MedTrace Logo

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

NCT04121507 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-05-24

No results posted yet for this study

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

Interventions

DRUG

High dose chemotherapy before allogeneic stem cell transplantation (alloSCT)

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

Sponsors & Collaborators

  • GWT-TUD GmbH

    lead OTHER

Principal Investigators

  • Bertram Glass, Prof. Dr. · Helios Klinikum Berlin-Buch

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2022-03-30
Completion
2023-02-02

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04121507 on ClinicalTrials.gov