Alemtuzumab Use (MabCampath®) in Hematopoietic Transplant of Unrelated Donor With Reduced Intensity Conditioning

Phase 2

Terminated

• Conditions: Graft Versus Host Disease
• Interventions: Drug: Alemtuzumab

• Registration Number: NCT00781781
• Lead Sponsor: CABYC

Brief Summary

The purpose of this study is to analyze the results of incidence and severity of acute and chronic GVHD, (see addendum II) and of disease free survival with Alemtuzumab use (MabCampath®) in haematopoietic transplant of unrelated donor with reduced intensity conditioning.

Detailed Description

Each patient will be assigned to one of the two dosing schedules and total dose of drug envisaged in the study. The assignation to conventional or reduced Alemtuzumab (MabCampath) dose will be done depending on the age and risk of suffering GVHD, in function of variables coming from general experience.

High risk of GVHD criteria:

Gender incompatibility: male patient of female donor. HLA incompatibility: non identical high resolution typing in HLA A, B, C, DRB1, DQB1 (identity less than 10/10 alleles by high resolution) Age of patient more or equal than 55 years

Conventional doses in high risk (at least one criterion of GVHD high risk):

100 mg de Alemtuzumab IV total dose in 5, 20 mg fractions, days -8, -7, -6, -5 and -4.

Reduced dose in low risk cases (no criteria of GVHD high risk):

50 mg de Alemtuzumab IV total dose en 5 fractions of 10 mg, days -5, -4, -3, -2 and -1.

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2008-08
• Status Verified: 2008-10
• Study First Submitted: 2008-10-28
• Study First Submitted QC: 2008-10-28
• Study First Posted: 2008-10-29
• Study Completion: 2011-12
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

• Liver (≥ x3 UNL), kidney (GF <40ml/min), cardiac (LVEF <40%) or respiratory (DLCO & FVC <40% of expected) function tests impairment.
• HIV injection.
• Absence of signed informed consent.
• Progressive disease previous to transplant or not fulfilling the above mentioned response criteria.
• Other co-morbidities that contraindicate CT.
• Pregnant and/or breast-feeding women or with pregnancy risk by inadequate contraception.
• Life expectancy <6 months.
• Mental or psychiatric deficiency impeding adequate understanding and consent to therapy
• Hypersensitivity as shown by anaphylactic reaction to any of the DRUGS used in the trial.
• Active infectious process.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Alemtuzumab	High risk patients (at least one GVHD high risk criterion): Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive).
2	Alemtuzumab	Low Risk patients (no GVHD high risk criterion): Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive).

Primary Outcome Measures

Name	Time	Method
Analyze the results of incidence and severity of acute and chronic GVHD	3 years

Trial Locations

Locations (10)

Hospital Clinic i Provincial.; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Clinico de Valencia; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Hospital Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Vall de Hebron; 🇪🇸 Barcelona, Spain

Hospital La Princesa; 🇪🇸 Madrid, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

ICO Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Morales Meseguer; 🇪🇸 Murcia, Spain