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Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)

NCT00644371 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-27

No results posted yet for this study

Summary

To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.

Conditions

Interventions

DRUG

Ibritumomab Tiuxetan (Zevalin)

Conditioning Regimen 1. Rituximab, 250 mg/m2 on days -21 and -14. 2. Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14. Chemotherapy: * Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion. * Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion. Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months: * Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8. * Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion. * Melphalan 70 mg/m2/day on day -2 as a 15-min infusion.

Sponsors & Collaborators

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

    lead OTHER

Principal Investigators

  • Dolores Caballero, MD · Hospital Clínico Universitario de Salamanca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-02-21
Completion
2013-02-04

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00644371 on ClinicalTrials.gov