Efficacy and safety of AB1010 with dexamethasone, gemcitabine in patients with relapsed or refractory peripheral T-cell lymphoma.
- Conditions
- Health Condition 1: null- patients with relapsed or refractoryperipheral T-cell lymphoma
- Registration Number
- CTRI/2016/03/006718
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS)Timepoint: Till death or lost to followup
- Secondary Outcome Measures
Name Time Method Overall Progression Free Survival (PFS) ratesTimepoint: W12, W24 and then every 24 weeks;Survival ratesTimepoint: W12, W24 and then every 24 weeks;TTP rateTimepoint: W12, W24 and then every 24 weeks