If for years the treatment strategy of leukemia and related disorders (LRDs, including acute leukemias and predisposition syndromes) has been based solely on whether the patient could receive or not intensive chemotherapy and transplantation, the advent of new targeted or less targeted drugs has led to the development of a growing number of new therapeutic approaches, very often offered to specific patient/disease subsets, justifying the generic term of 'precision medicine'. As an international leukemia center of excellence, THEMA, the French National Center for Precision Medicine in Leukemia (selected as IHUB-2 by the French National Agency for Research), is a care, research, transfer and education initiative located at the Saint-Louis Research Institute (IRSL) in Paris and devoted to precision medicine in leukemia in a real-life environment. The present non-interventional study (eTHEMA) is a pillar of the whole THEMA project. As a prerequisite for precision medicine, this program focuses on individual data collection, aiming to collect high-quality data not only in patients treated into prospective clinical trials, but in every THEMA patient with a special interest in outpatients' care and research. The primary objective of this non-interventional study is to describe the baseline characteristics planned treatments and outcomes of patients newly diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or myeloproliferative neoplasm (MPN)-related myelofibrosis, when managed and treated according to standard diagnosis and care practices.
Study Type
OBSERVATIONAL
Enrollment
3,000
For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored.
Hôpital Avicenne
Bobigny, France
RECRUITINGHopital Robert Debré
Paris, France
RECRUITINGHôpital Saint Louis
Paris, France
RECRUITINGEvent Free Survival
Time frame: at 5 years
Relapse Free Survival
Time frame: at 5 years
Overall Survival
Time frame: at 5 years
Standardized evaluation of hematological response
Time frame: After induction cycle which is between between day 25 and day 42 for patients treated intensively and between Month 1 and Month 6 for patients treated treated with low intensity regimen
Standardized evaluation of hematological response
Time frame: After first consolidation cycle which is between 1 and 2 months
Standardized evaluation of hematological response
Time frame: After last consolidation cycle which is between 3 and 8 months
Standardized evaluation of hematological response
Time frame: Before HSCT
Standardized evaluation of hematological response
Time frame: at day 100 after HSCT
Standardized evaluation of hematological response
Time frame: at 5 years
Minimal measurable residual disease (MRD) response
Time frame: After induction which is between day 25 and day 42 for patients treated intensively and between month 1 and month 6 for patients with low intensity regimen
Minimal measurable residual disease (MRD) response
Time frame: After first consolidation cycle which is between 1 and 2 months
Minimal measurable residual disease (MRD) response
Time frame: After last consolidation cycle which is between 3 and 8 months
Minimal measurable residual disease (MRD) response
Time frame: Before HSCT
Minimal measurable residual disease (MRD) response
Time frame: at day 100 after HSCT
Minimal measurable residual disease (MRD) response
Time frame: at 5 years
Incidence of allogeneic HSCT
Time frame: at 5 years
Modalities of allogeneic HSCT
Time frame: at 5 years
Incidence of hematological relapses
Time frame: at 5 years
Type of hematological relapses
Time frame: at 5 years
Incidence of hematological progressions
Time frame: at 5 years
Type of hematological progressions
Time frame: at 5 years
Incidence of MRD relapses
Time frame: at 5 years
Incidence of MRD progressions
Time frame: at 5 years
Proportions of patients with treatment-related toxicities
Treatment-related toxicities will be Evaluated by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: at 5 years
Cumulative incidences of relapse
Time frame: at 5 years
Cumulative incidences of non-relapse mortality
Time frame: at 5 years
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Time frame: at inclusion
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire.Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Time frame: at the end of induction which is between day 25 and day 42 for patients treated intensively and between month 1 and month 6 for patients with low intensity regimen
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire. Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Time frame: after 2 consolidations courses which is between 3 months and 8 months
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire. Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Time frame: at 3 months after the end of treatment
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire. Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Time frame: at 6 months after the end of treatment
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire. Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Time frame: at 12 months after the end of treatment
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire. Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Time frame: at day 100 after hematopoietic stem cell transplant
Incidence of secondary cancer
Time frame: at 5 years
Incidence of secondary cancer
Time frame: up to 15 years
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