CTRI/2016/03/006718进行中（未招募）2 期
A multicenter, randomised, open-label, three-parallel groups, phase 2-3 study to evaluate the efficacy and safety of AB1010 with dexamethasone, gemcitabine with dexamethasone and the combination of AB1010, gemcitabine anddexamethasone in patients with relapsed or refractory peripheral T-cell lymphoma.
AB Science0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
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
入选标准
- •1. Patient with histologically/cytologically confirmed peripheral T-cell lymphoma (PTCL), using the World Health
- •Organisation (WHO) disease classification 2008:
- •- Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
- •- Angioimmunoblastic T-cell lymphoma
- •- Anaplastic large cell lymphoma ALK+
- •- Anaplastic large cell lymphoma ALK-
- •- Peripheral T-cell lymphoma - NOS (not otherwise specified)
- •- Extranodal Natural Killer (NK)/T-cell lymphoma
- •- Enteropathy-associated T-cell lymphoma
- •- Hepatosplenic T-cell lymphoma
- •- Subcutaneous panniculitis T-cell lymphoma
- •- Transformed mycosis fungoides
- •2. Patient with documented progression of disease after at least 1 previous chemotherapy cycle
- •3. Patient with minimum 1 bidimensionally measurable disease (more than 1.5 cm) according the Cheson criteria
- •4. Patient having Ann Arbor stage IIâ??IV
- •5. Patient with ECOG Performance Status < 2
- •6. Patients with adequate organ function
- •- Absolute neutrophils count (ANC) >= 1.5 x 109/L, or >= 1 x 109/L in case of medullary involvement
- •- Haemoglobin >= 10 g/dL
- •- Platelets (PTL) >= 75 x 109/L
- •- AST/ALT <= 3x ULN (<= 5 x ULN in case of liver metastases)
- •- Gamma GT <= 2.5 x ULN (<= 5 x ULN in case of liver metastases)
- •- Bilirubin <= 1.5x ULN (<= 3xULN in case of liver metastases)
- •- Normal Creatinine or if abnormal creatinine, creatinine clearance >= 50 mL/min (Cockcroft and Gault formula)
- •- Albumin > 1 x LLN
- •- Proteinuria < 30 mg/mL (1+) on the dipstick. If proteinuria is >= 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
- •7. Patient with life expectancy > 3 months
- •8. Man or woman, age >= 18 years
- •9. Body mass index > 18 and body weight > 40 kg
- •10. Man and woman of childbearing potential (entering the study after a menstrual period and who have a negative
- •pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
- •11. Patient able and willing to comply with study procedures as per protocol.
- •12. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms
- •of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment.
- •13. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any
- •protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively
- •impaired or questionably impaired in such a way that the ability of the patient to give informed consent is
- •questionable, the designated legal guardian must sign the informed consent.
排除标准
- •1. Patient with:
- •- T-cell prolymphocytic leukemia
- •- T-cell large granular lymphocytic leukemia
- •- Mycosis fungoides, other than transformed mycosis fungoides
- •- Sezary syndrome
- •- Primary cutaneous CD30+ T-cell lymphoproliferative disorders
- •2. Patient with central nervous involvement of lymphoma
- •3. Patient with previous allogeneic stem cell transplantation
- •4. Patient who relapsed less than three months after an autologous stem cell transplantation
- •5. Patient presenting with cardiac disorders defined by at least one of the following conditions:
- •- Patient with recent cardiac history (within 6 months) of:
- •- Acute coronary syndrome
- •- Acute heart failure (class III or IV of the NYHA classification)
- •- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular
- •fibrillation, resuscitated sudden death)
- •- Patient with cardiac failure class III or IV of the NYHA classification
- •- Patient with severe conduction disorders which are not prevented by permanent pacing (atrioventricular
- •block 2 and 3, sino-atrial block)
- •- Syncope without known aetiology within 3 months
- •- Uncontrolled severe hypertension, according to the judgement of the investigator, or
- •symptomatic hypertension
- •6. Patient with clinically uncontrolled infectious diseases and patient with Human
- •Immunodeficiency Virus infection and/or hepatitis B or C infection
- •7. Patient with a history of any other malignancy within the 5 years prior to study treatment, except
- •carcinoma in situ of the cervix or basal cell carcinoma of the skin
- •8. Pregnant or nursing woman
- •9. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol
- •beverage consumption that would interfere with the ability to comply with the study protocol, or
- •current or past psychiatric disease that might interfere with the ability to comply with the study
- •protocol or give informed consent
- •10. Patient with known hypersensitivity to gemcitabine and/or excipients
研究者
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