跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/ISRCTN99217456
ISRCTN99217456已完成3 期

Purine-alkylator combination in follicular lymphoma immuno-chemotherapy for older patients: a phase III randomised controlled trial

niversity of Liverpool (UK)0 个研究点目标入组 680 人开始时间: 2009年3月3日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
680
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •1. Histologically confirmed follicular lymphoma, grade 1, 2, and 3a with material available for central review
  • •2. Ann Arbor stage II - IV, i.e. all patients except those with strictly localised disease for whom local radiotherapy would be appropriate. Lymph nodes should be considered pathologically enlarged if the long axis is more than 1.5 cm regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is more than 1.0 cm.
  • •3. Aged 60 years or over (or less than 60 but more intensive chemotherapy considered inappropriate due to co-morbidity), either sex
  • •4. At least one of the following British National Lymphoma Investigation (BNLI) criteria for initiation of treatment:
  • •4.1. Rapid generalised disease progression in the preceding 3 months
  • •4.2. Life threatening organ involvement
  • •4.3. Renal of macroscopic liver infiltration
  • •4.4. Bone lesions
  • •4.5. Presence of systemic symptoms or pruritus
  • •4.6. Haemoglobin less than 10 g/dL or whole blood cell count (WBC) less than 3.0 × 10^9/L or platelet count less than 100 × 10^9/L due to marrow involvement
  • •5. Adequate haematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) within 28 days prior to registration:
  • •5.1. Haemoglobin greater than or equal to 8.0 g/dL
  • •5.2. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
  • •5.3. Platelet count greater than or equal to 100 x 10^9/L
  • •6. Written informed consent

排除标准

  • •1. Prior anti-lymphoma treatment
  • •2. Overt transformation to diffuse large B-cell lymphoma
  • •3. World Health Organization (WHO) performance status 3 or 4
  • •4. Creatinine clearance less than 30 ml/min
  • •5. Serum bilirubin more than twice upper limit of normal (unless due to lymphoma)
  • •6. Life expectancy less than 12 months
  • •7. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. Patients with any serological evidence of current or past exposure to HIV, hepatitis B or hepatitis C are excluded unless the serological findings are clearly due to vaccination.
  • •8. Allergy to murine proteins
  • •9. Grade 3b follicular lymphoma
  • •10. Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis)
  • •11. Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to less than 20 mg/day prednisolone
  • •12. Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer
  • •13. Major surgery (excluding lymph node biopsy) within 28 days prior to registration
  • •14. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease)
  • •15. Treatment within a clinical trial within 30 days prior to trial entry
  • •16. Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent
  • •17. Adult patient under tutelage (not competent to sign informed consent)

研究者

发起方
niversity of Liverpool (UK)

相似试验

进行中（未招募）
不适用
This trial is looking at a combination of rituximab and chemotherapy as a treatment for follicular lymphoma in patients 60 years of age and older.
EUCTR2008-004759-31-GBniversity of Liverpool (lead sponsor, the trial is co-sponsored)
尚未招募
不适用
Follicular Fluid Anti-Mullerian Hormone (AMH) levels and Assisted Reproductive Technology (ART) outcomes.
CTRI/2019/05/019433il
尚未招募
不适用
Treatment for aqueous deficiency dry eyes
CTRI/2020/12/029574V Prasad Eye Institute
进行中（未招募）
1 期
al-IRI with 5-fluorouracil (5-FU) and leucovorin or gemcitabine plus cisplatin in advanced biliary-tract cancerocally advanced or metastatic, non resectable, adenocarcinoma of the biliary tract including intrahepatic and extrahepatic bile ductMedDRA version: 21.1Level: LLTClassification code 10025734Term: Malignant neoplasm of biliary tract, part unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10008593Term: CholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10008594Term: Cholangiocarcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10028982Term: Neoplasm biliary tractSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10077846Term: Cholangiocarcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2016-002467-34-DEAIO-Studien-gGmbH92
已完成
不适用
Confirmation of lymphatic system with indocyanine greelung malignant tumor
JPRN-UMIN000027878Kansai Medical University Medical Center200