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.
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: I. 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: I. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Given IV
Given IV
Given IV
Given IV
Given via infusion
Given SC or IV
Given IV
City of Hope Medical Center
Duarte, California, United States
RECRUITINGProgression free survival
Disease relapse or progression, or death from any cause, whichever occurs first. Will be calculated using the Kaplan-Meier method.
Time frame: From the start of treatment up to 5 years post transplant
Overall survival
Death from any cause. Will be calculated using the Kaplan-Meier method.
Time frame: From the start of treatment up to 5 years post transplant
Relapse or progression
Relapse or progression of Hodgkin lymphoma.
Time frame: From the start of treatment up to 5 years post transplant
Non-relapse mortality
Death from causes other than relapse or progression.
Time frame: From the start of treatment up to 5 years post transplant
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.
Time frame: Day -14 to day 100 post-transplant
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.
Time frame: Up to day 100 post transplant
Incidence of infection
Microbiologically documented infections will be reported by site of disease, date of onset, severity and resolution, if any.
Time frame: Day -14 to day 100 post-transplant
Rate of secondary myelodysplastic syndrome
Secondary MDS or AML post therapy
Time frame: From the start of treatment up to 5 years post transplant
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