ISRCTN40303610已完成2 期
Phase II trial of alemtuzumab, dexamethasone and lenalidomide followed by randomisation to lenalidomide maintenance versus no further treatment for high-risk CLL (NCRI CLL210)
niversity of Liverpool (UK)0 个研究点目标入组 64 人开始时间: 2011年8月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
2017 Abstract results in https://livrepository.liverpool.ac.uk/3006822/ results 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32054653 results (added 17/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. CLL/SLL requiring treatment by IWCLL 2008 criteria
- •2. At least one of the following criteria should be met:
- •2.1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia
- •2.2. Massive (i.e. at least 6cm below the left costal margin) or progressive or symptomatic splenomegaly
- •2.3. Massive (i.e. at least 10cm in longest diameter) or progressive or symptomatic lymphadenopathy
- •2.4. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months from a baseline value of at least 30x109/l and not due to causes other than CLL.
- •2.5. Constitutional symptoms defined as at least 10% unintentional weight loss within the previous 6 months, significant fatigue preventing usual activities, or fever of at least 38°C for at least 2 weeks or night sweats for at least one month in the absence of infection
- •3. High risk CLL/SLL defined by at least one of the following criteria:
- •3.1. TP53 deletion or mutation affecting at least 20% of CLL cells
- •3.2. Resistant (SD/PD) to fludarabine-containing combination therapy
- •3.3. Relapse within 12 months of responding to fludarabine-containing combination therapy
- •3.4. No prior treatment with alemtuzumab or lenalidomide
- •4. CLL not known to be resistant to glucocorticoids
- •5. No more than 3 previous treatment episodes for CLL
- •6. WHO performance status 0-2
- •7. Aged at least 18 years
- •8. Written informed consent
- •9. Male and female participants
- •10.Lower age limit 18 years, no age limit
排除标准
- •1. Neutrophil count less than 0.5x109/l or platelet count less than 25x109/l
- •2. Uncontrolled auto-immune haemolytic anaemia or thrombocytopenia
- •3. Active infection
- •4. Active gastritis or peptic ulcer disease
- •5. Uncontrolled diabetes mellitus or hypertension
- •6. History of recurrent thromboembolism
- •7. Seropositivity for HIV, HCV or HBV (surface antigen or core antibody)
- •8. Renal impairment (creatinine clearance less than 30ml/min)
- •9. Hepatic impairment (serum bilirubin more than twice the upper limit of normal unless due to Gilbert's syndrome or CLL)
- •10. Concurrent treatment with glucocorticoids equivalent to more than prednisolone 20mg
- •11. Presence or history of CNS disease (either CNS lymphoma or leukaemic meningitis) 12. History of Richter transformation
- •13. Allergy to rat proteins
- •14. Concomitant malignancies except adequately treated localised non-melanoma skin cancer and cancers that have been in remission for at least 5 years
- •15. Major surgery within 28 days prior to registration
- •16. Any serious underlying medical or psychological conditions, which could impair the ability of the patient to participate in the trial or compromise ability to give informed consent
- •17. Treatment within a clinical trial within 30 days prior to trial entry
- •18. Adult patient under tutelage (not competent to sign informed consent)
- •19. Pregnant or lactating women
- •20. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom
- •21. Women taking the oral contraceptive pill within 4 weeks of study registration owing to an increased risk of thromboembolism
研究者
相似试验
终止
2 期
Daratumumab, Azacitidine, and Dexamethasone for Treatment of Patients With Recurrent or Refractory Multiple Myeloma Previously Treated With DaratumumabRecurrent Plasma Cell MyelomaRefractory Plasma Cell MyelomaNCT04407442University of California, San Francisco5
已完成
2 期
Rituximab and DexaBEAM as Salvage Therapy for Relapsed LymphomaRelapsed Non-Hodgkin-LymphomaNCT02099292Georg Hess, MD103
进行中（未招募）
1 期
Phase II trial of ofatumumab, dexamethasone and lenalidomide for high-risk CLL (NCRI CLL210) - CLL210 (OfaDexRev)Chronic lymphocytic leukaemia / Small Lymphocytic LymphomaMedDRA version: 18.0 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 100000004864MedDRA version: 18.0 Level: LLT Classification code 10041152 Term: Small lymphocytic lymphoma, consistent with CLL (Working Formulation) System Organ Class: 100000004864EUCTR2010-019575-29-GBniversity of Liverpool64
已完成
2 期
Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin LymphomaContiguous Stage II Grade 1 Follicular LymphomaContiguous Stage II Grade 2 Follicular LymphomaContiguous Stage II Marginal Zone LymphomaCutaneous B-cell Non-Hodgkin LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Marginal Zone LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Marginal Zone LymphomaSplenic Marginal Zone LymphomaStage I Grade 1 Follicular LymphomaStage I Grade 2 Follicular LymphomaStage I Marginal Zone LymphomaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Marginal Zone LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Marginal Zone LymphomaWaldenstrom MacroglobulinemiaNCT00244855Fred Hutchinson Cancer Center32
已完成
2 期
Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological MalignanciesAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Nasal Type Extranodal NK/T-cell LymphomaAngioimmunoblastic T-cell LymphomaChildhood Burkitt LymphomaChildhood Chronic Myelogenous LeukemiaChildhood Diffuse Large Cell LymphomaChildhood Immunoblastic Large Cell LymphomaChildhood Nasal Type Extranodal NK/T-cell LymphomaChronic Phase Chronic Myelogenous LeukemiaContiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaContiguous Stage II Grade 1 Follicular LymphomaContiguous Stage II Grade 2 Follicular LymphomaContiguous Stage II Marginal Zone LymphomaContiguous Stage II Small Lymphocytic LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiableNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Marginal Zone LymphomaNoncontiguous Stage II Small Lymphocytic LymphomaPeripheral T-cell LymphomaPreviously Treated Myelodysplastic SyndromesProgressive Hairy Cell Leukemia, Initial TreatmentRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Anaplastic Large Cell LymphomaRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaRecurrent/Refractory Childhood Hodgkin LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRefractory Multiple MyelomaRelapsing Chronic Myelogenous LeukemiaSplenic Marginal Zone LymphomaStage I Adult Diffuse Small Cleaved Cell LymphomaStage I Childhood Anaplastic Large Cell LymphomaStage I Childhood Large Cell LymphomaStage I Cutaneous T-cell Non-Hodgkin LymphomaStage I Grade 1 Follicular LymphomaStage I Grade 2 Follicular LymphomaStage I Mantle Cell LymphomaStage I Marginal Zone LymphomaStage I Mycosis Fungoides/Sezary SyndromeStage I Small Lymphocytic LymphomaStage II Childhood Anaplastic Large Cell LymphomaStage II Childhood Large Cell LymphomaStage II Cutaneous T-cell Non-Hodgkin LymphomaStage II Mycosis Fungoides/Sezary SyndromeStage III Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Small Cleaved Cell LymphomaStage III Childhood Anaplastic Large Cell LymphomaStage III Childhood Large Cell LymphomaStage III Cutaneous T-cell Non-Hodgkin LymphomaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Mantle Cell LymphomaStage III Marginal Zone LymphomaStage III Mycosis Fungoides/Sezary SyndromeStage III Small Lymphocytic LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Childhood Anaplastic Large Cell LymphomaStage IV Childhood Large Cell LymphomaStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Mycosis Fungoides/Sezary SyndromeStage IV Small Lymphocytic LymphomaT-cell Large Granular Lymphocyte LeukemiaWaldenström MacroglobulinemiaAnaplastic Large Cell LymphomaNCT00040846Fred Hutchinson Cancer Center60