Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
Conditions
Keywords
Acute lymphoblastic leukemia, Lymphoblastic lymphoma, Nelarabine, BCR-ABL, MRD, PEG-Asparaginase, Rituximab
Brief summary
A phase IV study with the primary goal to optimize therapy of adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma (LBL) by dose and time intensive, pediatric based chemotherapy, risk adapted stem cell transplantation (SCT) and minimal residual disease (MRD) based individualised and intensified therapy. Study will further evaluate the role of asparaginase intensification, the extended use of rituximab and the use of nelarabine as consolidation therapy in T-ALL in a phase III-part of the study. Furthermore two randomisations will focus on the role of central nervous system (CNS) irradiation in combination with intrathecal therapy versus intrathecal therapy only in B-precursor ALL/LBL and the role of SCT in high-risk patients with molecular complete remission. Finally a new, dose reduced induction therapy in combination with Imatinib will be evaluated in Ph/BCR-ABL positive ALL.
Interventions
DRUGPrednisolone
DRUGRituximab
DRUGNelarabine
DRUGPEG-Asparaginase
PROCEDURECranial irradiation
DRUGImatinib
DRUGIdarubicin
DRUGDexamethasone
DRUGCyclophosphamide
DRUGFludarabine
DRUGVincristine
DRUGMercaptopurine
DRUGVP16
DRUGDaunorubicin (DNR)
DRUGMethotrexate
PROCEDUREStem cell transplantation
DRUGCytarabine
DRUGVindesine
DRUGAdriamycin
Sponsors
Goethe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T) * Lymphoblastic lymphoma (B or T-lineage) * Age 18-55 yrs * Written informed consent * Adequate contraception as specified per protocol
Exclusion criteria
* Severe comorbidity or leukemia associated complications * Late relapse of pediatric ALL or ALL as second malignancy * Cytostatic pre-treatment * Pregnancy or breast feeding * Severe psychiatric illness or other circumstances which may compromise cooperation of the patient * Participation in other clinical trials interfering with the study therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival | 3.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Time until consolidation treatment I | approximately 70 days |
| Disease free survival | 1 year |
Other
| Measure | Time frame |
|---|---|
| Remission duration | up to 10 years |
| Relapse rate | up to 10 years |
| Overall survival | up to 10 years |
| Relapse location | at timepoint of relapse (up to 10 years) |
| Early death | during induction, approximately 6-8 weeks from diagnosis |
| Hematological remission rate | after induction, approximately 6-8 weeks from diagnosis |
| Comorbidities according to Charlson Score | up to 2.5 years |
| Quality of life assessed by QLQ-C30 | up to 2.5 years |
| Eastern Cooperative Oncology Group (ECOG) under therapy | up to 2.5 years |
| Toxicity assessed by CTCAE v4.03 | up to 2.5 years |
| Results of the Dementia Detection (DemTect) test | up to 2.5 years |
| Death in clinical remission (CR) | during treatment, up to approximately 2.5 years from diagnosis |
| Molecular remission rate | after induction and consolidation, approximately 6-8 weeks from diagnosis |
| Results of the positron emission tomography (PET) based remission evaluation | after consolidation, approximately 8-10 weeks |
Countries
Germany
Outcome results
None listed