ≤ 1.5 X ULN (unless has Gilbert's disease)
- AST/SGOT ≤1.5 x ULN (except in cases where abnormal LFTs are due to involvement with HL)
- ALT/SGPT ≤ 1.5 x ULN (except in cases where abnormal LFTs are due to involvement with HL)
- Left ventricular ejection fraction (LVEF) ≥ 50%
- FEV1 \> 65% of predicted measured, or DLCO (diffusion capacity) ≥ 50% of predicted measured (corrected for hemoglobin). Contraception
- 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).
Exclusion criteria
- Prior and concomitant therapies
- 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.)
- Pregnant women are excluded from this study because 90Y-basiliximab/DOTA is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother 90Y-basiliximab/DOTA, breastfeeding should be discontinued if the mother is treated with 90Y-basiliximab/DOTA.
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. Noncompliance
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
- Eligibility should be confirmed per institutional policies.
Where
- Duarte, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 4, 2025 · Source of record for eligibility and locations