Aggressive Non-hodgkin Lymphoma (aNHL), Lymphoma, B-Cell, Lymphoma, T-Cell
Conditions
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.
Interventions
DRUGHigh dose chemotherapy before allogeneic stem cell transplantation (alloSCT)
High-dose therapy (HDT) prior to alloSCT will consist of FTC
PROCEDUREBone marrow histology
Bone marrow histology at staging and restaging is only mandatory if the bone marrow was initially involved
DIAGNOSTIC_TESTclinical and laboratory parameters
During staging and restaging examinations, all clinical and laboratory parameters relevant for therapy.
DIAGNOSTIC_TESTPET-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
GWT-TUD GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 16. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of efficacy variables, Rate of Progression free survival (PFS) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of efficacy variables, Rate of complete remissions (CR) | 1 year after stem cell transplantation (SCT) | Number of complete remissions divided by the number of patients (CR), |
| Measurement of efficacy variables, Rate of partial remissions (PR) | 1 year after SCT | Number of partial remissions divided by the number of patients (PR); |
| Measurement of efficacy variables, Rate of complete and partial remissions (ORR) | 1 year after SCT | Number of complete and partial remissions divided by the number of patients (ORR); |
| Measurement of efficacy variables, Rate of progressive diseases (PD) | 1 year after SCT | Number of progressive diseases after SCT divided by the number of patients (PD); |
| Measurement of efficacy variables, Rate of relapse (RR) | 1 year after SCT | safety item |
| Measurement of efficacy variables, Rate of treatment-related mortality | 1 year after SCT | treatment-related death divided by the number of patients |
| Rate of event free survival at 1 year (EFS) | 1 year after SCT | safety item |
| Measurement of efficacy variables, Rate of infections | 1year after SCT | safety item |
| Measurement of efficacy variables, Rate of non-relapse mortality (NRM) | 1year after SCT | safety item |
| Measurement of efficacy variables, Causes of death | 1year after SCT | safety item |
| Measurement of efficacy variables, Incidence and severity of acute and chronic graft versus host disease (GvHD); | until the last Follow-Up Visit ( 1-2 Year after SCT) | safety item |
| Measurement of efficacy variables, Adverse events (AEs) grade 3 and 4 | until about day 100 after SCT. | safety item |
| Measurement of efficacy variables, Serious adverse events (SAEs) | until about day 100 after SCT. | safety item |
| Measurement of number of blood cells | 1year after SCT | recovery of White blood cells and platelets |
| Measurement of efficacy variables, Rate of overall survival at 1 year (OS) | 1 year after SCT | safety item |
Countries
Germany
Outcome results
None listed