Newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma Age 18 to 55 y MedDRA version: 21.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10065923 Term: Lymphoblastic lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Atriance
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: NELARABINE
CAS Number: 121032-29-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Goethe University Frankfurt
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Acute lymphoblastic leukemia (all subtypes except burkitt leukemia, blasts in BM = 25% or • Lymphoblastic lymphoma (B- or T-lineage), blasts in BM =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Serious complications (leukemia associated) or concomitant diseases, such as - severe uncontrollable complications (leukemia associated), i.e. sepsis, pneumonia with hypoxia, shock, bleeding at diagnosis - renal insufficiency, if not caused by leukemia - severe impairment of heart or liver function (if not caused by leukemic infiltration) - severe obstructive or restrictive pulmonary disease - known HIV infection or other uncontrolled infections - any other condition that compromises the patient’s eligibility for intensive treatment as described by the study protocol • Late relapse of childhood leukemia or concurrent malignancy • Previous cytostatic treatment - ALL directed (exceptions: standard prephase, application of steroids = 7 days, once-only application of vincristine, cyclophosphamide or other substances as emergency medical intervention) - directed to other malignancies within the last 10 years before diagnosis of ALL • Pregnancy or breastfeeding • Severe psychiatric disease or any severe concomitant condition under which the patient's understanding of importance and consequences of study participation and/or compliance and therapy according to study protocol cannot be expected • At diagnosis: participation in another trial that interferes with the antileukemic treatment (exceptions: trials aiming at supportive care, defined accompanying GMALL trials, and at a later timepoint trials with experimental substances, i. e. in case of molecular treatment failure)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To improve event free survival (EFS), remission duration (RD), disease free survival (DFS) and overall survival (OS) compared with the previous trial GMALL 07/2003 ;Secondary Objective: 1. To evaluate the role of CNS radiation and the role of chemotherapy alone in high risk ALL in molecular remission by randomised evaluation R1: CNS rad + i.th. vs i.th.alone R2: SCT vs chemotherapy in pts with molCR 2. To evaluate the feasibility of the entire treatment concept (i.e. adherence to schedule, administration of single and combination chemotherapy, maintenance therapy) 3. To evaluate feasibility and tolerability of nelarabine (IMP) as part of consolidation treatment in T-ALL 4. To perform prospective and concomitant monitoring of comorbidities and specifically defined serious adverse events 5. To evaluate an innovative overall approach to optimize treatment of a rare, biologically diverse disease by use of subgroup specific targeted and experimental substances within the main trial and in associated studies 6. To set up an interlinked biomaterial bank to prospectively evaluate molecular genetic risk factors and carry out scientific accompanying projects ;Primary end point(s): Event free survival compared with GMALL 07/2003;Timepoint(s) of evaluation of this end point: at 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. time (days) until start of consolidation cycle I (for randomisation I) 2. disease free survival (for randomisation II);Timepoint(s) of evaluation of this end point: 1. Start date of consolidation cycle I 2. at 3,5 years | — |
Countries
Germany
Contacts
Public ContactGMALL Studienzentrale
University Hospital Frankfurt
Outcome results
None listed