Radioactive antibody combo aims to beat back tough hodgkin lymphoma
NCT ID NCT04871607
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a new approach for people with Hodgkin lymphoma that has not responded to treatment or has come back. It combines a radioactive antibody (yttrium-90 labeled anti-CD25) with standard BEAM chemotherapy before a stem cell transplant. The goal is to see if this combination can improve how long people stay cancer-free. The study plans to enroll 33 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Yttrium-90 labeled anti-CD25 monoclonal antibody (basiliximab) combined with BEAM chemotherapy (carmustine, etoposide, cytarabine, melphalan)
- What this could lead to
- If successful, this could improve the chance of long-term remission for people with Hodgkin lymphoma that has not responded to or returned after standard treatment.
- What could go wrong
- This is a small, early-phase trial (33 people) with no control group, so results may not apply broadly. The treatment includes high-dose chemo and radiation, which can cause serious side effects like infections and organ damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2021
- Expected to finish
-
Oct 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Recurrent Hodgkin lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Blood cancer transplant study tests safer GVHD prevention
- Can a weekly drug combo outsmart resistant lymphoma?
- Immunotherapy combo aims to stop hodgkin lymphoma relapse after transplant
- Stem cell transplant study seeks best way to prevent immune attack
- New hope for kids with Hard-to-Treat cancers: targeted drug shows promise
- New combo therapy aims to outsmart tough hodgkin lymphoma