Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Goethe University; Johann Wolfgang Goethe University Hospital
• Treatments: 6-Mercaptopurine; Asparaginase; BB 1101; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Etoposide; Fludarabine; Fludarabine phosphate; Idarubicin; Imatinib Mesylate; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Pegaspargase; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab; Vincristine; Vindesine

Criteria

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