Clinical trial NCT02881086: Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Keywords: Acute lymphoblastic leukemia
Lymphoblastic lymphoma
Nelarabine
BCR-ABL
MRD
PEG-Asparaginase
Rituximab
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Event free survival
timeFrame: 3.5 years
Secondary outcomes:
measure: Time until consolidation treatment I
timeFrame: approximately 70 days
measure: Disease free survival
timeFrame: 1 year
Other outcomes:
measure: Hematological remission rate
timeFrame: after induction, approximately 6-8 weeks from diagnosis
measure: Molecular remission rate
timeFrame: after induction and consolidation, approximately 6-8 weeks from diagnosis
measure: Results of the positron emission tomography (PET) based remission evaluation
timeFrame: after consolidation, approximately 8-10 weeks
measure: Remission duration
timeFrame: up to 10 years
measure: Relapse rate
timeFrame: up to 10 years
measure: Overall survival
timeFrame: up to 10 years
measure: Relapse location
timeFrame: at timepoint of relapse (up to 10 years)
measure: Early death
timeFrame: during induction, approximately 6-8 weeks from diagnosis
measure: Death in clinical remission (CR)
timeFrame: during treatment, up to approximately 2.5 years from diagnosis
measure: Comorbidities according to Charlson Score
timeFrame: up to 2.5 years
measure: Quality of life assessed by QLQ-C30
timeFrame: up to 2.5 years
measure: Eastern Cooperative Oncology Group (ECOG) under therapy
timeFrame: up to 2.5 years
measure: Toxicity assessed by CTCAE v4.03
timeFrame: up to 2.5 years
measure: Results of the Dementia Detection (DemTect) test
timeFrame: up to 2.5 years
Locations:
city: Frankfurt (Main)
country: Germany
facility: University Hospital of Frankfurt (Main)
Study officials:
affiliation: University Hospital of Frankfurt (Main)
name: Nicola Gökbuget, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: