Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype (ACANTUS)

Launched by WON SEOG KIM · Feb 3, 2022

Keywords

ClinConnect Summary

The ACANTUS clinical trial is investigating a new treatment for patients with a specific type of T-cell lymphoma known as nodal T-cell lymphoma with T-follicular helper phenotype. This phase 1 trial will test a combination of medications, including Azacitidine and chemotherapy drugs, to see how well they work together. Participants will receive treatment every three weeks for a total of six cycles, followed by maintenance treatment every four weeks for 12 cycles. The trial is currently recruiting patients aged 20 to 85 who have not previously received treatment for this type of lymphoma and meet certain health criteria.

Eligible participants will undergo careful screening to ensure they have the necessary health conditions to safely receive the treatment. This includes having adequate heart, kidney, and liver function. Throughout the trial, participants will be closely monitored for their health and response to the treatment. It’s important for potential participants to understand that they may have to follow specific guidelines regarding contraception during and after the study period. Overall, this trial aims to explore a promising treatment option for a challenging type of cancer, and participants will play a crucial role in this important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. 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
• • 2. 20 to 85 years of age at diagnosis
• • 3. ECOG performance status 0-2
• • 4. Cardiac function suitable for chemotherapy: LVEF ≥45% on echocardiography or MUGA
• • 5. Appropriate renal function: Serum Cr ≤2.0mg/dL or eGFR ≥ 30mL/min according to the Cockroft-Gault formula
• • 6. 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)
• • 7. 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)
• • 8. Written informed consent to participate in the study
• • 9. Capable of following the study visit schedule and other requirements in the protocol
• • 10. For women of childbearing potential, a negative pregnancy test
• • 11. 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.
• • 12. Life expectancy ≥90 days (3 months)
• • 13. 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 Criteria:
• • 1. Other subtypes of non-Hodgkin's lymphoma
• • 2. History of chemotherapy for Hodgkin's or other non-Hodgkin's lymphoma in the last 5 years
• • 3. 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)
• • 4. Uncontrolled hepatitis B (with the exception of asymptomatic HBsAg-positive or anti-HBcAb-positive cases receiving antiviral prophylaxis such as entecavir or tenofovir)
• • 5. History of chronic hepatitis C (with the exception of HCV IgG positive with a negative HCV-RNA quantification)
• • 6. History of human immunodeficiency virus (HIV) infection
• • 7. Congestive heart failure (NYHA class ≥3)
• • 8. Acute coronary syndrome (new-onset unstable angina or myocardial infarction) or ventricular tachycardia within 6 months prior to study entry
• • 9. History of major neurological or psychiatric illness, including dementia or epilepsy
• • 10. Severe chronic obstructive pulmonary disease with hypoxemia
• • 11. Cerebrovascular disease within 3 months prior to study entry (including transient cerebral ischemia)
• • 12. Unresolved wounds, ulcers, or bone fractures
• • 13. Uncontrolled active infections (viral, bacterial, or fungal infections)
• • 14. Concurrent use of other experimental drugs under investigation
• • 15. Known hypersensitivity to the investigational drugs
• • 16. History of major surgery or serious trauma within 21 days prior to study treatment. Open biopsy within 7 days prior to study treatment
• • 17. 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
• • 18. Pregnant or breastfeeding women or women of childbearing potential and men who are not willing to use appropriate methods of contraception during the study
• • 19. Previously treated for T-cell lymphoma with immunotherapy or chemotherapy, except for short-term corticosteroids (for less than 8 days) prior to selection
• • 20. Prior radiotherapy, except for those localized to a single lymph node
• • 21. Central nervous system involvement
• • 22. Contraindication to any of the drugs included in the chemotherapy
• • 23. History of administration of doxorubicin at \>200 mg/m²