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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT02366663
Phase
PHASE3
Status
Terminated

Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 90-Yttrium Ibritumomab tiuxetan — RADIATION
    0.4 mCi/kg given IV
  • Carmustine — DRUG
    Given IV
  • Etoposide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IV
  • Melphalan — DRUG
    Given IV
  • Autologous Hematopoietic Stem Cell Transplant — PROCEDURE
    Autologous Hematopoietic Stem Cell Transplantation (ASCT)
  • Rituximab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jan 31, 2015
Status verified
Feb 2018
Primary completion
Oct 31, 2016
Completion
Oct 31, 2016

Study Design

Enrollment
3 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (ZBEAM)
    Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
  • Active Comparator: Arm II (BEAM)
    Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.

Primary Outcome Measure

Overall Survival [ Time Frame: Measured from randomization to date of death or last follow up date, whichever occurs first, for up to 5 years post randomization ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAMemorial Sloan Kettering Cancer Center· New York, NY

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