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

  • STATUS
    Not Recruiting
  • End date
    Jul 24, 2025
  • participants needed
    900
  • sponsor
    Goethe University
Updated on 10 October 2022
remission
stem cell transplantation
lymphoid leukemia
fludarabine
imatinib
cyclophosphamide
lymphoma
methotrexate
cytarabine
rituximab
lymphoblastic lymphoma
vincristine
cell transplantation
leukemia
lymphocytic leukemia
minimal residual disease
adult t-cell leukemia/lymphoma
mercaptopurine
daunorubicin
prednisolone
asparaginase
pegaspargase
b-cell acute lymphoblastic leukemia
induction therapy
residual tumor
dexamethasone
consolidation therapy
idarubicin
adriamycin
vp-16
vindesine

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.

Details
Condition Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
Treatment Rituximab, cyclophosphamide, methotrexate, Stem cell transplantation, cytarabine, Fludarabine, Dexamethasone, vincristine, Mercaptopurine, Idarubicin, Prednisolone, Imatinib, PEG-asparaginase, Vindesine, VP16, Adriamycin, Nelarabine, Cranial irradiation, Cranial irradiation, Daunorubicin (DNR)
Clinical Study IdentifierNCT02881086
SponsorGoethe University
Last Modified on10 October 2022

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