- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121507
ASTRAL- a Clinical Study to Assess the Efficacy and Toxicity of High-dose Chemotherapy
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
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Augsburg, Germany
- Klinikum Augsburg, Medizinische Klinik II
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Bochum, Germany, 44892
- Medizinisches Universitätsklinikum
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Chemnitz, Germany, 09116
- Klinikum Chemnitz gGmbH
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Dresden, Germany
- Universitätsklinikum Carl Gustav Carus Dresden, Medzinische Klinik I
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Düsseldorf, Germany, 40225
- Universitäsklinikum Düsseldorf
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Göttingen, Germany, 37075
- Universitätsmedizin Göttingen Klinik für Hämatologie/Med. Onkologie
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Halle, Germany, 06120
- Universitätsklinikum Halle
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Hamburg, Germany, 20246
- Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie, Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation
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Heidelberg, Germany, 69120
- Universitätsklinikum Heidelberg, Medizinische Klinik, Innere Medizin V
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Jena, Germany, 07747
- Universitätsklinikum Jena, Klinik für Innere Medizin, Abtl. Hämatologie und Innternistische Onkologie
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Münster, Germany, 48149
- Universitätsklinikum Münster, KMT-Zentrum/ Med. Klinik A
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Stuttgart, Germany, 70174
- Klinikum Stuttgart
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Brandenburg
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Berlin, Brandenburg, Germany, 13125
- HELIOS Klinik Berlin-Buch, Klinik für Hämatologie und Stammzelltransplantation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Subjects must fulfill all of the following criteria to be included in this trial:
- Provision of written informed consent and specifically the consent to the collection and processing of health-related data
- Age: 18 years and older
- Gender: Male and female patients
- Histology
Diagnosis of relapsed or primary progressive aggressive B- or T-cell lymphoma including:
- B-Cell non-hodgkin lymphoma (B-NHL) or
- T-Cell non-hodgkin lymphoma (T-NHL):
- Staging at relapse or progression (data should not be older than 4 weeks):
- Staging after 2 or 3 cycles of salvage treatment:
- Donor availability:
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
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
- Females of non-childbearing potential:
Exclusion Criteria:
Subjects are to be excluded from the study if they display any of the following criteria:
- Pregnant females; lactating women must end breast feeding before start of study treatment
- Serious accompanying disorder or impaired organ function
- Central nervous system (CNS) involvement of lymphoma - to be examined in case of clinical symptoms
- History of severe cardiac diseases, and cardiac function impairment
- Severe kidney disease
- HIV-positivity
- Hepatitis B and C as defined by seropositivity
- Patients under legal guardianship regarding medical decisions
- Ongoing treatment or study procedures within any other clinical trial with the exception of follow up
- Ongoing exclusion periods of other clinical studies after end of treatment
- 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
- Subjects with known hypersensitivity to the study drugs
- 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
- Commitment to an institution by virtue of an order issued either by the judicial or the administrative authorities
- Dependency on the sponsor, trial site or investigator
Additional exclusion criteria with respect to summary of product characteristics (SmPC) of the investigational medical product (IMPs) fludarabine, thiotepa, cyclophosphamide:
- Known hypersensitivity to fludarabine, thiotepa, cyclophosphamide or one of their metabolites
- Renal impairment
- Decompensated haemolytic anaemia
- Concurrent application of vital vaccines
- Cystitis
- Renal tract obstruction
- Active and uncontrolled infection
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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: alloSCT
defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)
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High-dose therapy (HDT) prior to alloSCT will consist of FTC
Other Names:
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of efficacy variables, Rate of Progression free survival (PFS)
Time Frame: 1 year after SCT
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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).
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1 year after SCT
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of efficacy variables, Rate of complete remissions (CR)
Time Frame: 1 year after stem cell transplantation (SCT)
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Number of complete remissions divided by the number of patients (CR),
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1 year after stem cell transplantation (SCT)
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Measurement of efficacy variables, Rate of partial remissions (PR)
Time Frame: 1 year after SCT
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Number of partial remissions divided by the number of patients (PR);
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1 year after SCT
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Measurement of efficacy variables, Rate of complete and partial remissions (ORR)
Time Frame: 1 year after SCT
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Number of complete and partial remissions divided by the number of patients (ORR);
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1 year after SCT
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Measurement of efficacy variables, Rate of progressive diseases (PD)
Time Frame: 1 year after SCT
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Number of progressive diseases after SCT divided by the number of patients (PD);
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1 year after SCT
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Measurement of efficacy variables, Rate of relapse (RR)
Time Frame: 1 year after SCT
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safety item
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1 year after SCT
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Measurement of efficacy variables, Rate of treatment-related mortality
Time Frame: 1 year after SCT
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treatment-related death divided by the number of patients
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1 year after SCT
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Rate of event free survival at 1 year (EFS)
Time Frame: 1 year after SCT
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safety item
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1 year after SCT
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Measurement of efficacy variables, Rate of overall survival at 1 year (OS)
Time Frame: 1 year after SCT
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safety item
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1 year after SCT
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Measurement of efficacy variables, Rate of non-relapse mortality (NRM)
Time Frame: 1year after SCT
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safety item
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1year after SCT
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Measurement of efficacy variables, Causes of death
Time Frame: 1year after SCT
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safety item
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1year after SCT
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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)
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safety item
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until the last Follow-Up Visit ( 1-2 Year after SCT)
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Measurement of efficacy variables, Adverse events (AEs) grade 3 and 4
Time Frame: until about day 100 after SCT.
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safety item
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until about day 100 after SCT.
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Measurement of efficacy variables, Serious adverse events (SAEs)
Time Frame: until about day 100 after SCT.
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safety item
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until about day 100 after SCT.
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Measurement of number of blood cells
Time Frame: 1year after SCT
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recovery of White blood cells and platelets
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1year after SCT
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Measurement of efficacy variables, Rate of infections
Time Frame: 1year after SCT
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safety item
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1year after SCT
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bertram Glass, Prof. Dr., Helios Klinikum Berlin-Buch
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Aggression
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Fludarabine
- Thiotepa
Other Study ID Numbers
- ASTRAL / GLA-aNHL-R1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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