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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 : Recruiting
First Posted : August 26, 2016
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Nicola Goekbuget, Goethe University

Tracking Information
First Submitted Date  ICMJE August 4, 2016
First Posted Date  ICMJE August 26, 2016
Last Update Posted Date June 28, 2019
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2016)
Event free survival [ Time Frame: 3.5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02881086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2016)
  • Time until consolidation treatment I [ Time Frame: approximately 70 days ]
  • Disease free survival [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 23, 2016)
  • Hematological remission rate [ Time Frame: after induction, approximately 6-8 weeks from diagnosis ]
  • Molecular remission rate [ Time Frame: after induction and consolidation, approximately 6-8 weeks from diagnosis ]
  • Results of the positron emission tomography (PET) based remission evaluation [ Time Frame: after consolidation, approximately 8-10 weeks ]
  • Remission duration [ Time Frame: up to 10 years ]
  • Relapse rate [ Time Frame: up to 10 years ]
  • Overall survival [ Time Frame: up to 10 years ]
  • Relapse location [ Time Frame: at timepoint of relapse (up to 10 years) ]
  • Early death [ Time Frame: during induction, approximately 6-8 weeks from diagnosis ]
  • Death in clinical remission (CR) [ Time Frame: during treatment, up to approximately 2.5 years from diagnosis ]
  • Comorbidities according to Charlson Score [ Time Frame: up to 2.5 years ]
  • Quality of life assessed by QLQ-C30 [ Time Frame: up to 2.5 years ]
  • Eastern Cooperative Oncology Group (ECOG) under therapy [ Time Frame: up to 2.5 years ]
  • Toxicity assessed by CTCAE v4.03 [ Time Frame: up to 2.5 years ]
  • Results of the Dementia Detection (DemTect) test [ Time Frame: up to 2.5 years ]
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
Condition  ICMJE
  • Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma
Intervention  ICMJE
  • Drug: Rituximab
  • Drug: Nelarabine
  • Drug: PEG-Asparaginase
  • Procedure: Cranial irradiation
  • Drug: Imatinib
  • Drug: Idarubicin
  • Drug: Dexamethasone
  • Drug: Cyclophosphamide
  • Drug: Fludarabine
  • Drug: Vincristine
  • Drug: Mercaptopurine
  • Drug: VP16
  • Drug: Daunorubicin (DNR)
  • Drug: Methotrexate
  • Procedure: Stem cell transplantation
  • Drug: Cytarabine
  • Drug: Vindesine
  • Drug: Adriamycin
  • Drug: Prednisolone
Study Arms  ICMJE
  • Stratification I - Standard Risk (SR)/ High Risk (HR)
    Induction and consolidation I therapy for standard and high risk patients, PH/BCR-ABL-negative Chemotherapy, immunotherapy, intrathecal prophylaxis, CNS irradiation according to randomisation I Drugs: Rituximab, Vincristine, Daunorubicin, Dexamethasone, Cyclophosphamide, Cytarabine, Mercaptopurine, PEG-Asparaginase, Methotrexate, Vindesine, VP16
    Interventions:
    • Drug: Rituximab
    • Drug: PEG-Asparaginase
    • Drug: Dexamethasone
    • Drug: Cyclophosphamide
    • Drug: Vincristine
    • Drug: Mercaptopurine
    • Drug: VP16
    • Drug: Daunorubicin (DNR)
    • Drug: Methotrexate
    • Drug: Cytarabine
    • Drug: Vindesine
  • Stratification I - Philadelphia (PH)+
    Induction and consolidation I therapy for PH+ patients Chemotherapy, immunotherapy, intrathecal prophylaxis Drugs: Rituximab, Vincristine, Imatinib, Dexamethasone, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, VP16
    Interventions:
    • Drug: Rituximab
    • Drug: PEG-Asparaginase
    • Drug: Imatinib
    • Drug: Dexamethasone
    • Drug: Vincristine
    • Drug: VP16
    • Drug: Methotrexate
    • Drug: Cytarabine
    • Drug: Vindesine
  • Active Comparator: Rand I - B-Lin + CNS Rad + i.th. MTX
    Chemotherapy according to Stratification I SR/HR CNS prophylaxis: CNS irradiation 24 Gy, intrathecal Methotrexate
    Interventions:
    • Procedure: Cranial irradiation
    • Drug: Methotrexate
  • Experimental: Rand I - B-Lin + i.th. MTX
    Chemotherapy according to Stratification I SR/HR CNS prophylaxis: intrathecal Methotrexate
    Intervention: Drug: Methotrexate
  • Stratification II - SR + MRD-neg
    Chemotherapy, immunotherapy, intrathecal prophylaxis, consolidation II, reinduction, consolidation III - VI, maintenance Drugs: Rituximab, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, Adriamycin, Prednisolone, Cyclophosphamide, Nelarabine, Dexamethasone
    Interventions:
    • Drug: Rituximab
    • Drug: Nelarabine
    • Drug: PEG-Asparaginase
    • Drug: Dexamethasone
    • Drug: Cyclophosphamide
    • Drug: Methotrexate
    • Drug: Cytarabine
    • Drug: Vindesine
    • Drug: Adriamycin
    • Drug: Prednisolone
  • Stratification II - HR + MRD-neg
    Chemotherapy or stem cell transplantation according to randomisation II
    Interventions:
    • Drug: Rituximab
    • Drug: Nelarabine
    • Drug: PEG-Asparaginase
    • Drug: Cyclophosphamide
    • Drug: Methotrexate
    • Procedure: Stem cell transplantation
    • Drug: Cytarabine
    • Drug: Vindesine
    • Drug: Adriamycin
    • Drug: Prednisolone
  • Stratification II - SR/HR/PH+ + MRD-pos
    Chemotherapy or targeted therapy, followed by stem cell transplantation Drugs: Fludarabine, Idarubicin, Cytarabine, Nelarabine
    Interventions:
    • Drug: Nelarabine
    • Drug: Idarubicin
    • Drug: Fludarabine
    • Drug: Cytarabine
  • Active Comparator: Randomisation II - HR + MRD-neg-SCT
    Stem cell transplantation
    Intervention: Procedure: Stem cell transplantation
  • Experimental: Randomisation II - HR + MRD-neg-SR-chemo
    Chemotherapy, immunotherapy, intrathecal prophylaxis, consolidation II, reinduction, consolidation III - VI, maintenance Drugs: Rituximab, Dexamethasone, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, Adriamycin, Prednisolone, Cyclophosphamide, Nelarabine
    Interventions:
    • Drug: Rituximab
    • Drug: Nelarabine
    • Drug: PEG-Asparaginase
    • Drug: Dexamethasone
    • Drug: Cyclophosphamide
    • Drug: Methotrexate
    • Drug: Cytarabine
    • Drug: Vindesine
    • Drug: Adriamycin
    • Drug: Prednisolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2016)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicola Gökbuget, Dr. med. +496963016365 goekbuget@em.uni-frankfurt.de
Contact: GMALL Study center +496963016366 gmall@em.uni-frankfurt.de
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
Plan to Share IPD: No
Responsible Party Nicola Goekbuget, Goethe University
Study Sponsor  ICMJE Goethe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicola Gökbuget, Dr. med. University Hospital of Frankfurt (Main)
PRS Account Goethe University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP