This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02881086
Recruitment Status : Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : July 18, 2023
Sponsor:
Information provided by (Responsible Party):
Nicola Goekbuget, Goethe University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma 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 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: 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
Actual Study Start Date : August 2016
Actual Primary Completion Date : August 2022
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 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
 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
 Procedure: Cranial irradiation
Drug: Methotrexate
Experimental: Rand I - B-Lin + i.th. MTX
Chemotherapy according to Stratification I SR/HR CNS prophylaxis: intrathecal Methotrexate
 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
 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
 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
 Drug: Nelarabine
Drug: Idarubicin
Drug: Fludarabine
Drug: Cytarabine
Active Comparator: Randomisation II - HR + MRD-neg-SCT
Stem cell transplantation
 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
 Drug: Rituximab
Drug: Nelarabine
Drug: PEG-Asparaginase
Drug: Dexamethasone
Drug: Cyclophosphamide
Drug: Methotrexate
Drug: Cytarabine
Drug: Vindesine
Drug: Adriamycin
Drug: Prednisolone


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Event free survival [ Time Frame: 3.5 years ]

Secondary Outcome Measures :
  1. Time until consolidation treatment I [ Time Frame: approximately 70 days ]
  2. Disease free survival [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Hematological remission rate [ Time Frame: after induction, approximately 6-8 weeks from diagnosis ]
  2. Molecular remission rate [ Time Frame: after induction and consolidation, approximately 6-8 weeks from diagnosis ]
  3. Results of the positron emission tomography (PET) based remission evaluation [ Time Frame: after consolidation, approximately 8-10 weeks ]
  4. Remission duration [ Time Frame: up to 10 years ]
  5. Relapse rate [ Time Frame: up to 10 years ]
  6. Overall survival [ Time Frame: up to 10 years ]
  7. Relapse location [ Time Frame: at timepoint of relapse (up to 10 years) ]
  8. Early death [ Time Frame: during induction, approximately 6-8 weeks from diagnosis ]
  9. Death in clinical remission (CR) [ Time Frame: during treatment, up to approximately 2.5 years from diagnosis ]
  10. Comorbidities according to Charlson Score [ Time Frame: up to 2.5 years ]
  11. Quality of life assessed by QLQ-C30 [ Time Frame: up to 2.5 years ]
  12. Eastern Cooperative Oncology Group (ECOG) under therapy [ Time Frame: up to 2.5 years ]
  13. Toxicity assessed by CTCAE v4.03 [ Time Frame: up to 2.5 years ]
  14. Results of the Dementia Detection (DemTect) test [ Time Frame: up to 2.5 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881086


Locations
Layout table for location information
Germany
University Hospital of Frankfurt (Main)
Frankfurt (Main), Germany, 60590
Sponsors and Collaborators
Goethe University
Investigators
Layout table for investigator information
Principal Investigator: Nicola Gökbuget, Dr. med. University Hospital of Frankfurt (Main)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nicola Goekbuget, GMALL Head, Goethe University
ClinicalTrials.gov Identifier: NCT02881086    
Other Study ID Numbers: GMALL08_2013
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: July 18, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nicola Goekbuget, Goethe University:
Acute lymphoblastic leukemia
Lymphoblastic lymphoma
Nelarabine
BCR-ABL
 MRD
PEG-Asparaginase
Rituximab
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Prednisolone
Cyclophosphamide
 Rituximab
Methotrexate
Fludarabine
Vincristine
Doxorubicin
Daunorubicin
Asparaginase
Mercaptopurine
Idarubicin
Pegaspargase
Vindesine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents