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.
• \- Assent, when appropriate, will be obtained per institutional guidelines Age Criteria, Performance status
• Age: ≥18 years
• Karnofsky performance status ≥ 70%
• Life expectancy ≥ 6 months Nature of Illness and Illness Related Criteria
• Histologically confirmed HL
• 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
• 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.
• 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)
• Serum creatinine ≤ 1.5 mg/dL
• Creatinine clearance of ≥ 60 mL/min per 24 hour urine test
⁃ Total bilirubin ≤ 1.5 X ULN (unless has Gilbert's disease)
⁃ AST/SGOT ≤1.5 x ULN (except in cases where abnormal LFTs are due to involvement with HL)
⁃ ALT/SGPT ≤ 1.5 x ULN (except in cases where abnormal LFTs are due to involvement with HL)
⁃ Left ventricular ejection fraction (LVEF) ≥ 50%
⁃ FEV1 \> 65% of predicted measured, or DLCO (diffusion capacity) ≥ 50% of predicted measured (corrected for hemoglobin).
⁃ Contraception
⁃ 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).