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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

Tracking Information
First Submitted Date  ICMJE July 31, 2019
First Posted Date  ICMJE October 10, 2019
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE June 24, 2019
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2019)
  • 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),
  • 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);
  • 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);
  • 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);
  • Measurement of efficacy variables, Rate of relapse (RR) [ Time Frame: 1 year after SCT ]
    safety item
  • Measurement of efficacy variables, Rate of treatment-related mortality [ Time Frame: 1 year after SCT ]
    treatment-related death divided by the number of patients
  • Rate of event free survival at 1 year (EFS) [ Time Frame: 1 year after SCT ]
    safety item
  • Measurement of efficacy variables, Rate of overall survival at 1 year (OS) [ Time Frame: 1 year after SCT ]
    safety item
  • Measurement of efficacy variables, Rate of non-relapse mortality (NRM) [ Time Frame: 1year after SCT ]
    safety item
  • Measurement of efficacy variables, Causes of death [ Time Frame: 1year after SCT ]
    safety item
  • 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
  • Measurement of efficacy variables, Adverse events (AEs) grade 3 and 4 [ Time Frame: until about day 100 after SCT. ]
    safety item
  • Measurement of efficacy variables, Serious adverse events (SAEs) [ Time Frame: until about day 100 after SCT. ]
    safety item
  • Measurement of number of blood cells [ Time Frame: 1year after SCT ]
    recovery of White blood cells and platelets
  • Measurement of efficacy variables, Rate of infections [ Time Frame: 1year after SCT ]
    safety item
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ASTRAL- a Clinical Study to Assess the Efficacy and Toxicity of High-dose Chemotherapy
Official Title  ICMJE 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
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Aggressive Non-hodgkin Lymphoma (aNHL)
  • Lymphoma, B-Cell
  • Lymphoma, T-Cell
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: alloSCT
defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 8, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2021
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

      -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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'
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04121507
Other Study ID Numbers  ICMJE ASTRAL / GLA-aNHL-R1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GWT-TUD GmbH
Study Sponsor  ICMJE GWT-TUD GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bertram Glass, Prof. Dr. Helios Klinikum Berlin-Buch
PRS Account GWT-TUD GmbH
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP