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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 60
- 试验地点
- 13
- 主要终点
- Measurement of efficacy variables, Rate of Progression free survival (PFS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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:
排除标准
- •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
- •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.
研究组 & 干预措施
alloSCT
defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)
干预措施: High dose chemotherapy before allogeneic stem cell transplantation (alloSCT) (Drug)
alloSCT
defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)
干预措施: Bone marrow histology (Procedure)
alloSCT
defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)
干预措施: clinical and laboratory parameters (Diagnostic Test)
alloSCT
defined high-dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (alloSCT)
干预措施: PET-CT or CT (Diagnostic Test)
结局指标
主要结局
Measurement of efficacy variables, Rate of Progression free survival (PFS)
时间窗: 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).
次要结局
- 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)