Clinical Trial Results:
Prophylaxis of chronic graft-versus-host disease (cGvHD) with or without anti-thymocyte-globulin (ATG) prior allogeneic peripheral stem cell transplantation from HLA-identical siblings after myeloablative conditioning in patients with acute leukemia: a randomized phase III-study
Summary
|
|
EudraCT number |
2005-005719-83 |
Trial protocol |
DE IT ES |
Global end of trial date |
07 May 2014
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
01 May 2022
|
First version publication date |
01 May 2022
|
Other versions |
|
Summary report(s) |
Medical journal article Supplementary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
ATG Family Study
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Department of Stem Cell Transplantation, University Medical Center Eppendorf
|
||
Sponsor organisation address |
Martinistraße, 52, Hamburg, Germany, 20246
|
||
Public contact |
Francesca Bonifazi, Institute of Hematology and Clinical Oncology "L. and A. Seràgnoli", +39 0512143853, francesca.bonifazi@unibo.it
|
||
Scientific contact |
Nicolaus Kröger, Bone Marrow Transplantation, University Hospital Hamburg-Eppendorf, +49 40428034850, nkroeger@uke.uni-hamburg.de
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
30 Jun 2015
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
07 May 2014
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To demonstrate superiority of ATG over Non-ATG in preventing cGvHD after PBSCT, the cumulative incidence of cGvHD in patients with and without ATG administration was compared using competing risk cumulative incidence survival analysis.
|
||
Protection of trial subjects |
Insurance coverage for participating patients is provided by the Randomization and Data Management Office through the insurance companies. For Italy: Gerling Konzern
|
||
Background therapy |
Standard GVHD prohylaxis was with Cyclosporine and Methotrexate; the study added in the experimental arm ATG Fresenius, administered ad doses of 10 mg/kg BW on days -3, -2, and -1 before PBSCT via central venous catheter (total cumulative dose: 30 mg/kg BW) | ||
Evidence for comparator |
Cyclosporineand Methotrexate (comparator) was considered the standard option in the EBMT-ELN recommendation (Ruutu T. et al. – Bone Marrow Transplantation 2013) | ||
Actual start date of recruitment |
16 Nov 2006
|
||
Long term follow-up planned |
Yes
|
||
Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
2 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Spain: 21
|
||
Country: Number of subjects enrolled |
Germany: 31
|
||
Country: Number of subjects enrolled |
Italy: 99
|
||
Country: Number of subjects enrolled |
Israel: 10
|
||
Worldwide total number of subjects |
161
|
||
EEA total number of subjects |
151
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
161
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||||||||||
Recruitment
|
|||||||||||||||||||
Recruitment details |
Male and female patients, 18 – 65 years of age, suffering from ALL or AML in complete remission. Availability of an HLA-identical sibling as a peripheral blood stem cell donor. | ||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||
Screening details |
Patients with left ventricular ejection fraction < 30 %, Total bilirubin, SGPT or SGOT > 5 times upper the normal level, Creatinine clearance < 30 ml/min, DLCO < 35 % and/or receiving supplementary continuous oxygen. | ||||||||||||||||||
Pre-assignment period milestones
|
|||||||||||||||||||
Number of subjects started |
161 | ||||||||||||||||||
Number of subjects completed |
161 | ||||||||||||||||||
Period 1
|
|||||||||||||||||||
Period 1 title |
overall trial (overall period)
|
||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||||
Blinding implementation details |
Not applicable
|
||||||||||||||||||
Arms
|
|||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||
Arm title
|
Treatment with ATG | ||||||||||||||||||
Arm description |
Experimental arm adding ATG to the standard GVHD prophylaxis with CSA and MTX | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
ATG Fresenius
|
||||||||||||||||||
Investigational medicinal product code |
L04AA03
|
||||||||||||||||||
Other name |
ANTI-HUMAN – T – LINPHCYTE IMMUNOGLOBULIN SERUM CONCENTRATE
|
||||||||||||||||||
Pharmaceutical forms |
Concentrate for solution for infusion
|
||||||||||||||||||
Routes of administration |
Infusion
|
||||||||||||||||||
Dosage and administration details |
Administered ad doses of 10 mg/kg BW on days -3, -2, and -1 before PBSC transplant (total cumulative dose: 30 mg/kg BW)
|
||||||||||||||||||
Investigational medicinal product name |
Busilvex/Busulfan
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Concentrate for solution for infusion, Tablet
|
||||||||||||||||||
Routes of administration |
Intravenous use, Oral use
|
||||||||||||||||||
Dosage and administration details |
Busulfan was given at a total dose of 16 mg/kg BW orally or in form of Busilvex® at a dose of 12.8 mg/kg intravenously and it was administered from day -9 to day -6 at a dose of 4 mg/kg BW (orally) or 3.2 mg/kg BW (intravenously) per day. The preferred application of busulfan, however, was Busilvex® intravenously. Busilvex® was administered intravenously via a central venous catheter. The dose of Busilvex® was 0.8 mg/kg of ideal body weight or actual body weight, whichever is lower, administered as a two hour infusion every six hours for four days for a total of 16 doses, starting on day -9 to day -6. For obesive or severely obesive patients Busilvex® was administered based on adjusted ideal body weight.
