Randomized Study of ATG for Graft Versus Host Disease (GVHD) Prevention in Paediatric Patients Given an Unrelated Donor Stem Cell Transplantation

NCT00934557 | Unknown Phase 3 DMC

• 1 other identifier: ProfGVHD1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Paediatric patients affected by haematological malignancies and eligible to undergo HSCT from an unrelated volunteer will be stratified according to the degree of compatibility with their donor, the source of haematopoietic stem cells employed (BM vs. PB) and the disease phase (good vs. poor prognosis). In particular, on the basis of compatibility with their donor, patients will be allocated to 2 different arms: those transplanted from an unrelated donor either perfectly matched or with a single allelic disparity at one of the HLA loci (i.e. A, B, C, and DrB1) vs. those transplanted from an unrelated donor either with 2 allelic disparities or with an antigenic disparity at the HLA loci (i.e. A, B, C, and DrB1). Patients enrolled in the study will be randomized to receive ATG (Fresenius) at a dosage of either 30 mg/Kg (10 mg/Kg on days -4, -3 and -2) or 15 mg/Kg (5 mg/Kg on days -4, -3 and -2). Good prognosis patients are defined as follows: ALL in 1st CR; ALL in 2nd CR belonging to S2 group; AML in 1st CR, AML in 2nd CR and relapsed more than 6 months after stopping therapy; NHL in 2nd CR; Ph+ CML in 1st CP; refractory cytopenia. Poor prognosis patients are defined as follows: ALL in 2nd CR belonging to the S3-S4 group; ALL in ≥ 3rd CR; AML in 2nd CR and relapsed less than 6 months after stop therapy; secondary AML; NHL in 3rd CR; Ph+ CML in 2nd CP, as well as in AP; RAEB, RAEB-t, JMML.

Conditions

Paediatric Patients Affected by Haematological Malignancies and Eligible to Undergo HSCT From an Unrelated Volunteer

Outcome Measures

Primary Outcomes (1)

• incidence and severity of acute GVHD

  12 months

Secondary Outcomes (1)

• • incidence of chronic GVHD •relapse rate •TRM •EFS •incidence of infection

  12 months

Study Arms (8)

Good prognosis/mismatched donor/BM

EXPERIMENTAL

Drug: ATG Fresenius

Good prognosis/mismatched donor/PB

EXPERIMENTAL

Drug: ATG Fresenius

Poor prognosis/matched donor/BM

EXPERIMENTAL

Drug: ATG Fresenius

Poor prognosis/matched donor/PB

EXPERIMENTAL

Drug: ATG Fresenius

Poor prognosis/mismatched donor/BM

EXPERIMENTAL

Drug: ATG Fresenius

Poor prognosis/mismatched donor/PB

EXPERIMENTAL

Drug: ATG Fresenius

Good prognosis/matched donor/BM

EXPERIMENTAL

Drug: ATG Fresenius

Good prognosis/matched donor/PB

EXPERIMENTAL

Drug: ATG Fresenius

Interventions

ATG Fresenius DRUG

Good prognosis/mismatched donor/BM

Eligibility Criteria

• Age: 1 Year - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Unrelated donor selected using high-resolution molecular typing of HLA-A, B, C and DrB1 loci, perfectly matched or with a single allelic disparity at one of the HLA loci or with 2 allelic disparities and with an antigenic disparity at the HLA loci;
• Age comprised between 0 and 19 years;
• Life-expectancy of at least 2 months;
• Use of G-CSF mobilized PB- or BM-derived haematopoietic stem cells

You may not qualify if:

• Unrelated donor selected using high-resolution molecular typing of HLA-A, B, C and DrB1 loci, with more than one antigenic disparity or more than 2 allelic disparities at the HLA loci;
• Previous allogeneic HSCT;
• Cord blood as source of haematopoietic stem cells;
• Previous treatment with rabbit ATG in the last 3 months before HSCT;
• History of allergic reactions to rabbit ATG;
• Absence of written informed consent.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• Italian Association for Pediatric Hematology Oncology: collaborator

Study Sites (1)

Franco Locatelli

Pavia, Pavia, 27100, Italy

RECRUITING

Related Publications (1)

• Locatelli F, Bernardo ME, Bertaina A, Rognoni C, Comoli P, Rovelli A, Pession A, Fagioli F, Favre C, Lanino E, Giorgiani G, Merli P, Pagliara D, Prete A, Zecca M. Efficacy of two different doses of rabbit anti-T-lymphocyte globulin to prevent graft-versus-host disease in children with haematological malignancies transplanted from an unrelated donor: a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1126-1136. doi: 10.1016/S1470-2045(17)30417-5. Epub 2017 Jul 10.

  PMID: 28705454 DERIVED

Central Study Contacts

Franco Locatelli, Professor

CONTACT

+390382502607; f.locatelli@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 8, 2009
• Study Start: March 1, 2008
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

IT (1)