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Recurrent Hodgkin LymphomaPhase 2NCT04871607

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

A Phase 2 study testing Basiliximab, Carmustine and Cytarabine in people with Recurrent Hodgkin Lymphoma and Refractory Hodgkin Lymphoma, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Basiliximab, Carmustine and Cytarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
2 Nov 2021to 2 Oct 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Alex F. Herrera, 626-256-4673 ext. 62405, aherrera@coh.org

    Alex F. Herrera

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Trial of Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy (aTac-BEAM) Conditioning for Autologous Hematopoietic Cell Transplantation (AHCT) in Patients With Primary Refractory or Relapsed Hodgkin Lymphoma

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Evaluate the anti-lymphoma activity of the aTac-carmustine (BCNU), etoposide, cytarabine (cytosine arabinoside), and melphalan (BEAM) regimen as conditioning for autologous hematopoietic cell transplantation (AHCT); assessed by 2-year progression-free survival (PFS).

SECONDARY OBJECTIVES:

  1. Estimate the overall survival (OS) probability and cumulative incidence of relapse/progression, and non-relapse mortality (NRM) at 100-days, 1-year and 2-years.

II. Summarize toxicities by type, frequency, severity, attribution, time course and duration.

III. Evaluate short and long-term complications, including: delayed engraftment (neutrophil and platelet), infection, and myelodysplasia (MDS).

EXPLORATORY OBJECTIVES:

  1. Evaluate potential changes in Hodgkin lymphoma biological markers of patients treated with 90Y basiliximab BEAM via analyses of serial blood samples.

II. Assess the potential association between pre-AHCT CD25 expression levels and post-AHCT outcomes.

OUTLINE:

Patients receive 'cold' basiliximab intravenously (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 once daily (QD) and cytarabine IV over 2 hours twice daily (BID) or QD on days -5 to -2, and melphalan IV over 1 hours on day -1. Patients then receive hematopoietic progenitor cell apheresis (HPC-A) product via infusion on day 0. Beginning day 5, patients receive granulocyte colony-stimulating factor (G-CSF) (or biosimilar) subcutaneously (SC) or IV until absolute neutrophil count (ANC) > 500 for 3 consecutive days or according to the treating physician's best clinical judgement.

After completion of study treatment, patients are followed up at 30 days, up to 2 years for response, and up to 5 years for survival.

Being tested
Basiliximab, Carmustine, Cytarabine, Etoposide, Genetically Engineered Hematopoietic Stem Progenitor Cells
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BasiliximabBiological

    Also called SDZ-CHI-621, Simulect

    Given IV

  • CarmustineDrug

    Also called BCNU, Becenum, Becenun, BiCNU

    Given IV

  • CytarabineDrug

    Also called .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

    Given IV

  • EtoposideDrug

    Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar

    Given IV

  • Genetically Engineered Hematopoietic Stem Progenitor CellsBiological

    Also called Genetically Engineered HSPCs

    Given via infusion

  • Recombinant Granulocyte Colony-Stimulating FactorBiological

    Also called Recombinant Colony-Stimulating Factor 3, rhG-CSF

    Given SC or IV

  • Yttrium Y 90 BasiliximabBiological

    Also called 90Y Basiliximab, Yttrium Y 90-DOTA-Basiliximab

    Given IV

Study groups in NCT04871607
Study groupRoleWhat they receive
Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)ExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Disease relapse or progression, or death from any cause, whichever occurs first.

    Will be calculated using the Kaplan-Meier method.

    Measured: From the start of treatment up to 5 years post transplant

Secondary outcomes (7)

  1. Overall survival

    Death from any cause. Will be calculated using the Kaplan-Meier method.

    Measured: From the start of treatment up to 5 years post transplant

  2. Relapse or progression

    Relapse or progression of Hodgkin lymphoma.

    Measured: From the start of treatment up to 5 years post transplant

  3. Non-relapse mortality

    Death from causes other than relapse or progression.

    Measured: From the start of treatment up to 5 years post transplant

  4. Incidence of toxicities and adverse events

    Toxicity information recorded will include the type, severity, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity. Toxicities will be recorded using both the Bearman criteria and the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 scale.

    Measured: Day -14 to day 100 post-transplant

  5. Time to hematopoietic recovery

    Time to neutrophil recovery will be the first of three consecutive days of ≥ 500 neutrophils/μL following the expected nadir. Time to platelet engraftment will be the first day of the first of three consecutive daily laboratory values when the platelet count is ≥20,000/μL, without a platelet transfusion in the previous seven days.

    Measured: Up to day 100 post transplant

  6. Incidence of infection

    Microbiologically documented infections will be reported by site of disease, date of onset, severity and resolution, if any.

    Measured: Day -14 to day 100 post-transplant

  7. Rate of secondary myelodysplastic syndrome

    Secondary MDS or AML post therapy

    Measured: From the start of treatment up to 5 years post transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2021
  2. Study start2 Nov 2021
  3. Primary completion2 Oct 2029 (estimated)
  4. Study completion2 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04871607
Sponsor's protocol ID
20420
Other IDs
NCI-2021-03073, 20420, P30CA033572, P50CA107399
Status last verified
Dec 2025
First submitted
29 Apr 2021
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Basiliximab, Carmustine and Cytarabine in people with Recurrent Hodgkin Lymphoma and Refractory Hodgkin Lymphoma, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: From the start of treatment up to 5 years post transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04871607.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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