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New treatment option for T Cell Lymphoma
Official title Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype (ACANTUS)
ClinicalTrials.gov ID: NCT05230680
What this study is testing
What is ACHOP?
ACHOP is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for t cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 85
You may be able to join if
- Treatment-naïve patients with newly diagnosed nodal T-cell lymphoma with T-follicular helper (TFH) phenotype as determined by the following 2016 WHO...
- 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
You likely can't join if
- 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...
- Uncontrolled hepatitis B (with the exception of asymptomatic HBsAg-positive or anti-HBcAb-positive cases receiving antiviral prophylaxis such as...
- 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
See the full eligibility criteria
- 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...
- Life expectancy ≥90 days (3 months)
- Hepatitis B or C infection: Hepatitis B carriers and people with inactive hepatitis C infection (normal levels of aminotransferases) are eligible if they take prophylactic antiviral drugs
- 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...
- 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 people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.