Clinical Trial: NCT02881086
Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Goethe University |
| Information Provided By: | Goethe University |
| Last Update Posted: | 2025-12-16 |
Study Overview
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.
Official Title
Conditions
Intervention / Treatment
- Drug: Rituximab
- Drug: Nelarabine
- Drug: PEG-Asparaginase
- Procedure: Cranial irradiation
- Drug: Imatinib
- Drug: Idarubicin
- Drug: Dexamethasone
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Vincristine
- Drug: Mercaptopurine
- Drug: VP16
- Drug: Daunorubicin (DNR)
- Drug: Methotrexate
- Procedure: Stem cell transplantation
- Drug: Cytarabine
- Drug: Vindesine
- Drug: Adriamycin
- Drug: Prednisolone
Other Study ID Numbers
- GMALL08_2013
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Goethe University |
| Information Provided By: | Goethe University |
| Last Update Posted: | 2025-12-16 |
Study Overview
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.
Official Title
Conditions
Intervention / Treatment
- Drug: Rituximab
- Drug: Nelarabine
- Drug: PEG-Asparaginase
- Procedure: Cranial irradiation
- Drug: Imatinib
- Drug: Idarubicin
- Drug: Dexamethasone
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Vincristine
- Drug: Mercaptopurine
- Drug: VP16
- Drug: Daunorubicin (DNR)
- Drug: Methotrexate
- Procedure: Stem cell transplantation
- Drug: Cytarabine
- Drug: Vindesine
- Drug: Adriamycin
- Drug: Prednisolone
Other Study ID Numbers
- GMALL08_2013