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A RANDOMIZED CONTROLLED STUDY IN NEWLY DIAGNOSED SEVERE APLASTIC ANEMIA PATIENTS RECEIVING ANTITHYMOCYTE GLOBULIN (ATG), CYCLOSPORIN A, WITH OR WITHOUT G-CSF

Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)



Sponsors

Lead Sponsor

 European Group for Blood and Marrow Transplantation

Collaborators

 CHUGAI sanofi-aventis


Source

European Group for Blood and Marrow Transplantation

Oversight Info

Has Dmc

Yes


Brief Summary

The purpose of this study is to examine the effect of G-CSF on disease free survival and overall survival in aplastic anaemia patients who also receive ATG and Cyclosporin A.

Detailed Description

Open label, randomized, controlled study of G-CSF, ATG and Cyclosporin A versus ATG and Cyclosporin A. Subjects will be evaluated for hematologic response through day 240. Subjects who do not demonstrate a partial or complete remission by day 120 will be randomized to receive either a second course of ATG or continue their current regimen. Subjects who do demonstrate a partial or complete remission will continue their current regimen through day 240 or maintenance of a complete remission for 30 days. The last day of study treatment will be day 240.

Overall Status

Terminated

Start Date

2001-03-01

Completion Date

2010-11-01

Primary Completion Date

2008-06-01

Phase

Phase 3

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Failure free survival
day 240

Secondary Outcome

Measure

Time Frame

Haematological response
day 240
Severe Infections
day 240
Benefit of addition of G-CSF
day 240
Complete remission
day 120
Relapse rate
2year
Blood count
day 240
Severity of the disease
day 365
Retreatment with ATG
day 240
Safety
6year

Enrollment

205

Condition

 Aplastic Anaemia

Intervention

Intervention Type

Drug

Intervention Name

 G-CSF

Description

Yes/no addition of G-CSF

Arm Group Label

No G-CSF, No 2nd ATG

No G-CSF, yes 2nd ATG

Yes G-CSF, No 2nd ATG

Yes G-CSF, Yes 2nd ATG



Intervention Type

Drug

Intervention Name

 Early retreatment with ATG

Description

Yes/no early retreatment with ATG

Arm Group Label

No G-CSF, No 2nd ATG

No G-CSF, yes 2nd ATG

Yes G-CSF, No 2nd ATG

Yes G-CSF, Yes 2nd ATG




Eligibility

Criteria

Inclusion Criteria: - Severe or very severe aplastic anemia - Less than 6 months from diagnosis of severe aplastic anemia by bone marrow biopsy - Ethical - Before randomization is done the subject or legally acceptable representative must give written informed consent for participation in the study Exclusion Criteria: - Eligibility for an HLA-matched sibling donor transplant - Prior therapy with ATG - Cyclosporin A <4 weeks before enrollment - Treatment with G-CSF <2 weeks before enrollment - Other growth factors <4 weeks before enrollment - Diagnosis of Fanconi anemia, dyskeratosis congenita or congenital bone marrow failure syndrome - Evidence of myelodysplastic disease - Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma) - Subjects who have infection, hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that death is imminent - Subject is pregnant (e.g. positive HCG test) or is breast feeding

Gender

All

Minimum Age

N/A

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

André Tichelli, Prof. MD.
Principal Investigator
University Hospital, Basel, Switzerland

