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

Phase 2

Recruiting

• Conditions: Recurrent Hodgkin Lymphoma; Refractory Hodgkin Lymphoma
• Interventions: 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

• Registration Number: NCT04871607
• Lead Sponsor: City of Hope Medical Center

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) ...

Detailed Description

PRIMARY OBJECTIVE:

I. 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:
...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-04
• Study Start: 2021-11-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2027-10-02
• Study Completion: 2027-10-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)	Basiliximab	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.
Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)	Genetically Engineered Hematopoietic Stem Progenitor Cells	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.
Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)	Recombinant Granulocyte Colony-Stimulating Factor	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.
Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)	Yttrium Y 90 Basiliximab	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.
Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)	Carmustine	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.
Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)	Cytarabine	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.
Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)	Etoposide	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.

Primary Outcome Measures

Name	Time	Method
Progression free survival	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival	From the start of treatment up to 5 years post transplant	Death from any cause. Will be calculated using the Kaplan-Meier method.
Relapse or progression	From the start of treatment up to 5 years post transplant	Relapse or progression of Hodgkin lymphoma.
Non-relapse mortality	From the start of treatment up to 5 years post transplant	Death from causes other than relapse or progression.
Incidence of toxicities and adverse events	Day -14 to day 100 post-transplant	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 versio...
Time to hematopoietic recovery	Up to day 100 post transplant	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.
Incidence of infection	Day -14 to day 100 post-transplant	Microbiologically documented infections will be reported by site of disease, date of onset, severity and resolution, if any.
Rate of secondary myelodysplastic syndrome	From the start of treatment up to 5 years post transplant	Secondary MDS or AML post therapy

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States