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

NCT04121507 | Completed Phase 2

• 1 other identifier: ASTRAL / GLA-aNHL-R1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 13

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year after SCT

Secondary Outcomes (15)

• Measurement of efficacy variables, Rate of complete remissions (CR)

  1 year after stem cell transplantation (SCT)

• Measurement of efficacy variables, Rate of partial remissions (PR)

  1 year after SCT

• Measurement of efficacy variables, Rate of complete and partial remissions (ORR)

  1 year after SCT

• Measurement of efficacy variables, Rate of progressive diseases (PD)

  1 year after SCT

• Measurement of efficacy variables, Rate of relapse (RR)

  1 year after SCT

Study Arms (1)

alloSCT

EXPERIMENTAL

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

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

Interventions

High dose chemotherapy before allogeneic stem cell transplantation (alloSCT) DRUG

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

Also known as: fludarabine, thiotepa ,cyclophosphamide (FTC)

alloSCT

Bone marrow histology PROCEDURE

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

alloSCT

clinical and laboratory parameters DIAGNOSTIC_TEST

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

alloSCT

PET-CT or CT 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.

alloSCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Study Sites (13)

HELIOS Klinik Berlin-Buch, Klinik für Hämatologie und Stammzelltransplantation

Berlin, Brandenburg, 13125, Germany

Location

Klinikum Augsburg, Medizinische Klinik II

Augsburg, Germany

Location

Medizinisches Universitätsklinikum

Bochum, 44892, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden, Medzinische Klinik I

Dresden, Germany

Location

Universitäsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsmedizin Göttingen Klinik für Hämatologie/Med. Onkologie

Göttingen, 37075, Germany

Location

Universitätsklinikum Halle

Halle, 06120, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie, Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation

Hamburg, 20246, Germany

Location

Universitätsklinikum Heidelberg, Medizinische Klinik, Innere Medizin V

Heidelberg, 69120, Germany

Location

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

Jena, 07747, Germany

Location

Universitätsklinikum Münster, KMT-Zentrum/ Med. Klinik A

Münster, 48149, Germany

Location

Klinikum Stuttgart

Stuttgart, 70174, Germany

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, T-Cell

Interventions

fludarabine; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Bertram Glass, Prof. Dr.

  Helios Klinikum Berlin-Buch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: October 10, 2019
• Study Start: June 24, 2019
• Primary Completion: March 30, 2022
• Study Completion: February 2, 2023
• Last Updated: May 24, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (13)