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
City of Hope Medical Center
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) 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.
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: 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 l…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalBasiliximab
Given IV
- DrugCarmustine
Given IV
- DrugCytarabine
Given IV
- DrugEtoposide
Given IV
- BiologicalGenetically Engineered Hematopoietic Stem Progenitor Cells
Given via infusion
- BiologicalRecombinant Granulocyte Colony-Stimulating Factor
Given SC or IV
- BiologicalYttrium Y 90 Basiliximab
Location
- City of Hope Medical CenterDuarte, California