Status:
RECRUITING
Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype (ACANTUS)
Lead Sponsor:
Won Seog Kim
Conditions:
T Cell Lymphoma
Eligibility:
All Genders
20-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
1. Phase I Azacitidine will be administered intravenously from d-2 to d1, starting from dose level 1. Based on the BOIN design described above, if no DLT is identified in level 1, the dose will be esc...
Eligibility Criteria
Inclusion
- Treatment-naïve patients with newly diagnosed nodal T-cell lymphoma with T-follicular helper (TFH) phenotype as determined by the following 2016 WHO diagnostic criteria:
- Angioimmunoblastic T-cell lymphoma
- Follicular helper T-cell lymphoma
- Peripheral T-cell lymphoma with follicular helper T-cell type
- 20 to 85 years of age at diagnosis
- ECOG performance status 0-2
- Cardiac function suitable for chemotherapy: LVEF ≥45% on echocardiography or MUGA
- Appropriate renal function: Serum Cr ≤2.0mg/dL or eGFR ≥ 30mL/min according to the Cockroft-Gault formula
- Appropriate hepatic function: ALT ≤2.5x upper limit of normal (ULN) (or ≤5x ULN in the presence of liver involvement), total bilirubin ≤2x ULN (or ≤3x ULN in the presence of liver involvement)
- Appropriate hematologic findings: absolute neutrophil count (ANC) ≥1,500/μL, platelets ≥100,000/μL (or ANC ≥500/μL and platelets ≥50,000/ μL in the presence of bone marrow involvement)
- Written informed consent to participate in the study
- Capable of following the study visit schedule and other requirements in the protocol
- For women of childbearing potential, a negative pregnancy test
- Women of childbearing potential must use an effective method of contraception (i.e., hormonal contraception, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study period and for 3 months afterward. Men are to use an effective method of contraception during the study period and for 3 months afterward.
- Life expectancy ≥90 days (3 months)
- Hepatitis B or C infection: Hepatitis B carriers and subjects with inactive hepatitis C infection (normal levels of aminotransferases) are eligible if they take prophylactic antiviral drugs
Exclusion
- Other subtypes of non-Hodgkin's lymphoma
- History of chemotherapy for Hodgkin's or other non-Hodgkin's lymphoma in the last 5 years
- History of active cancer diagnosed within the last 3 years (with the exception of completely resected non-melanoma skin cancer, papillary thyroid cancer, carcinoma in situ of cervical cancer or breast cancer, and localized prostate cancer)
- Uncontrolled hepatitis B (with the exception of asymptomatic HBsAg-positive or anti-HBcAb-positive cases receiving antiviral prophylaxis such as entecavir or tenofovir)
- History of chronic hepatitis C (with the exception of HCV IgG positive with a negative HCV-RNA quantification)
- History of human immunodeficiency virus (HIV) infection
- Congestive heart failure (NYHA class ≥3)
- Acute coronary syndrome (new-onset unstable angina or myocardial infarction) or ventricular tachycardia within 6 months prior to study entry
- History of major neurological or psychiatric illness, including dementia or epilepsy
- Severe chronic obstructive pulmonary disease with hypoxemia
- Cerebrovascular disease within 3 months prior to study entry (including transient cerebral ischemia)
- Unresolved wounds, ulcers, or bone fractures
- Uncontrolled active infections (viral, bacterial, or fungal infections)
- Concurrent use of other experimental drugs under investigation
- Known hypersensitivity to the investigational drugs
- History of major surgery or serious trauma within 21 days prior to study treatment. Open biopsy within 7 days prior to study treatment
- Male subjects who had not undergone a vasectomy and have a partner who plans to become pregnant or are unable to use a medically acceptable method of contraception (partner's sterilization or intrauterine device placement, or barrier method combined with diaphragm or condom) during the subject's participation in the study
- Pregnant or breastfeeding women or women of childbearing potential and men who are not willing to use appropriate methods of contraception during the study
- Previously treated for T-cell lymphoma with immunotherapy or chemotherapy, except for short-term corticosteroids (for less than 8 days) prior to selection
- Prior radiotherapy, except for those localized to a single lymph node
- Central nervous system involvement
- Contraindication to any of the drugs included in the chemotherapy
- History of administration of doxorubicin at \>200 mg/m²
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT05230680
Start Date
July 1 2022
End Date
December 31 2026
Last Update
October 23 2023
Active Locations (1)
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1
81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Seoul, South Korea, 06351