Phase I/II Study of Yttrium-90 Labeled Anti-CD25 (a-Tac) Monoclonal Antibody Plus BEAM for Autologous Hematopoietic Cell Transplantation (AHCT) in Patients With Primary Refractory or Relapsed Hodgkin Lymphoma, the "a-Tac BEAM Regimen"
I. To determine the safety and feasibility of the autologous hematopoietic cell
transplantation (AHCT) regimen of Yttrium-90 (90Y) labeled anti-CD25 monoclonal antibody
(basiliximab), given in combination with standard dose(s) of BEAM in patients with primary
progressive or relapsed Hodgkin lymphoma (HL).
(Phase I) II. To determine the phase II dose (P2D) and characterize toxicities at each dose
level -including time course.
(Phase I) III. To evaluate hematological recovery in terms of neutrophil and platelet
(Phase I) IV. To estimate the radiation doses to the whole body and normal organs through
serial imaging studies.
(Phase I) V. To define biodistribution/extended pharmacokinetics of 111Indium
(In)-basiliximab and 90Y- basiliximab including terminal elimination, serum half-life
(t1/2), and area under the curve (AUC).
(Phase I) VI. Using the P2D defined in the Phase I study, to determine anti-tumor activity
of anti (a)Tac-BEAM as assessed by progression-free survival (PFS).
(Phase II) VII. To determine the overall response rate (ORR: complete remission [CR] +
partial remission [PR]) and response duration.
(Phase II) VIII. To estimate the overall survival, and non-relapse mortality (NRM) at
100-days and 1-year.
(Phase II) IX. To summarize toxicities by organ and severity, evaluating short and long-term
complications, including, delayed engraftment, infection, and myelodysplasia.
(Phase II) X. To descriptively compare the outcomes of patients treated on this protocol to
a comparable patient population treated with conventional BEAM for relapsed and refractory
(Phase II) OUTLINE: DOSIMETRY STUDY: Patients receive basiliximab intravenously (IV) and
indium In 111 basiliximab IV on day -21. Patients undergo indium In 111 imaging scans daily.
Patients with appropriate biodistribution continue on to treatment.
TREATMENT: Patients receive basiliximab IV and yttrium Y 90 basiliximab IV on day -14.
Patients also receive BEAM chemotherapy comprising carmustine IV over 2 hours on days -7 and
-6, etoposide IV over 4 hours and cytarabine IV over 2 hours twice daily (BID) on days -5 to
-2, and melphalan IV on day -1. Patients undergo autologous hematopoietic progenitor cell
infusion on day 0.
After completion of study treatment, patients are followed up at day 90-100, 180, 1 year,
1.5 years, and 2-5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
P2D of Yttrium-90 labeled basiliximab (phase I)
P2D is defined as the highest Yttrium-90 labeled basiliximab dose tested in which fewer than 33% of patients experience dose limiting toxicity (DLT) attributable to study treatment, among those evaluable for toxicity.
Up to 18 months
City of Hope Medical Center
United States: Federal Government
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