Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ASTRAL- a Clinical Study to Assess the Efficacy and Toxicity of High-dose Chemotherapy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04121507
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Aggressive Non-hodgkin Lymphoma (aNHL) Lymphoma, B-Cell Lymphoma, T-Cell Drug: High dose chemotherapy before allogeneic stem cell transplantation (alloSCT) Procedure: Bone marrow histology Diagnostic Test: clinical and laboratory parameters Diagnostic Test: PET-CT or CT Phase 2

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Prospective Phase II Clinical Study to Assess the Efficacy and Toxicity of High-dose Chemotherapy Followed by Allogeneic Stem Cell Transplantation as Treatment of Primary Progressive and Relapsed Aggressive Non-Hodgkin Lymphoma
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: alloSCT
defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)
Drug: High dose chemotherapy before allogeneic stem cell transplantation (alloSCT)
High-dose therapy (HDT) prior to alloSCT will consist of FTC
Other Name: fludarabine, thiotepa ,cyclophosphamide (FTC)

Procedure: Bone marrow histology
Bone marrow histology at staging and restaging is only mandatory if the bone marrow was initially involved

Diagnostic Test: clinical and laboratory parameters
During staging and restaging examinations, all clinical and laboratory parameters relevant for therapy.

Diagnostic Test: PET-CT or CT
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.




Primary Outcome Measures :
  1. Measurement of efficacy variables, Rate of Progression free survival (PFS) [ Time Frame: 1 year after SCT ]
    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).


Secondary Outcome Measures :
  1. Measurement of efficacy variables, Rate of complete remissions (CR) [ Time Frame: 1 year after stem cell transplantation (SCT) ]
    Number of complete remissions divided by the number of patients (CR),

  2. Measurement of efficacy variables, Rate of partial remissions (PR) [ Time Frame: 1 year after SCT ]
    Number of partial remissions divided by the number of patients (PR);

  3. Measurement of efficacy variables, Rate of complete and partial remissions (ORR) [ Time Frame: 1 year after SCT ]
    Number of complete and partial remissions divided by the number of patients (ORR);

  4. Measurement of efficacy variables, Rate of progressive diseases (PD) [ Time Frame: 1 year after SCT ]
    Number of progressive diseases after SCT divided by the number of patients (PD);

  5. Measurement of efficacy variables, Rate of relapse (RR) [ Time Frame: 1 year after SCT ]
    safety item

  6. Measurement of efficacy variables, Rate of treatment-related mortality [ Time Frame: 1 year after SCT ]
    treatment-related death divided by the number of patients

  7. Rate of event free survival at 1 year (EFS) [ Time Frame: 1 year after SCT ]
    safety item

  8. Measurement of efficacy variables, Rate of overall survival at 1 year (OS) [ Time Frame: 1 year after SCT ]
    safety item

  9. Measurement of efficacy variables, Rate of non-relapse mortality (NRM) [ Time Frame: 1year after SCT ]
    safety item

  10. Measurement of efficacy variables, Causes of death [ Time Frame: 1year after SCT ]
    safety item

  11. Measurement of efficacy variables, Incidence and severity of acute and chronic graft versus host disease (GvHD); [ Time Frame: until the last Follow-Up Visit ( 1-2 Year after SCT) ]
    safety item

  12. Measurement of efficacy variables, Adverse events (AEs) grade 3 and 4 [ Time Frame: until about day 100 after SCT. ]
    safety item

  13. Measurement of efficacy variables, Serious adverse events (SAEs) [ Time Frame: until about day 100 after SCT. ]
    safety item

  14. Measurement of number of blood cells [ Time Frame: 1year after SCT ]
    recovery of White blood cells and platelets

  15. Measurement of efficacy variables, Rate of infections [ Time Frame: 1year after SCT ]
    safety item



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must fulfill all of the following criteria to be included in this trial:

  1. Provision of written informed consent and specifically the consent to the collection and processing of health-related data
  2. Age: 18 years and older
  3. Gender: Male and female patients
  4. Histology
  5. Diagnosis of relapsed or primary progressive aggressive B- or T-cell lymphoma including:

    1. B-Cell non-hodgkin lymphoma (B-NHL) or
    2. T-Cell non-hodgkin lymphoma (T-NHL):
  6. Staging at relapse or progression (data should not be older than 4 weeks):
  7. Staging after 2 or 3 cycles of salvage treatment:
  8. Donor availability:
  9. Females of childbearing potential (FCBP) must:

    • Understand the potential teratogenic risk to the unborn child
    • Understand the need and agree to utilize two reliable forms of contraception
    • Understand and agree to inform the investigator if a change or stop of method of contraception is needed
    • Be capable of complying with effective contraceptive measures
    • Be informed and understand the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy
    • Understand the need to commence the study treatment as soon as study drug is dispensed following a negative pregnancy test
    • Understand the need and accept to undergo pregnancy testing based on the frequency outlined in this protocol
    • Agree to abstain from breastfeeding during study participation
  10. Males must:

    • Agree to use a latex condom during any sexual contact with females of childbearing potential
    • Agree to refrain from donating semen or sperm while on the study drugs and should seek for sperm cryopreservation before therapy is started and should not father a child while treated and during one year after end of study treatment
  11. Females of non-childbearing potential:

Exclusion Criteria:

Subjects are to be excluded from the study if they display any of the following criteria:

