Actively Recruiting
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma
Led by City of Hope Medical Center · Updated on 2025-12-04
33
Participants Needed
1
Research Sites
413 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial 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). 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
Official Title
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide documented informed consent and assent if appropriate
- Age 18 years or older
- Karnofsky performance status of 70% or higher
- Expected life expectancy of at least 6 months
- Histologically confirmed Hodgkin lymphoma
- High risk relapsed or refractory Hodgkin lymphoma with any of the following: B symptoms at relapse, extranodal disease at relapse, primary refractory disease, relapse within 1 year after frontline therapy, not in complete remission at transplant, or relapse after PD1 blockade or brentuximab vedotin initial therapy
- Collection of at least 2.0 x 10^6 CD34 cells/kg autologous hematopoietic progenitor cells by apheresis
- Recovery from non-hematologic toxicities of salvage chemotherapy to grade 2 or lower
- Serum creatinine 1.5 mg/dL or less
- Creatinine clearance 60 mL/min or higher
- Total bilirubin at or below 1.5 times upper limit of normal unless Gilbert's disease
- AST/SGOT at or below 1.5 times upper limit of normal unless related to Hodgkin lymphoma
- ALT/SGPT at or below 1.5 times upper limit of normal unless related to Hodgkin lymphoma
- Left ventricular ejection fraction 50% or higher
- FEV1 greater than 65% predicted or DLCO 50% or higher corrected for hemoglobin
- Agreement to use effective contraception or abstain from heterosexual activity during the study and for six months after last treatment if of childbearing potential
You will not qualify if you...
- Planned brentuximab vedotin consolidation after transplant
- Prior high dose chemotherapy with autologous or allogeneic stem cell transplant
- Significant prior radiation to critical organs
- Receiving other investigational agents or concurrent chemotherapy, biological, or radiation therapy
- Active myelodysplasia or other active malignancy except certain localized cancers or remission over 5 years
- Cytogenetic abnormalities predictive of myelodysplasia
- Lymphocyte-predominant Hodgkin lymphoma
- Allergic reaction history to compounds similar to 90Y-basiliximab-DOTA
- Persistent marrow involvement over 10% with Hodgkin lymphoma after salvage therapy
- Bone marrow harvest needed to reach transplant cell dose
- Active Hepatitis B or C infection or Hepatitis B surface antigen positive
- Positive HIV antibody unless controlled with CD4 count ≥300 and on HAART
- Uncontrolled illness or active infection
- Psychosocial or medical conditions preventing participation
- Pregnancy or breastfeeding
- Any condition deemed unsafe by the investigator
- Inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here