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Trial record 12 of 16 for:    "Acute T Cell Leukemia" | "Dexamethasone acetate"

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 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
Study Start Date : August 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : June 2025


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



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 ]


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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

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


Contacts
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Contact: Nicola Gökbuget, Dr. med. +496963016365 goekbuget@em.uni-frankfurt.de
Contact: GMALL Study center +496963016366 gmall@em.uni-frankfurt.de

Locations
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Germany
University Hospital of Frankfurt (Main) Recruiting
Frankfurt (Main), Germany, 60590
Sponsors and Collaborators
Goethe University
Investigators
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Principal Investigator: Nicola Gökbuget, Dr. med. University Hospital of Frankfurt (Main)

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Responsible Party: Nicola Goekbuget, GMALL Head, Goethe University
ClinicalTrials.gov Identifier: NCT02881086     History of Changes
Other Study ID Numbers: GMALL08_2013
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
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:
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Dexamethasone
Dexamethasone acetate
BB 1101
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
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Cyclophosphamide
Rituximab
Methotrexate
Fludarabine
Fludarabine phosphate
Vincristine
Imatinib Mesylate
Doxorubicin
Liposomal doxorubicin
Daunorubicin