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

ConditionT Cell Lymphoma

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age20-85

SponsorWon Seog Kim

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

ACHOP
Drug
1. Phase I Azacitidine D-2\~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 escalated stepwise to levels 2, 3, and then 4. Azacitidine combined with CHOP regimen every 3 weeks as below: * Level 1 - Azacitidine 50mg/m2 D-2, -1, 1 * Level 2 - Azacitidine 75mg/m2 D-2, -1, 1 * Level 3 - Azacitidine 100mg/m2 D-2, -1, 1 * Level 4 - Azacitidine 125mg/m2 D-2, -1, 1 Azacitidine at each level will be combined with the corresponding CHOP regimen as follows: * Cyclophosphamide 750mg/m2 d1 * Doxorubicin 50 mg/m2 d1 * Vincristine 1.4 mg/m2 (Max: 2 mg) d1 * Prednisolone 100mg PO d1-5 2. Phase II * Azacitidine determined dose daily for D-2, -1, 1 * CHOP (Cyclophosphamide 750mg/m2 d1, Doxorubicin 50 mg/m2 d1, Vincristine 1.4 mg/m2 (Max: 2 mg) d1, Prednisolone 100mg PO d1-5), 6 cycles in total

Treatment groups

41 Participants

are divided into 1 treatment group

Group A: Arm ACHOPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

complete response rate

Time frame

Up to 72 months

Secondary outcomes

overall response rate

Time frame

Up to 72 months

overall survival

The time until defined by date of all-cause mortality from the date of IP Administration.

Time frame

Up to 72 months.

Adverse events

Time frame

from the day 1 of the clinical trial to 28 days after last drug administration

progression-free survival

The time until defined by date of all-cause mortality from the date of Investigational Product Administration.

Time frame

Up to 72 months.

Other outcomes

Predictive biomarkers study

analysis of blood sampling before and after the clinical trial

Time frame

Up to 72 months.

establishment of treatment response prediction model

genomic analysis of tumor tissue at diagnosis

Time frame

Up to 72 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Won Seog Kim

Lead sponsor

Samsung Medical Center

Sponsor institution

Source ClinicalTrials.gov

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