Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Overall Survival |
|
at one year |
|
Secondary |
Graft failure incidence |
|
at 3 months |
|
Secondary |
Neutrophils engraftment |
3 consecutive days with neutrophiles >0.5 G/L |
at day 100 |
|
Secondary |
Platelets engraftment |
7 consecutive days with platelets >20 G/L |
at day 100 |
|
Secondary |
Absolute numbers of neutrophils |
|
at 1 month |
|
Secondary |
Absolute numbers of neutrophils |
|
at 2 months |
|
Secondary |
Absolute numbers of neutrophils |
|
at 3 months |
|
Secondary |
Absolute numbers of neutrophils |
|
at 6 months |
|
Secondary |
Absolute numbers of neutrophils |
|
at 12 months |
|
Secondary |
Absolute numbers of neutrophils |
|
through study completion, an average of 6 months |
|
Secondary |
Absolute number of platelets |
|
at one month |
|
Secondary |
Absolute number of platelets |
|
at 2 months |
|
Secondary |
Absolute number of platelets |
|
at 3 months |
|
Secondary |
Absolute number of platelets |
|
at 6 months |
|
Secondary |
Absolute number of platelets |
|
at 12 months |
|
Secondary |
Absolute number of platelets |
|
through study completion, an average of 6 months |
|
Secondary |
Incidence of use of growth factors for poor hematopoietic reconstitution |
|
at 3 months |
|
Secondary |
Acute GvHD incidence |
|
at 3 months |
|
Secondary |
Chronic GvHD incidence |
|
at 24 months |
|
Secondary |
Relapse incidence |
|
at 12 months |
|
Secondary |
Relapse incidence |
|
at 24 months |
|
Secondary |
Progression free survival |
|
at 12 months |
|
Secondary |
Progression free survival |
|
at 24 months |
|
Secondary |
Incidence of CMV infection |
|
at 12 months |
|
Secondary |
Incidence of EBV infection |
|
at 12 months |
|
Secondary |
Incidence of severe infections |
Severe infections are defined as CTAE grade of 3 or 4 |
at 3 months |
|
Secondary |
Incidence of severe infections |
Severe infections are defined as CTAE grade of 3 or 4 |
at 6 months |
|
Secondary |
Incidence of severe infections |
Severe infections are defined as CTAE grade of 3 or 4 |
at 12 months |
|
Secondary |
Incidence of severe infections |
Severe infections are defined as CTAE grade of 3 or 4 |
at 24 months |
|
Secondary |
Incidence of veino-occlusive disease (VOD) |
|
at 3 months |
|
Secondary |
Severity of veino-occlusive disease (VOD) |
|
at 3 months |
|
Secondary |
Non-relapse mortality |
|
at 24 months |
|
Secondary |
Incidence of cardiac toxicities |
|
at 12 months |
|
Secondary |
Overall survival |
|
at 24 months |
|
Secondary |
Interval between first allo-SCT and rescue haplo-SCT |
|
at 60 days |
|
Secondary |
Quality of life for adults |
Quality of life will be assessed for adults using "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" EORTC QLQ-C30-V3 questionnaire.The QLQ-C30 is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
at 3 months |
|
Secondary |
Quality of life for adults |
Quality of life will be assessed for adults using "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" EORTC QLQ-C30-V3 questionnaire.The QLQ-C30 is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
at 6 months |
|
Secondary |
Quality of life for adults |
Quality of life will be assessed for adults using "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" EORTC QLQ-C30-V3 questionnaire.The QLQ-C30 is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
at 12 months |
|
Secondary |
Quality of life for adults |
Quality of life will be assessed for adults using "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" EORTC QLQ-C30-V3 questionnaire.The QLQ-C30 is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
at 24 months |
|
Secondary |
Quality of life for minors |
Quality of life will be assessed for minor using The Pediatric Quality of Life Inventory™ (PedsQL™) The 36-item PedsQL™ Family Impact Module is a parent-report instrument designed to assess the impact of pediatric chronic health conditions on parents and the family. It includes 6 subscales measuring parents' self-reported functioning. The scale has five Likert response options, 'never', 'almost never', 'sometimes', 'often' and 'almost always' (corresponding to scores of 100, 75, 50, 25 and 0). Higher scores indicate better functioning |
at 3 months |
|
Secondary |
Quality of life for minors |
Quality of life will be assessed for minor using The Pediatric Quality of Life Inventory™ (PedsQL™) The 36-item PedsQL™ Family Impact Module is a parent-report instrument designed to assess the impact of pediatric chronic health conditions on parents and the family. It includes 6 subscales measuring parents' self-reported functioning. The scale has five Likert response options, 'never', 'almost never', 'sometimes', 'often' and 'almost always' (corresponding to scores of 100, 75, 50, 25 and 0). Higher scores indicate better functioning |
at 6 months |
|
Secondary |
Quality of life for minors |
Quality of life will be assessed for minor using The Pediatric Quality of Life Inventory™ (PedsQL™) The 36-item PedsQL™ Family Impact Module is a parent-report instrument designed to assess the impact of pediatric chronic health conditions on parents and the family. It includes 6 subscales measuring parents' self-reported functioning. The scale has five Likert response options, 'never', 'almost never', 'sometimes', 'often' and 'almost always' (corresponding to scores of 100, 75, 50, 25 and 0). Higher scores indicate better functioning |
at 12 months |
|
Secondary |
Quality of life for minors |
Quality of life will be assessed for minor using The Pediatric Quality of Life Inventory™ (PedsQL™) The 36-item PedsQL™ Family Impact Module is a parent-report instrument designed to assess the impact of pediatric chronic health conditions on parents and the family. It includes 6 subscales measuring parents' self-reported functioning. The scale has five Likert response options, 'never', 'almost never', 'sometimes', 'often' and 'almost always' (corresponding to scores of 100, 75, 50, 25 and 0). Higher scores indicate better functioning |
at 24 months |
|
Secondary |
Proportion of patients with a donor chimerism of 90% or more |
|
at 1 month |
|
Secondary |
Proportion of patients with a donor chimerism of 90% or more |
|
at 3 months |
|
Secondary |
Proportion of patients with a donor chimerism of 90% or more |
|
at 6 months |
|
Secondary |
Proportion of patients with a donor chimerism of 90% or more |
|
at 12 months |
|
Secondary |
Immune reconstitution |
Immune reconstitution will be defined by analyzing T, B, NK, regulatory T cell levels in the peripheral blood |
at 3 months post-transplantation |
|
Secondary |
Immune reconstitution |
Immune reconstitution will be defined by analyzing T, B, NK, regulatory T cell levels in the peripheral blood |
at 6 months post-transplantation |
|
Secondary |
Immune reconstitution |
Immune reconstitution will be defined by analyzing T, B, NK, regulatory T cell levels in the peripheral blood |
at 12 months post-transplantation |
|
Secondary |
Immune reconstitution |
Immune reconstitution will be defined by analyzing T, B, NK, regulatory T cell levels in the peripheral blood |
at 24 months post-transplantation |
|
Secondary |
Iron overload estimation |
|
at 3 months |
|
Secondary |
Iron overload estimation |
|
at 6 months |
|
Secondary |
Iron overload estimation |
|
at 12 months |
|
Secondary |
Iron overload estimation |
|
at 24 months |
|