A prospective Phase II clinical study to assess the efficacy and toxicity of high dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (allo- or autoSCT) as treatment of primary progressive and relapsed aggressive Non-Hodgkin Lymphoma (NHL) - ASTRAL
This is a clinical study to assess the treatment (efficacy and toxicity) with a high dosed chemotherapy followed by stem cell transplantation in patients suffering from primary progressive and relapsed aggressive Non-Hodgkin Lymphoma (NHL) After end of the active study phase, patients will receive further standard medical care at the discretion of the treating physician. The clinical consultants will provide advice on further treatment if requested.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
60
High-dose therapy (HDT) prior to alloSCT will consist of FTC
Bone marrow histology at staging and restaging is only mandatory if the bone marrow was initially involved
During staging and restaging examinations, all clinical and laboratory parameters relevant for therapy.
HELIOS Klinik Berlin-Buch, Klinik für Hämatologie und Stammzelltransplantation
Berlin, Brandenburg, Germany
Klinikum Augsburg, Medizinische Klinik II
Augsburg, Germany
Measurement of efficacy variables, Rate of Progression free survival (PFS)
To compare a defined high dose therapy (HDT) with study medication followed by alloSCT lead to treatment results in terms of PFS, that are better than results obtained with high-dose therapy and autoSCT in a comparable Patient Population ( historical data).
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of complete remissions (CR)
Number of complete remissions divided by the number of patients (CR),
Time frame: 1 year after stem cell transplantation (SCT)
Measurement of efficacy variables, Rate of partial remissions (PR)
Number of partial remissions divided by the number of patients (PR);
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of complete and partial remissions (ORR)
Number of complete and partial remissions divided by the number of patients (ORR);
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of progressive diseases (PD)
Number of progressive diseases after SCT divided by the number of patients (PD);
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of relapse (RR)
safety item
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of treatment-related mortality
treatment-related death divided by the number of patients
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Metabolic CR in a PET-CT scan after the last cycle of therapy prior to planned SCT. Consists preferably of a PET-CT or a CT scan according to local practice and other appropriate diagnostic procedures with respect to the sites of primary involvement.
Medizinisches Universitätsklinikum
Bochum, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Universitätsklinikum Carl Gustav Carus Dresden, Medzinische Klinik I
Dresden, Germany
Universitäsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsmedizin Göttingen Klinik für Hämatologie/Med. Onkologie
Göttingen, Germany
Universitätsklinikum Halle
Halle, Germany
Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie, Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation
Hamburg, Germany
Universitätsklinikum Heidelberg, Medizinische Klinik, Innere Medizin V
Heidelberg, Germany
...and 3 more locations
Time frame: 1 year after SCT
Rate of event free survival at 1 year (EFS)
safety item
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of overall survival at 1 year (OS)
safety item
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of non-relapse mortality (NRM)
safety item
Time frame: 1year after SCT
Measurement of efficacy variables, Causes of death
safety item
Time frame: 1year after SCT
Measurement of efficacy variables, Incidence and severity of acute and chronic graft versus host disease (GvHD);
safety item
Time frame: until the last Follow-Up Visit ( 1-2 Year after SCT)
Measurement of efficacy variables, Adverse events (AEs) grade 3 and 4
safety item
Time frame: until about day 100 after SCT.
Measurement of efficacy variables, Serious adverse events (SAEs)
safety item
Time frame: until about day 100 after SCT.
Measurement of number of blood cells
recovery of White blood cells and platelets
Time frame: 1year after SCT
Measurement of efficacy variables, Rate of infections
safety item
Time frame: 1year after SCT