A Prospective Phase II Clinical Study to Assess the Efficacy and Toxicity of High-dose Chemotherapy Followed by Allogeneic Stem Cell Transplantation as Treatment of Primary Progressive and Relapsed Aggressive Non-Hodgkin Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- High dose chemotherapy before allogeneic stem cell transplantation (alloSCT)
- Conditions
- Aggressive Non-hodgkin Lymphoma (aNHL)
- Sponsor
- GWT-TUD GmbH
- Enrollment
- 60
- Locations
- 13
- Primary Endpoint
- Measurement of efficacy variables, Rate of Progression free survival (PFS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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:
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
Arms & Interventions
alloSCT
defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)
Intervention: High dose chemotherapy before allogeneic stem cell transplantation (alloSCT)
alloSCT
defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)
Intervention: Bone marrow histology
alloSCT
defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)
Intervention: clinical and laboratory parameters
alloSCT
defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)
Intervention: PET-CT or CT
Outcomes
Primary Outcomes
Measurement of efficacy variables, Rate of Progression free survival (PFS)
Time Frame: 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 Outcomes
- Measurement of efficacy variables, Rate of overall survival at 1 year (OS)(1 year after SCT)
- Measurement of efficacy variables, Rate of complete remissions (CR)(1 year after stem cell transplantation (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)
- Measurement of efficacy variables, Rate of treatment-related mortality(1 year after SCT)
- Rate of event free survival at 1 year (EFS)(1 year after SCT)
- 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))
- Measurement of efficacy variables, Causes of death(1year after SCT)
- Measurement of efficacy variables, Adverse events (AEs) grade 3 and 4(until about day 100 after SCT.)
- Measurement of efficacy variables, Rate of complete and partial remissions (ORR)(1 year after SCT)
- Measurement of efficacy variables, Serious adverse events (SAEs)(until about day 100 after SCT.)
- Measurement of number of blood cells(1year after SCT)
- Measurement of efficacy variables, Rate of partial remissions (PR)(1 year after SCT)
- Measurement of efficacy variables, Rate of non-relapse mortality (NRM)(1year after SCT)
- Measurement of efficacy variables, Rate of infections(1year after SCT)