Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment
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ClinicalTrials.gov Identifier: NCT02881086 |
Recruitment Status :
Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : May 6, 2024
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Sponsor:
Goethe University
Information provided by (Responsible Party):
Nicola Goekbuget, Goethe University
Tracking Information | ||||
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First Submitted Date ICMJE | August 4, 2016 | |||
First Posted Date ICMJE | August 26, 2016 | |||
Last Update Posted Date | May 6, 2024 | |||
Actual Study Start Date ICMJE | August 2016 | |||
Actual Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Event free survival [ Time Frame: 3.5 years ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | |||
Descriptive Information | ||||
Brief Title ICMJE | Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment | |||
Official Title ICMJE | Treatment Optimization in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment - a Phase IV-trial With a Phase III-part to Evaluate Safety and Efficacy of Nelarabine in T-ALL Patients | |||
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 Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
1000 | |||
Original Estimated Enrollment ICMJE |
900 | |||
Estimated Study Completion Date ICMJE | July 2025 | |||
Actual Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02881086 | |||
Other Study ID Numbers ICMJE | GMALL08_2013 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Nicola Goekbuget, Goethe University | |||
Original Responsible Party | Nicola Goekbuget, Goethe University, Dr. med, MD | |||
Current Study Sponsor ICMJE | Goethe University | |||
Original Study Sponsor ICMJE | Johann Wolfgang Goethe University Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Goethe University | |||
Verification Date | May 2024 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |