Clinical trial · Observational
Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients
A Retrospective Analysis of Hematological Relapse Free Survival and Overall Survival in Adult Patients With Philadelphia-Negative B-Precursor Acute Lymphoblastic Leukemia in Complete Hematological Remission With Minimal Residual Disease
NCT02010931CI-TRIAL-00060880completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A retrospective analysis of historical data looking at relapse free survival and overall survival rates in adult philadelphia negative B-pre-cursor acute lymphoblastic leukemia patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- primary
- description
- subjects who are 18 years or older, who have minimal residual disease detected by PCR at a level of 1/10-3 or higher, who are free form allogeneic stem cell transplantation until hematological relapse or until 18 months after minimal residual disease detection (whichever comes first)
Primary outcomes (1)
- measure
- hematological relapse free survival
- timeFrame
- Approximately 18 months
- description
- to estimate the hematological relapse free survival in patients who are 18 years or older, who have minimal residual disease detected by PCR at a level of 1/10-3 or higher, who are free form allogeneic stem cell transplantation until hematological relapse or until 18 months after minimal residual disease detection (whichever comes first)
Secondary outcomes (3)
- measure
- hematological relapse free survival
- timeFrame
- Approximately 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * patients with Philadelphia-negative B-Precursor Acute Lyphmoblastic Leukemia in complete hematological remission defined as less than 5% blasts in bone marrow after at least 3 intensive chemotherapy blocks (i.e. any standard or investigational regimen according to adult protocols as long as 3 age appropriate chemotherapy blocks were given, this also includes relapse treatment * detection of minimal residual disease (molecular failure or molecular relapse) at a level of greater than or equal to 10\*(-4) by PCR or greater than or equal to 10\*(-3) by flow cytometry at a reference lab * Age 15 or greater at time of initial diagnosis with acute lymphoblastic leukemia. For patients aged 15-17 treatment according to adult protocols is required * Initial diagnosis in the year 2000 or later * History of acute lymphoblastic leukemia treatment (including response to first therapy, number of prior relapses) is available * Relapse status and disease follow up after timepoint of minimal residual disease detection is available Exclusion Criteria: * Patients with extramedullary disease at timepoint of minimal residual disease detection * Use of Blinatumomab within 18 months of minimal residual disease detection * Allogeneic hematopoietic stem cell transplantation prior to minimal residual disease detection at the required level
References
Publications (1)
- BACKGROUNDGokbuget N, Dombret H, Giebel S, Bruggemann M, Doubek M, Foa R, Hoelzer D, Kim C, Martinelli G, Parovichnikova E, Maria Ribera J, Schoonen M, Tuglus C, Zugmaier G, Bassan R. Blinatumomab vs historic standard-of-care treatment for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukaemia. Eur J Haematol. 2020 Apr;104(4):299-309. doi: 10.1111/ejh.13375. Epub 2020 Jan 24. PMID 31876009