Actively Recruiting
Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype (ACANTUS)
Led by Won Seog Kim · Updated on 2023-10-23
41
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Induction treatment (every 3 weeks, total 6 cycles) * Azacitidine D-2, -1, 1 (level 1: 50mg/m2, level 2: 75mg/m2, level 3: 100mg/m2, level 4: 125mg/m2) * Cyclophosphamide 750mg/m2 d1 * Doxorubicin 50 mg/m2 d1 * Vincristine 1.4 mg/m2 (Max: 2 mg) d1 * Prednisolone 100mg PO d1-5 Maintenance treatment (every 4 weeks, total 12 cycles) * Azacitidine 75mg/m2 d1-5
CONDITIONS
Official Title
Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype (ACANTUS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Treatment-naive patients with newly diagnosed nodal T-cell lymphoma with T-follicular helper phenotype as defined by 2016 WHO criteria
- Age between 20 and 85 years at diagnosis
- ECOG performance status of 0 to 2
- Cardiac function with left ventricular ejection fraction of at least 45% on echocardiography or MUGA
- Kidney function with serum creatinine 2.0 mg/dL or less or estimated glomerular filtration rate of 30 mL/min or greater
- Liver function with ALT less than or equal to 2.5 times the upper limit of normal (or 5 times if liver involvement), total bilirubin less than or equal to 2 times the upper limit of normal (or 3 times if liver involvement)
- Blood counts with absolute neutrophil count of at least 1,500/µL and platelets at least 100,000/µL (or ANC at least 500/µL and platelets at least 50,000/µL if bone marrow involved)
- Written informed consent
- Ability to follow study visit schedule and protocol requirements
- Negative pregnancy test for women of childbearing potential
- Use of effective contraception for women of childbearing potential and men during the study and for 3 months after
- Life expectancy of at least 90 days
- Hepatitis B or C carriers eligible if taking antiviral prophylaxis
You will not qualify if you...
- Other subtypes of non-Hodgkin's lymphoma
- Chemotherapy for Hodgkin's or non-Hodgkin's lymphoma within the past 5 years
- Active cancer diagnosed within the last 3 years except certain skin, thyroid, cervical, breast, or prostate cancers
- Uncontrolled hepatitis B except asymptomatic cases on antiviral prophylaxis
- Chronic hepatitis C except HCV IgG positive with negative HCV-RNA
- History of HIV infection
- Congestive heart failure NYHA class 3 or above
- Acute coronary syndrome or ventricular tachycardia within 6 months before study
- Major neurological or psychiatric illness including dementia or epilepsy
- Severe chronic obstructive pulmonary disease with low oxygen
- Cerebrovascular disease within 3 months before study
- Unhealed wounds, ulcers, or bone fractures
- Uncontrolled active infections
- Use of other experimental drugs
- Known allergy to study drugs
- Major surgery or serious trauma within 21 days before treatment
- Open biopsy within 7 days before treatment
- Male without vasectomy and partner planning pregnancy or unable to use contraception
- Pregnant or breastfeeding women or those unwilling to use contraception
- Prior treatment for T-cell lymphoma except short-term corticosteroids
- Prior radiotherapy except localized to one lymph node
- Central nervous system involvement
- Contraindication to any chemotherapy drugs
- History of doxorubicin dose over 200 mg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Seoul, South Korea, 06351
Actively Recruiting
Research Team
K
kim wonseog, phD
CONTACT
S
shin hyunjung
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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