|
||||||||||||||||||
Investigational medicinal product name |
Cyclophosphamide
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Powder for infusion
|
||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||
Dosage and administration details |
Cyclophosphamide at a dose of 120 mg/kg body weight was given intravenously via a central venous catheter on day -4 and -3 at 60 mg/kg BW per day for a total dose of 120 mg/kg BW.
|
||||||||||||||||||
Investigational medicinal product name |
Mesna
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Solution for infusion
|
||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||
Dosage and administration details |
Mesna to prevent hemorrhagic cystitis was used according to the local practice.
|
||||||||||||||||||
Investigational medicinal product name |
VP-16 (Etoposide)
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Concentrate for solution for infusion
|
||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||
Dosage and administration details |
Etoposide (VP-16) was given to TBI/Cyclophosphamide or Busulfan/Cyclophosphamide at a dose of 30 - 45 mg/kg, which were given intravenously.
|
||||||||||||||||||
Investigational medicinal product name |
Cyclosporine A
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Concentrate for solution for infusion, Tablet
|
||||||||||||||||||
Routes of administration |
Intravenous use, Oral use
|
||||||||||||||||||
Dosage and administration details |
Cyclosporine A was started at a dose of 3 mg/kg BW per day as continuous infusion, starting on day -1, according to the local standard policy. Cyclosporine A was switched orally, 3 mg/kg b.i.d. when tolerating oral medications, in the absence of GvHD.
|
||||||||||||||||||
Investigational medicinal product name |
Methotrexate
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Solution for infusion
|
||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||
Dosage and administration details |
Methotrexate was given on day 1 at a dose of 15 mg/m², and at a dose of 10 mg/m² on day 3, day 6, and day 11 intravenously. In case of severe mucositis and high bilirubin level the dose of methotrexate was adjusted according to the local policy.
|
||||||||||||||||||
Arm title
|
Non ATG | ||||||||||||||||||
Arm description |
Standard arm where patients received the standard GVHD prophylaxis with CSA and MTX | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Busilvex/Busulfan
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Concentrate for solution for infusion, Tablet
|
||||||||||||||||||
Routes of administration |
Intravenous use, Oral use
|
||||||||||||||||||
Dosage and administration details |
Busulfan was given at a total dose of 16 mg/kg BW orally or in form of Busilvex® at a dose of 12.8 mg/kg intravenously and it was administered from day -9 to day -6 at a dose of 4 mg/kg BW (orally) or 3.2 mg/kg BW (intravenously) per day. The preferred application of busulfan, however, was Busilvex® intravenously. Busilvex® was administered intravenously via a central venous catheter. The dose of Busilvex® was 0.8 mg/kg of ideal body weight or actual body weight, whichever is lower, administered as a two hour infusion every six hours for four days for a total of 16 doses, starting on day -9 to day -6. For obesive or severely obesive patients Busilvex® was administered based on adjusted ideal body weight.
|
||||||||||||||||||
Investigational medicinal product name |
Cyclophosphamide
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Powder for infusion
|
||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||
Dosage and administration details |
Cyclophosphamide at a dose of 120 mg/kg body weight was given intravenously via a central venous catheter on day -4 and -3 at 60 mg/kg BW per day for a total dose of 120 mg/kg BW.
|
||||||||||||||||||
Investigational medicinal product name |
Mesna
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Solution for infusion
|
||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||
Dosage and administration details |
Mesna to prevent hemorrhagic cystitis was used according to the local practice.
|
||||||||||||||||||
Investigational medicinal product name |
VP-16 (Etoposide)
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Concentrate for solution for infusion
|
||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||
Dosage and administration details |
Etoposide (VP-16) was given to TBI/Cyclophosphamide or Busulfan/Cyclophosphamide at a dose of 30 - 45 mg/kg, which were given intravenously.
|
||||||||||||||||||
Investigational medicinal product name |
Cyclosporine A
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Concentrate for solution for infusion, Tablet
|
||||||||||||||||||
Routes of administration |
Intravenous use, Oral use
|
||||||||||||||||||
Dosage and administration details |
Cyclosporine A was started at a dose of 3 mg/kg BW per day as continuous infusion, starting on day -1, according to the local standard policy. Cyclosporine A was switched orally, 3 mg/kg b.i.d. when tolerating oral medications, in the absence of GvHD.
|
||||||||||||||||||
Investigational medicinal product name |
Methotrexate
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Solution for infusion
|
||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||
Dosage and administration details |
Methotrexate was given on day 1 at a dose of 15 mg/m², and at a dose of 10 mg/m² on day 3, day 6, and day 11 intravenously. In case of severe mucositis and high bilirubin level the dose of methotrexate was adjusted according to the local policy.