Location

Facility

University Hospital
Pilsen Czech Republic
CHU Angers
Angers France
Avicenne Hospital
Bobigny France
University Hospital
Brest France
CHU Clemenceau
Caen France
CHU de Caen
Caen France
Henri Mondor
Creteil France
CHU Limoges
Limoges France
Paoli-Calmettes Institute
Marseille France
CHU Montpellier
Montpellier France
CHU Caremeau
Nimes France
St. Antoine
Paris France
St. Louis Hospital
Paris France
CHU Reims
Reims France
CHU Toulouse
Toulouse France
Bretonneau Hospital
Tours France
G. Roussy Institute
Villejuf France
Benjamin Franklin Hospital
Berlin Germany
Charite Hospital
Berlin Germany
Evangelisches Waldkrankenhaus
Berlin Germany
Evangelisches Krankenhaus Diakonie
Bremen Germany
University Hospital
Cologne Germany
University Hospital Carl Gustav Carus
Dresden Germany
St. Johannes-Hospital
Duisburg Germany
University Hospital Heinrich Heine
Düsseldorf Germany
Universitätsklinik
Essen Germany
University Hospital
Frankfurt Germany
University Hospital Georg August
Göttingen Germany
Marien Hopistal
Hagen Germany
University Hospital
Halle Germany
Asklepios Klinik Altona
Hamburg Germany
Hannover Medical School
Hannover Germany
University Hospital
Heidelberg Germany
Universitäts Klinikum
Ludwigshaven Germany
Sana Klinikum
Lübeck Germany
Harlachin
München Germany
Klinkum Rechts der Isar
München Germany
Krakenhaus München Schwabing
München Germany
Klinikum Nord
Nürnberg Germany
Klinikum Oldenburg
Oldenburg Germany
Brüderkrankenhaus St. Josef
Paderborn Germany
Klinikum Ernst von Bergmann
Potsdam Germany
University Hospital
Regensburg Germany
University Hospital
Rostock Germany
Klinikum Stuttgart
Stuttgart Germany
University Clinic Tübingen
Tübingen Germany
University Hospital Ulm
Ulm Germany
Deutsche Klinik für Diagnostik
Wiesbaden Germany
University Hospital
Wiesbaden Germany
Helios Klinikum Wuppertal
Wuppertal Germany
Athens General Pediatric Hospital
Athens Greece
University Hospital
Patras Greece
Gaslini Children's Hospital
Genova Italy
San Martino
Genova Italy
San Raffaele Hospital
Milan Italy
University Hospital
Padova Italy
Groningen University Hospital
Groningen Netherlands
Leiden University Medical Centre
Leiden Netherlands
Erasmus MC
Rotterdam Netherlands
Lund Unversity
Lund Sweden
Huddinge University Hospital
Stockholm Sweden
University Hospital
Basel Switzerland
Hopitaux Universitaires de Geneve
Geneva Switzerland
Monklands Hospital
Airdrie United Kingdom
Heartlands Hospital
Birmingham United Kingdom
Bristol Haematology & Oncology Centre
Bristol United Kingdom
Royal Cornwall Hospitals
Cornwall United Kingdom
The Leeds Teaching Hospitals
Leeds United Kingdom
St George's Hospital/ St George's University of London
London Sw17 0RE United Kingdom
St. Bartholomew's Hospital
London United Kingdom
Wishaw General
Wishaw United Kingdom

Location Countries

Country

Czech Republic

France

Germany

Greece

Italy

Netherlands

Sweden

Switzerland

United Kingdom



Verification Date

2010-07-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse

 Anemia,  Anemia, Aplastic

Secondary Id

41980964

Number Of Arms

4

Intervention Browse

Mesh Term

Cyclosporins

Cyclosporine

Lenograstim



Arm Group

Arm Group Label

No G-CSF, No 2nd ATG

Arm Group Type

Active Comparator

Description

Patients randomised not to receive G-CSF (alongside ATG and CSA) and to not receive early retreatment in case of no response.


Arm Group Label

No G-CSF, yes 2nd ATG

Arm Group Type

Active Comparator

Description

Patients randomised not to receive G-CSF (alongside ATG and CSA) but they do receive early retreatment in case of no response.


Arm Group Label

Yes G-CSF, No 2nd ATG

Arm Group Type

Active Comparator

Description

Patients randomised to receive G-CSF (alongside ATG and CSA) and to not receive early retreatment in case of no response.


Arm Group Label

Yes G-CSF, Yes 2nd ATG

Arm Group Type

Active Comparator

Description

Patients randomised to receive G-CSF (alongside ATG and CSA) and to receive early retreatment in case of no response.



Firstreceived Results Date

N/A

Why Stopped

Ceased production of the study drug, Lymphoglobulin. Recruitment of patients onto the trial was too slow.

Acronym

SAA-G-CSF

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Single Group Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

July 14, 2010

Study First Submitted Qc

July 15, 2010

Study First Posted

July 16, 2010

Last Update Submitted

April 2, 2015

Last Update Submitted Qc

April 2, 2015

Last Update Posted

April 3, 2015


ClinicalTrials.gov processed this data on August 31, 2018

Conditions

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Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.

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