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

NCT ID: NCT04121507

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2023-02-02

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.

Conditions

Aggressive Non-hodgkin Lymphoma (aNHL); Lymphoma, B-Cell; Lymphoma, T-Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

alloSCT

defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)

Group Type: EXPERIMENTAL

High dose chemotherapy before allogeneic stem cell transplantation (alloSCT)

Intervention Type: DRUG

High-dose therapy (HDT) prior to alloSCT will consist of FTC

Bone marrow histology

Intervention Type: PROCEDURE

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

clinical and laboratory parameters

Intervention Type: DIAGNOSTIC_TEST

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

PET-CT or CT

Intervention Type: DIAGNOSTIC_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.

Interventions

High dose chemotherapy before allogeneic stem cell transplantation (alloSCT)

High-dose therapy (HDT) prior to alloSCT will consist of FTC

Intervention Type: DRUG

Bone marrow histology

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

Intervention Type: PROCEDURE

clinical and laboratory parameters

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

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

fludarabine, thiotepa ,cyclophosphamide (FTC)

Eligibility 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

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.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GWT-TUD GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertram Glass, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Helios Klinikum Berlin-Buch

Locations

HELIOS Klinik Berlin-Buch, Klinik für Hämatologie und Stammzelltransplantation

Berlin, Brandenburg, Germany

Klinikum Augsburg, Medizinische Klinik II

Augsburg, , Germany

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

Universitätsklinikum Jena, Klinik für Innere Medizin, Abtl. Hämatologie und Innternistische Onkologie

Jena, , Germany

Universitätsklinikum Münster, KMT-Zentrum/ Med. Klinik A

Münster, , Germany

Klinikum Stuttgart

Stuttgart, , Germany

Countries

Germany

Other Identifiers

ASTRAL / GLA-aNHL-R1

Identifier Type: -

Identifier Source: org_study_id