Clinical Trial: Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Treatment Optimization in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Trea
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.
Detailed Summary:
Sponsor: Johann Wolfgang Goethe University Hospital
Current Primary Outcome: Event free survival [ Time Frame: 3.5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time until consolidation treatment I [ Time Frame: approximately 70 days ]
- Disease free survival [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Johann Wolfgang Goethe University Hospital
Dates:
Date Received: August 4, 2016
Date Started: August 2016
Date Completion: June 2025
Last Updated: August 23, 2016
Last Verified: August 2016
