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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

Information source: King's College Hospital NHS Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Intervention: Fludarabine (Drug); Busulphan (Drug); Thymoglobuline (Anti-thymocyte globulin [rabbit]) - Genzyme (Drug); Haematopoietic stem cell infusion (Procedure)

Phase: Phase 2

Status: Terminated

Sponsored by: King's College Hospital NHS Trust

Official(s) and/or principal investigator(s):
Ghulam J Mufti, MB, DM, FRCP, FRCPath, Principal Investigator, Affiliation: King's College London

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.

Clinical Details

Official title: Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome and Acute Myeloid Leukaemia Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Treatment related mortality to Day 100

Secondary outcome:

Incidence of single or multi-organ acute toxicity

Incidence of graft failure/rejection

Incidence of acute graft-versus-host disease

Incidence of systemic infections

EBV activation

Overall survival

Disease free survival/relapse risk

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Patient Selection 1. Availability of a HLA compatible sibling donor 2. Age >18 years 3. Myelodysplastic Syndromes with IPSS Intermediate-2 or High. 4. Poor risk acute myeloid leukaemia, de novo or transformed from MDS 5. Ineligibility for standard conditioning allograft due to age or co-existing morbidities Donor selection 1. Related donors compatible for HLA-A, B, C, DRB1 and DQB1 by molecular typing. Exclusion Criteria: Patient selection 1. Cardiac insufficiency requiring treatment or symptomatic coronary artery disease. 2. Hepatic disease, with AST > 2 times normal. 3. Severe hypoxaemia, pO2 < 70 mm Hg, with decreased DLCO < 70% of predicted; or mild hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 60% of predicted. 4. Impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight). 5. Patients who have received previous treatment with Thymoglobuline 6. HIV-positive patients. 7. Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants. 8. Life expectancy severely limited by diseases other than MDS or MPD. 9. Serious concurrent untreated infection 10. Patients with limited life expectancy for other reasons 11. Serious psychiatric/ psychological disorders 12. Absence of /inability to provide informed consent Donor selection 1. Age >75 years, unless independently assessed to be medically fit to donate 2. Donors who for any reason are unable to tolerate the leukapheresis procedure and cannot undergo anaesthesia for marrow harvest. 3. Donors who are HIV-positive, or hepatitis B or C PCR positive. 4. Donors who are medically unsuitable to donate

Locations and Contacts

King's College Hospital NHS Foundation Trust, London SE5 9RS, United Kingdom
Additional Information

Starting date: June 2007
Last updated: August 16, 2011

Page last updated: August 23, 2015

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