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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    70
  • sponsor
    GWT-TUD GmbH
Updated on 9 August 2021
ct scan
stem cell transplantation
cell transplantation
cancer chemotherapy
high dose chemotherapy

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

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.

Details
Condition B-Cell Lymphoma, T-Cell Lymphoma, Lymphoma, B-Cell, b-cell lymphomas, b cell lymphomas, b cell lymphoma, t cell lymphoma, Aggressive Non-hodgkin Lymphoma (aNHL), Aggressive Non-hodgkin Lymphoma (aNHL), Aggressive Non-hodgkin Lymphoma (aNHL), Aggressive Non-hodgkin Lymphoma (aNHL)
Treatment High dose chemotherapy before allogeneic stem cell transplantation (alloSCT), Bone marrow histology, clinical and laboratory parameters, PET-CT or CT
Clinical Study IdentifierNCT04121507
SponsorGWT-TUD GmbH
Last Modified on9 August 2021

Eligibility

Yes No Not Sure

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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