Aggressive Non-hodgkin Lymphoma (aNHL)Phase 2NCT04121507
ASTRAL- a Clinical Study to Assess the Efficacy and Toxicity of High-dose Chemotherapy
A Phase 2 study testing High dose chemotherapy before allogeneic stem cell transplantation (alloSCT), Bone marrow histology and clinical and laboratory parameters in people with Aggressive Non-hodgkin Lymphoma (aNHL) and Lymphoma, B-Cell, run by GWT-TUD GmbH at 13 sites in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggressive Non-hodgkin Lymphoma (aNHL), Lymphoma, B-Cell, Lymphoma, T-Cell
- What is being tested?
- High dose chemotherapy before allogeneic stem cell transplantation (alloSCT), Bone marrow histology and clinical and laboratory parameters
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 13 sitesGermany
- Study dates
- 24 Jun 2019to 2 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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:
Who cannot join
- 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
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- 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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Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Klinikum Augsburg, Medizinische Klinik II
Augsburg
HELIOS Klinik Berlin-Buch, Klinik für Hämatologie und Stammzelltransplantation
Berlin, Brandenburg, 13125
Medizinisches Universitätsklinikum
Bochum, 44892
Klinikum Chemnitz gGmbH
Chemnitz, 09116
Universitätsklinikum Carl Gustav Carus Dresden, Medzinische Klinik I
Dresden
Universitäsklinikum Düsseldorf
Düsseldorf, 40225
Universitätsmedizin Göttingen Klinik für Hämatologie/Med. Onkologie
Göttingen, 37075
Universitätsklinikum Halle
Halle, 06120
Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie, Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation
Hamburg, 20246
Universitätsklinikum Heidelberg, Medizinische Klinik, Innere Medizin V
Heidelberg, 69120
Universitätsklinikum Jena, Klinik für Innere Medizin, Abtl. Hämatologie und Innternistische Onkologie
Jena, 07747
Universitätsklinikum Münster, KMT-Zentrum/ Med. Klinik A
Münster, 48149
Klinikum Stuttgart
Stuttgart, 70174
About this study
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
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
Read the 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.
- Being tested
- High dose chemotherapy before allogeneic stem cell transplantation (alloSCT), Bone marrow histology, clinical and laboratory parameters, PET-CT or CT
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose chemotherapy before allogeneic stem cell transplantation (alloSCT)Drug
Also called fludarabine, thiotepa ,cyclophosphamide (FTC)
High-dose therapy (HDT) prior to alloSCT will consist of FTC
Bone marrow histologyProcedure or surgery
Bone marrow histology at staging and restaging is only mandatory if the bone marrow was initially involved
clinical and laboratory parametersDiagnostic test
During staging and restaging examinations, all clinical and laboratory parameters relevant for therapy.
PET-CT or CTDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| alloSCT | Experimental | defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year after SCT
Secondary outcomes (15)
Measurement of efficacy variables, Rate of complete remissions (CR)
Number of complete remissions divided by the number of patients (CR),
Measured: 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);
Measured: 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);
Measured: 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);
Measured: 1 year after SCT
Measurement of efficacy variables, Rate of relapse (RR)
safety item
Measured: 1 year after SCT
Measurement of efficacy variables, Rate of treatment-related mortality
treatment-related death divided by the number of patients
Measured: 1 year after SCT
Rate of event free survival at 1 year (EFS)
safety item
Measured: 1 year after SCT
Measurement of efficacy variables, Rate of overall survival at 1 year (OS)
safety item
Measured: 1 year after SCT
Measurement of efficacy variables, Rate of non-relapse mortality (NRM)
safety item
Measured: 1year after SCT
Measurement of efficacy variables, Causes of death
safety item
Measured: 1year after SCT
Measurement of efficacy variables, Incidence and severity of acute and chronic graft versus host disease (GvHD);
safety item
Measured: until the last Follow-Up Visit ( 1-2 Year after SCT)
Measurement of efficacy variables, Adverse events (AEs) grade 3 and 4
safety item
Measured: until about day 100 after SCT.
Measurement of efficacy variables, Serious adverse events (SAEs)
safety item
Measured: until about day 100 after SCT.
Measurement of number of blood cells
recovery of White blood cells and platelets
Measured: 1year after SCT
Measurement of efficacy variables, Rate of infections
safety item
Measured: 1year after SCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start24 Jun 2019
- Primary completion30 Mar 2022
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive Non-hodgkin Lymphoma (aNHL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertram Glass, Prof. Dr., Principal investigator, Helios Klinikum Berlin-Buch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121507
- Sponsor's protocol ID
- ASTRAL / GLA-aNHL-R1
- Status last verified
- Apr 2022
- First submitted
- 31 Jul 2019
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04121507
- Acronym / sponsor ID
- ASTRAL / GLA-aNHL-R1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| alloSCT | Experimental | 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 CTdefined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose chemotherapy before allogeneic stem cell transplantation (alloSCT)Also: fludarabine, thiotepa ,cyclophosphamide (FTC)High-dose therapy (HDT) prior to alloSCT will consist of FTC | Drug | alloSCT |
| Bone marrow histologyBone marrow histology at staging and restaging is only mandatory if the bone marrow was initially involved | Procedure or surgery | alloSCT |
| clinical and laboratory parametersDuring staging and restaging examinations, all clinical and laboratory parameters relevant for therapy. | Diagnostic test | alloSCT |
| PET-CT or CTMetabolic 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. | Diagnostic test | alloSCT |
Primary outcome
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).
15 secondary outcomes
Measurement of efficacy variables, Rate of complete remissions (CR)
Time frame: 1 year after stem cell transplantation (SCT)
Measurement of efficacy variables, Rate of partial remissions (PR)
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of complete and partial remissions (ORR)
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of progressive diseases (PD)
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of relapse (RR)
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of treatment-related mortality
Time frame: 1 year after SCT
Rate of event free survival at 1 year (EFS)
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of overall survival at 1 year (OS)
Time frame: 1 year after SCT
Measurement of efficacy variables, Rate of non-relapse mortality (NRM)
Time frame: 1year after SCT
Measurement of efficacy variables, Causes of death
Time frame: 1year after SCT
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)
Measurement of efficacy variables, Adverse events (AEs) grade 3 and 4
Time frame: until about day 100 after SCT.
Measurement of efficacy variables, Serious adverse events (SAEs)
Time frame: until about day 100 after SCT.
Measurement of number of blood cells
Time frame: 1year after SCT
Measurement of efficacy variables, Rate of infections
Time frame: 1year after SCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
Related trials for Aggressive Non-hodgkin Lymphoma (aNHL)
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RecruitingPhase 2
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Aggressive B-cell Non-Hodgkin Lymphoma (aNHL), Relapsed or Refractory B-cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertram Glass, Prof. Dr. principal investigator
Helios Klinikum Berlin-Buch
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High dose chemotherapy before allogeneic stem cell transplantation (alloSCT), Bone marrow histology and clinical and laboratory parameters in people with Aggressive Non-hodgkin Lymphoma (aNHL) and Lymphoma, B-Cell, run by GWT-TUD GmbH at 13 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of efficacy variables, Rate of Progression free survival (PFS) (time frame: 1 year after SCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.