Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777916
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2021-02-25
Brief Title:
Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia AML
Sponsor:
Acute Leukemia French Association
Organization:
Acute Leukemia French Association
Study Overview
Official Title:
A Prospective Non-interventional Study Documenting the Management and Outcomes of Adult Patients With Acute Myeloid Leukemia AML
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALFAPPP
Brief Summary:
During the last fifteen years the landscape of AML diagnosis and therapeutical options has markedly evolved Refined genetic and prognostic characterizations together with new drug approvals and new allogeneic hematopoietic stem cell transplantation HSCT procedures have increased patient journey diversity
Detailed Description:
During the last fifteen years the landscape of AML diagnosis and therapeutical options has markedly evolved Refined genetic and prognostic characterizations together with new drug approvals and new allogeneic hematopoietic stem cell transplantation HSCT procedures have increased patient journey diversity
I - At initial AML diagnosis not all newly diagnosed patients are entering clinical trials A substantial proportion of them are treated with standard therapies outside of any trial To date the standard approved frontline treatment options include
1 Standard intensive 37 anthracycline cytarabine chemotherapy an approved FLT3 inhibitor midostaurine Rydapt according to different dose schedules in older versus younger patients
2 Combination of sequential gemtuzumab ozogamicin GO Mylotarg with 37
3 Liposomal formulation of daunorubicin cytarabine CPX-351 Vyxeos
4 Less intensive chemotherapy with azacytidine or low dose cytarabine LDAC in patients considered as not eligible for the more intensive options above
The investigators choice is guided by AML and patients characteristics and by the approved indications for each of these treatment options This study will thus start including these specific options Further study amendments might be necessary in case of new standard treatment definition
II - Secondly no specific salvage regimen has emerged as a standard in patients with primary refractory or relapsed AML RR AML RR AML is thus an important field for investigational new drugs INDs and precision medicine development To date the only IND approved to treat RR AML is gilteritinib for FLT3-mutated AML patients The French agency ANSM also allow to use GO for treating RR AML patients in the frame of a RTU Recommendation Temporaire dUtilisation
In the real life because of the multiplicity of treatments used in these patients some of them being now quite efficient it has become difficult to accurately describe the general outcome of RR AML patients
III - Thirdly allogeneic HSCT is no more considered at the ultimate and final goal of AML therapy in all patients as it was in the past Transplant indications have been better described and HSCT in now evaluated in the context of the whole treatment course including pre- and post-transplant therapy as well as pre- and post-transplant minimal residual disease MRD levels
For all these reasons it is of utmost importance to document the various characteristics treatments and outcomes of patients treated in the real-life outside of clinical trials for 1 real-world treatment evaluation 2 post-approval use of recently approved drugs 3 standardization and improvement of routine patient management and 4 better disease understanding
I - At initial AML diagnosis not all newly diagnosed patients are entering clinical trials A substantial proportion of them are treated with standard therapies outside of any trial To date the standard approved frontline treatment options include
1 Standard intensive 37 anthracycline cytarabine chemotherapy an approved FLT3 inhibitor midostaurine Rydapt according to different dose schedules in older versus younger patients
2 Combination of sequential gemtuzumab ozogamicin GO Mylotarg with 37
3 Liposomal formulation of daunorubicin cytarabine CPX-351 Vyxeos
4 Less intensive chemotherapy with azacytidine or low dose cytarabine LDAC in patients considered as not eligible for the more intensive options above
The investigators choice is guided by AML and patients characteristics and by the approved indications for each of these treatment options This study will thus start including these specific options Further study amendments might be necessary in case of new standard treatment definition
II - Secondly no specific salvage regimen has emerged as a standard in patients with primary refractory or relapsed AML RR AML RR AML is thus an important field for investigational new drugs INDs and precision medicine development To date the only IND approved to treat RR AML is gilteritinib for FLT3-mutated AML patients The French agency ANSM also allow to use GO for treating RR AML patients in the frame of a RTU Recommendation Temporaire dUtilisation
In the real life because of the multiplicity of treatments used in these patients some of them being now quite efficient it has become difficult to accurately describe the general outcome of RR AML patients
III - Thirdly allogeneic HSCT is no more considered at the ultimate and final goal of AML therapy in all patients as it was in the past Transplant indications have been better described and HSCT in now evaluated in the context of the whole treatment course including pre- and post-transplant therapy as well as pre- and post-transplant minimal residual disease MRD levels
For all these reasons it is of utmost importance to document the various characteristics treatments and outcomes of patients treated in the real-life outside of clinical trials for 1 real-world treatment evaluation 2 post-approval use of recently approved drugs 3 standardization and improvement of routine patient management and 4 better disease understanding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None