Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-cell Difusse Lymphom

Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Study ID
NCT00646750
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan) — DRUG
    Day -21: rituximab. 250 mg/m2 iv Day -14: rituximab. 250 mg/m2 plus Ybritumomab Tiuxetan (Zevalin)(0.4 mCi/kg maximum dose 32 mCi). Days -6 to -1: BEAM regimen as follows BCNU: 300 mg/m2 over 2 hours, day -6. ARAC: 200 mg/m2/12 hours over 12 hours, days -5 through -2. VP16: 200 mg/m2/day over 2 hours, days -5 through -2. Melphalan: 140 mg/m2/day over 15 minutes, day -1.

Study Details

To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin) administration in the conditioning treatment of patients with refractory large B-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells.

Key Dates

Start date
Jan 31, 2008
Status verified
Feb 2016
Primary completion
Feb 28, 2010
Completion
Jun 30, 2012

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    BEAM preceded by Ybritumomab Tiuxetan (Zevalin)

Primary Outcome Measure

Disease clinical response to treatment - complete response rate. [ Time Frame: Pre-transplantation; post-transplantation (one week following Ybritumomab Tiuxetan (Zevalin) administration); And three months post-transplantation ]

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