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Sponsored by: |
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea |
Information provided by: | Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea |
ClinicalTrials.gov Identifier: | NCT00646750 |
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.
Condition | Intervention | Phase |
Non-Hodgkin's Lymphoma |
Drug: Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan) |
Phase II |
MedlinePlus related topics: | Lymphoma |
ChemIDplus related topics: | Cytarabine Cytarabine hydrochloride Etoposide Melphalan Rituximab Etoposide phosphate Ibritumomab tiuxetan Melphalan hydrochloride Sarcolysin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Autologous Transplantation of Haematopoietic Stem Cells With Conditioning Including Zevalin + BEAM to Patients Suffering From Refractory Large B-Cell Diffuse Lymphom |
Estimated Enrollment: | 42 |
Study Start Date: | January 2008 |
Arms | Assigned Interventions |
1: Experimental
BEAM preceded by Ybritumomab Tiuxetan (Zevalin)
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Drug: Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)
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. |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Abide by at least one of the following conditions:
Additionally, to be able to undergo haematopoietic stem cell transplantation, all patients should satisfy the requirements of routine clinical practice, i.e.:
Exclusion Criteria:
Contact: Dolores Caballero, MD | +34618834923 | cabarri@usal.es |
Contact: Ana M Mendez | +34942203450 | geltamo@humv.es |
Spain | |||||
Hospital Universitario de Alicante | Recruiting | ||||
Alicante, Spain | |||||
Contact: Pascual Fernández, MD | |||||
H. de la Santa Creu i Sant Pau | Recruiting | ||||
Barcelona, Spain | |||||
Contact: Javier Briones, MD | |||||
Instituto Catalán de Oncología, | Recruiting | ||||
Barcelona, Spain | |||||
Contact: Eva González, MD | |||||
H. Reina Sofía | Recruiting | ||||
Córdoba, Spain | |||||
Contact: Antonio Torres, MD | |||||
H.U. La Paz | Recruiting | ||||
Madrid, Spain | |||||
Contact: Miguel Canales, MD | |||||
H.U. Gregorio Marañón, | Recruiting | ||||
Madrid, Spain | |||||
Contact: Jorge Gayoso, MD | |||||
Clínica Puerta de Hierro, | Recruiting | ||||
Madrid, Spain | |||||
Contact: José Antonio García-Marco, MD | |||||
H.U. La Princesa | Recruiting | ||||
Madrid, Spain | |||||
Contact: Reyes Arranz, MD | |||||
M.D. Anderson Internacional | Recruiting | ||||
Madrid, Spain | |||||
Contact: José Francisco Tomás, MD | |||||
H.U. 12 de Octubre, | Recruiting | ||||
Madrid, Spain | |||||
Contact: Carlos Grande, MD | |||||
H.U. Virgen de la Arrixaca | Recruiting | ||||
Murcia, Spain | |||||
Contact: José M Moraleda, MD | |||||
H. Morales Messeguer | Recruiting | ||||
Murcia, Spain | |||||
Contact: Inmaculada Heras, MD | |||||
H. Clínico Universitario de Salamanca | Recruiting | ||||
Salamanca, Spain | |||||
Contact: Dolores Caballero, MD | |||||
Principal Investigator: Caballero, MD | |||||
H.U. Marqués de Valdecilla | Recruiting | ||||
Santander, Spain | |||||
Contact: Eulogio Conde, MD | |||||
H.U. La Fe | Recruiting | ||||
Valencia, Spain | |||||
Contact: Isidro Jarque, MD | |||||
Spain, Asturias | |||||
H.U. Central de Asturias, Oviedo | Recruiting | ||||
Oviedo, Asturias, Spain | |||||
Contact: Teresa Bernal del Castillo, MD | |||||
Spain, Canarias | |||||
H.Universitario de Canarias | Recruiting | ||||
Santa Cruz de Tenerife, Canarias, Spain | |||||
Contact: Miguel Hernández, MD | |||||
Spain, Navarra | |||||
Clínica Universitaria de Navarra | Recruiting | ||||
Pamplona, Navarra, Spain | |||||
Contact: Carlos Panizo, MD |
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea |
Principal Investigator: | Javier Briones, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Principal Investigator: | Dolores Caballero, MD | Hospital Clínico Universitario de Salamanca |
Responsible Party: | Hospital de la Santa Creu i Sant Pau, Servicio de Hematología ( Dr. Javier Briones ) |
Study ID Numbers: | GELTAMO-Z-BEAM LDGGB, EudraCT No.: 2007-003198 - 22 |
First Received: | March 17, 2008 |
Last Updated: | March 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00646750 |
Health Authority: | Spain: Spanish Agency of Medicines |
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