Ofatumumab as Part of Reduced Intensity Conditioning (RIC) Regimen for Patients With High Risk Chronic Lymphocytic Leukemia (CLL) Undergoing Allogeneic Hematopoietic Cell Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2017

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Ofatumumab

We plan to add five doses of ofatumumab to the standard conditioning regimen (fludarabine + melphalan). Ofatumumab will be administered on days -20 (300 mg), -13 (2000 mg), -6 (2000 mg), +1 (1000 mg) and +8 (1000 mg) of the transplantation (day 0 being the day of the hematopoietic cell infusion). If the patient requires donor lymphocyte infusions within 3 years after the procedure, these infusions will also include one administration of 300 mg of ofatumumab, followed by a 1000 mg dose, 7 days later).

Trial Locations (9)

Unknown

Hospital Germans Trias i Pujol, Badalona

Hospital Vall d'Hebron, Barcelona

Institut Catala d'Oncologia, L'Hospitalet de Llobregat

Hospital La Princesa, Madrid

Hospital Puerta de Hierro, Madrid

Hospital Central de Asturias, Oviedo

Hospital Clinico, Valencia

Hospital La Fe, Valencia

08025

Hospital de la Santa Creu Sant Pau, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Grupo Espanol de trasplantes hematopoyeticos y terapia celular

OTHER

NCT01455051 - Ofatumumab as Part of Reduced Intensity Conditioning (RIC) Regimen for Patients With High Risk Chronic Lymphocytic Leukemia (CLL) Undergoing Allogeneic Hematopoietic Cell Transplantation | Biotech Hunter | Biotech Hunter