De-escalated Treatment Approach for Adult Ph-negative Acute Lymphoblastic Leukemia (ALL)
NCT ID: NCT03462095
Last Updated: 2018-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
350 participants
INTERVENTIONAL
2017-01-31
2022-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
NCT06237192
Multicenter Clinical Trial for Adult Ph-negative ALL. Non-intensive But Non-iterruptive Treatment
NCT01193933
Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients
NCT02042690
Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia (ALL)
NCT00131053
Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
NCT07059156
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses,
1. instead of 2 Cph injections during induction,
2. instead of 4 ARA-C blocks, distribution of of L-asp injections through all phases
* After CR achievement T-cell ALL patients are being randomized to auto-HSCT vs no auto-HSCT
* Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted
* After the 3rd consolidation stem cells harvesting is carried out for T-cell ALL patients randomized to auto-HSCT
* Auto-HSCT after the 5th consolidation phase with non-myeloablative CEAM conditioning
* 2 years maintenance for all patients
* 21 TIT through the whole treatment with higher intensity during induction\|consolidation
* Centralized MRD monitoring at +70 d, + 133 d, + 190 days; before and after auto-HSCT
* Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity at day +190)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
no Auto-HSCT
After completing prolonged consolidation T-cell ALL patients will continue with 2 years maintenance
No interventions assigned to this group
Auto-HSCT
After completing prolonged consolidation T-cell ALL patients will get autologous HSCT followed by 2 years maintenance
Autologous HSCT
After the 3rd consolidation, T-cell ALL patients, randomized to auto-HSCT will be mobilised by G-SCF and harvested disregarding MRD-status. After completing the 5th consolidation T-ALL patients will be transplanted after non-myeloablative CEAM (CCNU, Ethoposide, ARA-C, Melphalan) conditioning, and after reconstitution will continue 2-years maintenance
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Autologous HSCT
After the 3rd consolidation, T-cell ALL patients, randomized to auto-HSCT will be mobilised by G-SCF and harvested disregarding MRD-status. After completing the 5th consolidation T-ALL patients will be transplanted after non-myeloablative CEAM (CCNU, Ethoposide, ARA-C, Melphalan) conditioning, and after reconstitution will continue 2-years maintenance
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Research Center for Hematology, Russia
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Valeriy V Savchenko, Academician
Role: STUDY_DIRECTOR
National Research Center for hematology, Moscow, Russia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Research Center for Hematology
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ALL--2016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.