Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Overall Survival Rate |
|
2 years after transplant |
|
Secondary |
Engraftment |
Engraftment at least 3 consecutive days with neutrophils > 0.5 G/L and 7 consecutive days with platelets > 20 G/L, with predominantly whole blood donor chimerism |
At day 100 |
|
Secondary |
Absolute neutrophils count |
|
At 1 month |
|
Secondary |
Absolute neutrophils count |
|
At 3 months |
|
Secondary |
Absolute neutrophils count |
|
At 6 months |
|
Secondary |
Absolute neutrophils count |
|
At 12 months |
|
Secondary |
Absolute neutrophils count |
|
At 24 months |
|
Secondary |
Absolute number of platelets |
|
At 1 month |
|
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 |
|
At 24 months |
|
Secondary |
Incidence of grade 2 to 4 Acute Graft versus Host Disease |
|
At 3 months |
|
Secondary |
Incidence of Acute cortico-resistant Graft versus Host Disease |
|
At 3 months |
|
Secondary |
Incidence of Chronic Graft versus Host Disease |
|
At 24 months |
|
Secondary |
Incidence of relapse |
|
At 12 months |
|
Secondary |
Incidence of relapse |
|
At 24 months |
|
Secondary |
Progression free survival |
|
At 12 months |
|
Secondary |
Progression free survival |
|
At 24 months |
|
Secondary |
Incidence of reactivation of cytomegalovirus infection |
|
At 12 months |
|
Secondary |
Incidence of reactivation of Epstein Barr virus infection |
|
At 12 months |
|
Secondary |
Incidence of severe infection of grade 4 and above according to Common Terminology Criteria for Adverse Events (CTCAE) |
|
At 3 months |
|
Secondary |
Incidence of severe infection of grade 4 and above according to Common Terminology Criteria for Adverse Events (CTCAE) |
|
At 6 months |
|
Secondary |
Incidence of severe infection of grade 4 and above according to Common Terminology Criteria for Adverse Events (CTCAE) |
|
At 12 months |
|
Secondary |
Incidence of severe infection of grade 4 and above according to Common Terminology Criteria for Adverse Events (CTCAE) |
|
At 24 months |
|
Secondary |
Graft-versus-host disease-free, relapse-free survival (GRFS) |
|
At 24 months |
|
Secondary |
Incidence of cardiac toxities |
|
At 12 months |
|
Secondary |
Overall survival |
|
At 12 months |
|
Secondary |
Quality of Life questionnaire for adults |
Quality of life will be assessed for adult using "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) " 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 inclusion |
|
Secondary |
Quality of Life questionnaire for adults |
Quality of life will be assessed for adult using "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) " 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 questionnaire for adults |
Quality of life will be assessed for adult using "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) " 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 questionnaire for adults |
Quality of life will be assessed for adult using "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) " 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 questionnaire for adults |
Quality of life will be assessed for adult using "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) " 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 questionnaire 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 inclusion |
|
Secondary |
Quality of life questionnaire 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 questionnaire 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 questionnaire 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 questionnaire 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 |
Rate of chimerism |
|
At 1 month |
|
Secondary |
Rate of chimerism |
|
At 3 months |
|
Secondary |
Rate of chimerism |
|
At 6 months |
|
Secondary |
Rate of chimerism |
|
At 12 months |
|
Secondary |
Rate of chimerism |
|
At 24 months |
|
Secondary |
Immune reconstitution by analyzing T, B, natural killer (NK), regulatory T cell levels in the peripheral blood |
|
3 months after transplant |
|
Secondary |
Immune reconstitution by analyzing T, B, natural killer (NK), regulatory T cell levels in the peripheral blood |
|
6 months after transplant |
|
Secondary |
Immune reconstitution by analyzing T, B, natural killer (NK), regulatory T cell levels in the peripheral blood |
|
12 months after transplant |
|
Secondary |
Immune reconstitution by analyzing T, B, natural killer (NK), regulatory T cell levels in the peripheral blood |
|
24 months after transplant |
|
Secondary |
Ferritine levels |
|
At 3 months |
|
Secondary |
Ferritine levels |
|
At 6 months |
|
Secondary |
Ferritine levels |
|
At 12 months |
|
Secondary |
Ferritine levels |
|
At 24 months |
|