|
||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment with ATG
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Experimental arm adding ATG to the standard GVHD prophylaxis with CSA and MTX | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Non ATG
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Standard arm where patients received the standard GVHD prophylaxis with CSA and MTX | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis sets
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Randomized and treated patients
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Randomized and treated patients
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Treatment with ATG
|
||
Reporting group description |
Experimental arm adding ATG to the standard GVHD prophylaxis with CSA and MTX | ||
Reporting group title |
Non ATG
|
||
Reporting group description |
Standard arm where patients received the standard GVHD prophylaxis with CSA and MTX | ||
Subject analysis set title |
Randomized and treated patients
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Randomized and treated patients
|
|
||||||||||
End point title |
Cumulative Incidence of cGVHD | |||||||||
End point description |
Comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic peripheral blood stem cell transplantation from HLA-identical siblings with or without antithymocyte globulin according to the revised Seattle criteria of Lee et al.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
The primary endpoint of the study was the cumulative incidence of chronic GVHD at 2 years.
|
|||||||||
|
||||||||||
Statistical analysis title |
Cumulative incidence analyses | |||||||||
Statistical analysis description |
Cumulative incidence analyses were performed with the use of NCSS statistical software, version 9, and R statistical software, version 2.10.1 (cmprsk package)
|
|||||||||
Comparison groups |
Treatment with ATG v Non ATG
|
|||||||||
Number of subjects included in analysis |
155
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
superiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
Regression, Cox | |||||||||
Confidence interval |
|
||||||||||
End point title |
Relapse | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
2 years
|
|||||||||
|
||||||||||
Statistical analysis title |
Relapse analysis | |||||||||
Comparison groups |
Treatment with ATG v Non ATG
|
|||||||||
Number of subjects included in analysis |
155
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
superiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
Regression, Cox | |||||||||
Confidence interval |
|
||||||||||
End point title |
Relapse-free Survival | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
2 years
|
|||||||||
|
||||||||||
Statistical analysis title |
Relapse-free Survival analysis | |||||||||
Comparison groups |
Treatment with ATG v Non ATG
|
|||||||||
Number of subjects included in analysis |
155
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
superiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
Regression, Cox | |||||||||
Confidence interval |
|
||||||||||
End point title |
Overall Survival | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
2 years
|
|||||||||
|
||||||||||
Statistical analysis title |
Overall Survival analysis | |||||||||
Comparison groups |
Treatment with ATG v Non ATG
|
|||||||||
Number of subjects included in analysis |
155
|
|||||||||
Analysis specification |
Post-hoc
|
|||||||||
Analysis type |
superiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
Regression, Cox | |||||||||
Confidence interval |
|
||||||||||
End point title |
Non relapse-Related Death | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
2 years
|
|||||||||
|
||||||||||
Statistical analysis title |
Non relapse-Related Death | |||||||||
Comparison groups |
Treatment with ATG v Non ATG
|
|||||||||
Number of subjects included in analysis |
155
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
superiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
|
||||||||||
End point title |
Chronic GVHD–free + Relapse free Survival | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
2 years
|
|||||||||
|
||||||||||
Statistical analysis title |
Chronic GVHD–free + Relapse free Survival | |||||||||
Comparison groups |
Treatment with ATG v Non ATG
|
|||||||||
Number of subjects included in analysis |
155
|
|||||||||
Analysis specification |
Post-hoc
|
|||||||||
Analysis type |
superiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
Regression, Cox | |||||||||
Confidence interval |
|
|||||||||||||
End point title |
Leucocytes engrafment | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
2 years
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Leucocytes engrafment analysis | ||||||||||||
Comparison groups |
Treatment with ATG v Non ATG
|
||||||||||||
Number of subjects included in analysis |
155
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Platelet engrafment | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
2 years
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Platelet engrafment analysis | ||||||||||||
Comparison groups |
Treatment with ATG v Non ATG
|
||||||||||||
Number of subjects included in analysis |
155
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|
||||||||||
End point title |
Acute GVHD | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
100 days
|
|||||||||
|
||||||||||
Statistical analysis title |
Acute GVHD analysis | |||||||||
Comparison groups |
Treatment with ATG v Non ATG
|
|||||||||
Number of subjects included in analysis |
155
|
|||||||||
Analysis specification |
Post-hoc
|
|||||||||
Analysis type |
superiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
Regression, Cox | |||||||||
Confidence interval |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Report period (any causal relationship to ATG-Fresenius S), by MedDRA System Organ Classes and Preferred Terms (all randomized patients).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
8.0
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment with ATG
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Randomized and allocated in experimental arm where patients have been treated adding ATG to the standard GVHD prophylaxis with CSA and MTX | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
NON-ATG
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Randomized, treated and allocated to comparator arm where patients received the standard GVHD prophylaxis with CSA and MTX | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 4.77% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |