Pilot Study of Reduced Intensity Haematopoietic Stem Cell... | NCT00915811

Studies
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

Sponsor

King's College Hospital NHS Trust

Status

Terminated

Last Update Posted

Aug 17, 2011Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Myelodysplastic Syndromes
Leukemia, Myeloid, Acute

Interventions

Fludarabine
Busulphan
Thymoglobuline (Anti-thymocyte globulin [rabbit]) - Genzyme
Haematopoietic stem cell infusion

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

FB ATG is now a standard for sib allo MDS patients

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 5, 2009

First Submission Date that Met QC Criteria

Jun 5, 2009

First Posted Date

Jun 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2011

Last Update Posted Date

Aug 17, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FBATG	Experimental	Haematopoietic stem cell transplantation utilising conditioning with Fludarabine, Busulphan and Thymoglobuline	Drug: Fludarabine Drug: Busulphan Drug: Thymoglobuline (Anti-thymocyte globulin [rabbit]) - Genzyme Procedure: Haematopoietic stem cell infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fludarabine	Drug	Fludarabine 30mg/m2 intravenously daily on days -9 to -5 inclusive of stem cell infusion.	FBATG

Measure	Description	Time Frame
Treatment related mortality to Day 100		Days 28, 56 and 100

Measure	Description	Time Frame
Incidence of single or multi-organ acute toxicity		Days 28, 56 and 100
Incidence of graft failure/rejection		Days 28, 56 and 100
Incidence of acute graft-versus-host disease

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient Selection

Availability of a HLA compatible sibling donor
Age >18 years
Myelodysplastic Syndromes with IPSS Intermediate-2 or High.
Poor risk acute myeloid leukaemia, de novo or transformed from MDS
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

Cardiac insufficiency requiring treatment or symptomatic coronary artery disease.
Hepatic disease, with AST > 2 times normal.
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.
Impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight).
Patients who have received previous treatment with Thymoglobuline
HIV-positive patients.
Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
Life expectancy severely limited by diseases other than MDS or MPD.
Serious concurrent untreated infection
Patients with limited life expectancy for other reasons
Serious psychiatric/ psychological disorders
Absence of /inability to provide informed consent

Donor selection

Age >75 years, unless independently assessed to be medically fit to donate
Donors who for any reason are unable to tolerate the leukapheresis procedure and cannot undergo anaesthesia for marrow harvest.
Donors who are HIV-positive, or hepatitis B or C PCR positive.
Donors who are medically unsuitable to donate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ghulam J Mufti, MB, DM, FRCP, FRCPath	King's College London	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
King's College Hospital NHS Foundation Trust		London		SE5 9RS	United Kingdom

ID	Term
D009190	Myelodysplastic Syndromes
D015470	Leukemia, Myeloid, Acute

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
C024352	fludarabine
D002066	Busulfan
D000961	Antilymphocyte Serum

Ancestor Terms

ID	Term
D002072	Butylene Glycols
D006018	Glycols
D000438	Alcohols
D009930	Organic Chemicals
D008698	Mesylates
D000476	Alkanesulfonates
D017738	Alkanesulfonic Acids
D000473	Alkanes
D006839	Hydrocarbons, Acyclic
D006838	Hydrocarbons
D013451	Sulfonic Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds
D007106	Immune Sera
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D001688	Biological Products
D045424	Complex Mixtures

ID	Type	Description	Link
REC - 06/Q0703/208
EudraCT - 2006-004452-20