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Allogeneic Stem Cell Transplantation for Children With CML

NCT02707393 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-04-15

No results posted yet for this study

Summary

In children and adolescents with chronic myeloid leukaemia (CML) stem cell transplantation (SCT) may be a valid alternative to the life-long treatment with tyrosinkinase inhibitors (TKI). This trial aims to evaluate the use of a reduced intensity conditioning regimen (RIC), consisting of fludarabine, melphalan and thiotepa in order to minimize transplant related mortality and toxic late effects. Strict post-transplant monitoring and reintroduction of TKI as well as donor lymphocyte infusions (DLI) in case of relevant residual disease are part of the protocol.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Fludarabine

infusion

DRUG

Thiotepa

infusion

DRUG

Melphalan

infusion

DRUG

ATG

infusion

DRUG

Cyclosporine A

infusion, orally if possible

DRUG

Mycophenolate mofetil

infusion

BIOLOGICAL

bone marrow or peripheral blood stem cells

infusion

Sponsors & Collaborators

  • St. Anna Kinderkrebsforschung

    lead OTHER

Principal Investigators

  • Susanne Matthes, MD · St. Anna Kinderspital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • Austria
  • Czechia
  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT02707393 on ClinicalTrials.gov