Recruiting
Phase 2

Yttrium-90 & BEAM

Sponsor:

City of Hope Medical Center

Code:

NCT04871607

Conditions

Recurrent Hodgkin Lymphoma

Refractory Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Basiliximab

Carmustine

Cytarabine

Etoposide

Genetically Engineered Hematopoietic Stem Progenitor Cells

Study Details

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

Study ID

NCT04871607

Start date

Nov 2, 2021

Status verified date

Dec, 2025

Completion date

Oct 2, 2029

Anticipated

Primary completion date

Oct 2, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

1. Age: ≥18 years
2. Karnofsky performance status ≥ 70%
3. Life expectancy ≥ 6 months Nature of Illness and Illness Related Criteria
4. Histologically confirmed HL
5. 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
6. 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.
7. 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)
8. Serum creatinine ≤ 1.5 mg/dL
9. Creatinine clearance of ≥ 60 mL/min per 24 hour urine test
10. Total bilirubin ≤ 1.5 X ULN (unless has Gilbert's disease)
11. AST/SGOT ≤1.5 x ULN (except in cases where abnormal LFTs are due to involvement with HL)
12. ALT/SGPT ≤ 1.5 x ULN (except in cases where abnormal LFTs are due to involvement with HL)
13. Left ventricular ejection fraction (LVEF) ≥ 50%
14. FEV1 > 65% of predicted measured, or DLCO (diffusion capacity) ≥ 50% of predicted measured (corrected for hemoglobin).

Contraception
15. 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

1. Planned BV consolidation after AHCT
2. Prior high dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation.
3. 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.
4. Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.

Other illnesses or conditions
5. 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
6. 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).
7. Lymphocyte-predominant Hodgkin Lymphoma
8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 90Y-basiliximab-DOTA.
9. Persistent marrow involvement (>10%) with HL after salvage cytoreductive therapy and before stem cell mobilization.
10. BM harvest required to reach adequate cell dose for transplant.
11. Active Hepatitis B or C viral infection or Hepatitis B surface antigen positive
12. Positive Human Immunodeficiency Virus antibody, patients with undetectable HIV viral load with CD4 ≥ 300 and are on HAART medication are allowed
13. Patients should not have any uncontrolled illness including ongoing or active infection.
14. Patients with psychosocial circumstances or illnesses that preclude protocol participation (to be determined by P.I.)
15. 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.
16. 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
17. 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.

Study Design

Enrollment

33 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

Interventions

Basiliximab

Given IV

Carmustine

Given IV

Cytarabine

Given IV

Etoposide

Given IV

Genetically Engineered Hematopoietic Stem Progenitor Cells

Given via infusion

Recombinant Granulocyte Colony-Stimulating Factor

Given SC or IV

Yttrium Y 90 Basiliximab

Given IV

Primary outcome measure

  • Progression free survival [ Time Frame: From the start of treatment up to 5 years post transplant ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

Alex F. Herrera

More Information

Sponsor

City of Hope Medical Center

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-12-04.