  1. Pregnant females; lactating women must end breast feeding before start of study treatment
  2. Serious accompanying disorder or impaired organ function
  3. Central nervous system (CNS) involvement of lymphoma - to be examined in case of clinical symptoms
  4. History of severe cardiac diseases, and cardiac function impairment
  5. Severe kidney disease
  6. HIV-positivity
  7. Hepatitis B and C as defined by seropositivity
  8. Patients under legal guardianship regarding medical decisions
  9. Ongoing treatment or study procedures within any other clinical trial with the exception of follow up
  10. Ongoing exclusion periods of other clinical studies after end of treatment
  11. In patients tested: Metabolic Computer tomography (CR) in a positron emission tomography-Computer tomography (PET-CT) scan after the last cycle of therapy prior to planned SCT
  12. Subjects with known hypersensitivity to the study drugs
  13. Criteria which in the opinion of the investigator precluded participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
  14. Commitment to an institution by virtue of an order issued either by the judicial or the administrative authorities
  15. Dependency on the sponsor, trial site or investigator
  16. Additional exclusion criteria with respect to summary of product characteristics (SmPC) of the investigational medical product (IMPs) fludarabine, thiotepa, cyclophosphamide:

    1. Known hypersensitivity to fludarabine, thiotepa, cyclophosphamide or one of their metabolites
    2. Renal impairment
    3. Decompensated haemolytic anaemia
    4. Concurrent application of vital vaccines
    5. Cystitis
    6. Renal tract obstruction
    7. Active and uncontrolled infection
    8. Notice: myelosuppression and impaired hematopoietic function is not an exclusion criterion as this usual contraindication to the application to any of the IMPs will be overcome by the stem cell transplantation following conditioning 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): NCT04121507


Contacts
Layout table for location contacts
Contact: Katrin Linke, Dr. : +49 (0) 351 25933 176 Katrin.linke@gwtonline.de
Contact: Carsta Köhler, Dr. + +49 (0) 351 25933 190 'bertram.glass@helios-gesundheit.de'

Locations
Layout table for location information
Germany
HELIOS Klinik Berlin-Buch, Klinik für Hämatologie und Stammzelltransplantation Recruiting
Berlin, Brandenburg, Germany, 13125
Contact: Bertram Glaß, Prof. Dr.    + 49 (0) 30 940 11 21 02    'bertram.glass@helios-gesundheit.de'   
Principal Investigator: Bertram Glaß         
Klinikum Augsburg, Medizinische Klinik II Not yet recruiting
Augsburg, Germany
Contact: Christoph Schmid, Dr.    + 49 (0) 821 / 400 37 15    christoph.schmid@klinikum-augsburg.de   
Contact: , Dr.         
Principal Investigator: Christoph Schmid, Dr.         
Medizinisches Universitätsklinikum Recruiting
Bochum, Germany, 44892
Contact: Roland Schroers       roland.schroers@rub.de   
Principal Investigator: Roland Schroers, Prof.Dr         
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany, 09116
Contact: Mathias Hänel, Dr.       m.haenel@skc.de   
Principal Investigator: Mathias Hänel, Dr.         
Universitätsklinikum Carl Gustav Carus Dresden, Medzinische Klinik I Recruiting
Dresden, Germany
Contact: Friedrich Stölzel, Dr.    + 49 (0) 351 45 8 25 83      
Principal Investigator: Friedrich Stölzel, Dr.         
Universitäsklinikum Düsseldorf Not yet recruiting
Düsseldorf, Germany, 40225
Contact: Guido Kobbe, Prof.Dr.       Kobbe@med.uni-duesseldorf.de   
Principal Investigator: Guido Kobbe, Prof.Dr.         
Universitätsmedizin Göttingen Klinik für Hämatologie/Med. Onkologie Recruiting
Göttingen, Germany, 37075
Contact: Justin Hasenkamp, Dr.    +49 (0) 5513914289    justin.hasenkamp@med.uni-goettingen.de   
Principal Investigator: Justin Hasenkamp, Dr.         
Universitätsklinikum Halle Recruiting
Halle, Germany, 06120
Contact: Lutz Müller, Dr.       lutz.mueller@uk-halle.de   
Principal Investigator: Lutz Müller, Dr.         
Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie, Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation Not yet recruiting
Hamburg, Germany, 20246
Contact: Christine Wolschke, Dr.    + 49 (0) 40 / 741 05 81 25    wolschke@uke.de   
Principal Investigator: Christine Wolschke, Dr.         
Universitätsklinikum Heidelberg, Medizinische Klinik, Innere Medizin V Not yet recruiting
Heidelberg, Germany, 69120
Contact: Peter Dreger, Prof. Dr.    +49 (0) 6221 / 56 82 83    peter.dreger@med.uni-heidelberg.de   
Principal Investigator: Peter Dreger, Prof. Dr.         
Universitätsklinikum Jena, Klinik für Innere Medizin, Abtl. Hämatologie und Innternistische Onkologie Recruiting
Jena, Germany, 07747
Contact: Inken Hilgendorf, Dr.    +49 (0)3641 / 932 46 64      
Principal Investigator: Inken Hilgendorf, Dr.         
Universitätsklinikum Münster, KMT-Zentrum/ Med. Klinik A Not yet recruiting
Münster, Germany, 48149
Contact: Matthias Stelljes, Prof. Dr.    + 49 (0) 251 / 835 28 01    matthias.stelljes@ukmuenster.de   
Principal Investigator: Matthias Stelljes, Prof. Dr.         
Klinikum Stuttgart Recruiting
Stuttgart, Germany, 70174
Contact: Gerald Illerhaus, Prof.Dr.       g.illerhaus@klinikum-stuttgart.de   
Principal Investigator: Gerald Illerhaus, Prof.Dr.         
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
Layout table for investigator information
Principal Investigator: Bertram Glass, Prof. Dr. Helios Klinikum Berlin-Buch

Layout table for additonal information
Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT04121507     History of Changes
Other Study ID Numbers: ASTRAL / GLA-aNHL-R1
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, T-Cell
Aggression
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Fludarabine
Antineoplastic Agents