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T&B Depletion Non Malignant

NCT01810926 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2013-03-14

No results posted yet for this study

Summary

• The primary aim of the present trial is to assess in a randomized fashion the benefit on standard graft-versus-host disease (GVHD) prophylaxis of the addition of ATG-Fresenius S ® in transplants from matched related donors (MRD) and of anti-CD20 rituximab in transplants from matched unrelated donors (MUD). Both safety and efficacy of the treatment will be assessed, in particular in respect to the clinical status of the patient, i.e. prevention of graft failure and chronic GvHD and of Ebstein Barr virus (EBV) viremia for MUD patients.

The conditioning proposed combines myeloablative drugs with a favorable safety profile such as treosulfan, thiotepa (Tepadina®) and fludarabine with the intent to reduce the traditional immediate and late toxicity of busulfan and cyclophosphamide.

Conditions

Interventions

BIOLOGICAL

polyclonal antibody

iv at a dose of 5 mg/kg within 8 hours on day -4,-3,-2 (total dose 15 mg/kg)

DRUG

Rituximab

single infusion of200 mg/m2 on day -1

DRUG

Treosulfan

iv at a dose of 14 g/m² within 120 minutes on day -7, - 6, -5 (total dose of 42 g/m²)

DRUG

Fludarabine

iv at a dose of 30 mg/ m² within 30 minutes on day -7, -6, -5,-4,-3 after treosulfan

DRUG

Thiotepa

iv at a dose of 8 mg/kg on day - 3 divided into 2 infusions at 12 hrs intervals

DRUG

Cyclosporine A

iv at a dose of 3 mg/kg/day starting from day -1 and a dose adjustment will be done to obtain plasma levels of 150-250 ng/mL

DRUG

Methotrexate

iv at a dose of 15 mg/m2 on day +1, at a dose of 10 mg/m2 on day + 3 and + 6

DRUG

Methotrexate

iv at a dose of 15 mg/m2 on day +1, at a dose of 10 mg/m2 on day + 3 and + 6 and at a dose of 10 mg/m2 on day +11

Sponsors & Collaborators

  • University of Milano Bicocca

    collaborator OTHER

  • medac GmbH

    collaborator INDUSTRY

  • Fresenius AG

    collaborator INDUSTRY

  • Franco Locatelli

    lead OTHER

Principal Investigators

  • Franco Locatelli, Prof · Bambino Gesù Hospital and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-08-31
Completion
2016-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
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 NCT01810926 on ClinicalTrials.gov