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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by IRCCS Policlinico S. Matteo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Italian Association for Pediatric Hematology Oncology
Information provided by:
IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT00934557
First received: July 7, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Paediatric Patients Affected by Haematological Malignancies and Eligible to Undergo HSCT From an Unrelated Volunteer
Drug: ATG Fresenius
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multi-Centre Prospective Randomized Study on the Use of Two Different Doses of Rabbit Anti-Thymocyte Globulin for GVHD Prevention in Paediatric Patients With Haematological Malignancies Given an Unrelated Donor Haematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • incidence and severity of acute GVHD [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • incidence of chronic GVHD •relapse rate •TRM •EFS •incidence of infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: March 2008
Arms Assigned Interventions
Experimental: Good prognosis/mismatched donor/BM Drug: ATG Fresenius
Experimental: Good prognosis/mismatched donor/PB Drug: ATG Fresenius
Experimental: Poor prognosis/matched donor/BM Drug: ATG Fresenius
Experimental: Poor prognosis/matched donor/PB Drug: ATG Fresenius
Experimental: Poor prognosis/mismatched donor/BM Drug: ATG Fresenius
Experimental: Poor prognosis/mismatched donor/PB Drug: ATG Fresenius
Experimental: Good prognosis/matched donor/BM Drug: ATG Fresenius
Experimental: Good prognosis/matched donor/PB Drug: ATG Fresenius

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934557

Contacts
Contact: Franco Locatelli, Professor +390382502607 f.locatelli@smatteo.pv.it

Locations
Italy
Franco Locatelli Recruiting
Pavia, Italy, 27100
Contact: Franco Locatelli, Professor    +390382502607    f.locatelli@smatteo.pv.it   
Sub-Investigator: Maria Ester Bernardo, MD         
Sub-Investigator: Marco Zecca, MD         
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Italian Association for Pediatric Hematology Oncology
  More Information

No publications provided

Responsible Party: Professor Franco Locatelli, Foundation IRCCS Policlinico San Matteo, Pavia Italy
ClinicalTrials.gov Identifier: NCT00934557     History of Changes
Other Study ID Numbers: ProfGVHD1
Study First Received: July 7, 2009
Last Updated: July 7, 2009
Health Authority: Italy: Agenzia Italiana del Farmaco

Additional relevant MeSH terms:
Neoplasms
Graft vs Host Disease
Hematologic Neoplasms
Immune System Diseases
Neoplasms by Site
Hematologic Diseases
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014