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Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML) Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin

NCT00915811 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-08-17

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and feasibility of conditioning with fludarabine, busulphan and thymoglobuline in patients with myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative disorders (MDS/MPD) or acute myeloid leukaemia (AML) undergoing haematopoietic stem cell allograft with granulocyte colony-stimulating factor (G-CSF)-mobilised peripheral blood stem cells (PBSC) (or bone marrow) from HLA compatible sibling donors.

Conditions

Interventions

DRUG

Fludarabine

Fludarabine 30mg/m2 intravenously daily on days -9 to -5 inclusive of stem cell infusion.

DRUG

Busulphan

Busulphan 0.8mg/kg intravenously 6 hourly on days -4 and -3 of stem cell infusion.

DRUG

Thymoglobuline (Anti-thymocyte globulin [rabbit]) - Genzyme

Thymoglobuline will be given intravenously over a minimum of 6 hours for the first two doses and 4 hours for the subsequent doses. Acute side effects of ATG appear to be reduced if a very low dose is given for the first injection. Thymoglobuline 0.5mg/kg iv on day -4, 1.5mg/kg/day on day -3; and 2mg/kg/day iv on day -2 to -1 inclusive.

PROCEDURE

Haematopoietic stem cell infusion

The source of stem cells will be PBSC wherever possible. Patients whose donors decline or are unable to donate PBSC will be transplanted with marrow cells.

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Ghulam J Mufti, MB, DM, FRCP, FRCPath · King's College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United Kingdom

Study Locations

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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 NCT00915811 on ClinicalTrials.gov