Clinical Trial · NCT02366663

BEAM vs. 90-Yttrium Ibritumomab Tiuxetan (Zevalin®)/BEAM With ASCT for Relapsed DLBCL

Overview

This randomized phase III trial studies 90-yttrium ibritumomab tiuxetan and combination chemotherapy compared with combination chemotherapy alone before stem cell transplant in treating patients with diffuse large b-cell non-Hodgkin lymphoma that has returned after a period of improvement. Radioactive substances linked to monoclonal antibodies, such as 90-yttrium ibritumomab tiuxetan, can bind to cancer cells and give off radiation which may help kill cancer cells. Drugs used in chemotherapy, such as carmustine, etoposide phosphate, cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether 90-yttrium ibritumomab tiuxetan and BEAM before a stem cell transplant are more effective than BEAM alone in treating patients with diffuse large b-cell non-Hodgkin lymphoma.

Sponsor

City of Hope Medical Center

Phase

Phase 3

Contacts

Amrita Y. Krishnan MD, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02366663

Drug / Compound

ibritumomab tiuxetan

Isotope(s):

Target(s):

cd20

Ligand Class: Antibodies

Chelator: tiuxetan

Eligibility

Inclusion

Marrow involvement less than 25% at transplantation, no limitation on blood counts (low platelet count allowed).
Patients must have chemo-sensitive disease achieving at least partial response (Cheson 2007 criteria) to last chemotherapy.
Patients with CD20 positive diffuse large B-cell lymphoma as confirmed by a pathological biopsy report.
Patients with adequate autologous stem cell collection for transplantation (target \>= 2.5 x 10\^6 CD34+ cells/kg).
Patients who are candidates for autologous stem-cell transplantation due to primary refractory or first relapse of disease.

Exclusion

Two or more relapses after initial response to induction chemotherapy.
Patients who have had prior radiation to the lung will be excluded from the study, although mediastinal irradiation will be permitted if minimal lung is in the treatment volume.
Patients who have received \>500cGy radiation to the kidneys will be excluded from the study.
KPS \< 70.
Active CNS disease involvement.
High-grade transformation from earlier diagnosis of low-grade lymphoma. Patients with "De Novo" Transformed DLBCL, defined as DLBCL only on lymph node biopsy and a discordant marrow with para-trabecular small cells at first diagnosis of lymphoma, are eligible if adherent to all other selection criteria.
Prior autologous or allogeneic HSCT.
Chemo-refractory disease as determined by less than partial response (Cheson 2007 Criteria) to last chemotherapy.
Prior radioimmunotherapy.