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

Launched by CITY OF HOPE MEDICAL CENTER · Apr 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with Hodgkin lymphoma that has either not responded to previous treatments or has come back after treatment. The researchers are combining a special type of antibody, which is linked to a radioactive substance, with a specific chemotherapy regimen known as BEAM. This combination aims to help kill cancer cells and shrink tumors, making it easier for the body to recover and prepare for a stem cell transplant.

To be eligible for this trial, participants must be at least 18 years old, have a confirmed diagnosis of Hodgkin lymphoma, and meet certain health criteria, such as having a good performance status and a life expectancy of at least six months. Those who are pregnant or have certain other health conditions may not qualify. Participants can expect to undergo treatment that may help in managing their cancer while being closely monitored by the research team throughout the study. It's important for potential participants to discuss this option with their doctors to understand how it fits into their overall treatment plan.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria Informed Consent and Willingness to Participate 1. Documented informed consent of the participant and/or legally authorized representative.
• • - Assent, when appropriate, will be obtained per institutional guidelines Age Criteria, Performance status
• • 1. Age: ≥18 years
• • 2. Karnofsky performance status ≥ 70%
• • 3. Life expectancy ≥ 6 months Nature of Illness and Illness Related Criteria
• • 4. Histologically confirmed HL
• 5. 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
• • 6. 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.
• • 7. 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)
• • 8. Serum creatinine ≤ 1.5 mg/dL
• • 9. Creatinine clearance of ≥ 60 mL/min per 24 hour urine test
• • 10. Total bilirubin ≤ 1.5 X ULN (unless has Gilbert's disease)
• • 11. AST/SGOT ≤1.5 x ULN (except in cases where abnormal LFTs are due to involvement with HL)
• • 12. ALT/SGPT ≤ 1.5 x ULN (except in cases where abnormal LFTs are due to involvement with HL)
• • 13. Left ventricular ejection fraction (LVEF) ≥ 50%
• • 14. FEV1 \> 65% of predicted measured, or DLCO (diffusion capacity) ≥ 50% of predicted measured (corrected for hemoglobin).
• • Contraception
• • 15. 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).
• • Exclusion Criteria Prior and concomitant therapies
• • 1. Planned BV consolidation after AHCT
• • 2. Prior high dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation.
• • 3. 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.
• • 4. Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.
• • Other illnesses or conditions
• • 5. 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
• • 6. 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).
• • 7. Lymphocyte-predominant Hodgkin Lymphoma
• • 8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 90Y-basiliximab-DOTA.
• • 9. Persistent marrow involvement (\>10%) with HL after salvage cytoreductive therapy and before stem cell mobilization.
• • 10. BM harvest required to reach adequate cell dose for transplant.
• • 11. Active Hepatitis B or C viral infection or Hepatitis B surface antigen positive
• • 12. Positive Human Immunodeficiency Virus antibody, patients with undetectable HIV viral load with CD4 ≥ 300 and are on HAART medication are allowed
• • 13. Patients should not have any uncontrolled illness including ongoing or active infection.
• • 14. Patients with psychosocial circumstances or illnesses that preclude protocol participation (to be determined by P.I.)
• • 15. 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.
• • 16. 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
• • 17. 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.