T Cell LymphomaPhase 1/2NCT05230680
Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype (ACANTUS)
A Phase 1/2 study testing ACHOP in people with T Cell Lymphoma, run by Won Seog Kim at 1 site in South Korea.
Trial 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 mg/m2 d1 Vincristine 1.4 mg/m2 (Max: 2 mg) d1 Prednisolone 100mg PO d1-5 Maintenance treatment (every 4 weeks, total 12… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- T Cell Lymphoma
- What is being tested?
- ACHOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2022to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Seoul, 06351
Kim Wonseog, phD, 82-10-9933-5823, wonseog.kim@samsung.com
shin hyunjung, 82-2-3410-6763, hjds.shin@samsung.com
About this study
Official title: Multicenter, Open Label, Phase I/II of Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype
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
Read the detailed description
- 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 escalated stepwise to levels 2, 3, and then 4. Subjects will receive intravenous 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
- Phase II
- Azacitidine determined dose daily for D-2, -1, 1, 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)
- Use prophylactic trimethoprim-sulfamethoxazole 1T from the day of study drug administration to 21 days after the last dose of study treatment
- Administer Peg-GCSF on study d2.
- After Cycle 2, the study treatment can be administered if the ANC has been restored to ≥1,500/μL and platelets to ≥75,000/μL, and non-hematological toxicities that occurred in the previous cycle, except alopecia, have resolved to Grade 1 or less on d1 of each cycle.
- If these hematological and non-hematological toxicities are not resolved, the clinical trial can be delayed for up to 21 days.
- Consolidation therapy
- After completing the planned first-line therapy in the clinical trial, the following consolidation therapy should be performed, regardless of the azacitidine dose level.
- Azacitidine 75mg/m2 d1-5 (every 4 weeks, total 12 cycles)
- Conditions
- T Cell Lymphoma
- Being tested
- ACHOP
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACHOPDrug
- 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
- 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
| Study group | Role | What they receive |
|---|---|---|
| Arm ACHOP | Experimental | 1. Phase I Azacitidine D1-3 + CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone)
* 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
2. Phase II
* Azacitidine D-2, -1, 1 + CHOP(Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone)
* 6 cycles in total Receives: Drug: ACHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate
Measured: Up to 72 months
Secondary outcomes (5)
overall response rate
Measured: Up to 72 months
overall survival
The time until defined by date of all-cause mortality from the date of IP Administration.
Measured: Up to 72 months.
Adverse events
Measured: 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.
Measured: Up to 72 months.
event-free survival
As the period from enrollment to disease progression/recurrence, treatment for other lymphomas, or death.
Measured: Up to 72 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Won Seog Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Won Seog Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230680
- Sponsor's protocol ID
- 2021-09-142
- Status last verified
- Oct 2023
- First submitted
- 11 Jan 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open Label, Phase I/II of Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype
- ClinicalTrials.gov ID
- NCT05230680
- Acronym / sponsor ID
- 2021-09-142
- Conditions
- T Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Won Seog KimUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- 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 escalated stepwise to levels 2, 3, and then 4. Subjects will receive intravenous 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
- Phase II
- Azacitidine determined dose daily for D-2, -1, 1, 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)
- Use prophylactic trimethoprim-sulfamethoxazole 1T from the day of study drug administration to 21 days after the last dose of study treatment
- Administer Peg-GCSF on study d2.
- After Cycle 2, the study treatment can be administered if the ANC has been restored to ≥1,500/μL and platelets to ≥75,000/μL, and non-hematological toxicities that occurred in the previous cycle, except alopecia, have resolved to Grade 1 or less on d1 of each cycle.
- If these hematological and non-hematological toxicities are not resolved, the clinical trial can be delayed for up to 21 days.
- Consolidation therapy
- After completing the planned first-line therapy in the clinical trial, the following consolidation therapy should be performed, regardless of the azacitidine dose level.
- Azacitidine 75mg/m2 d1-5 (every 4 weeks, total 12 cycles)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm ACHOP | Experimental | Drug: ACHOP1. Phase I Azacitidine D1-3 + CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone) * 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 2. Phase II * Azacitidine D-2, -1, 1 + CHOP(Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone) * 6 cycles in total |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACHOP1. 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 | Drug | Arm ACHOP |
Primary outcome
complete response rate
Time frame: Up to 72 months
5 secondary outcomes
overall response rate
Time frame: Up to 72 months
overall survival
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
Time frame: Up to 72 months.
event-free survival
Time frame: Up to 72 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACHOP in people with T Cell Lymphoma, run by Won Seog Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kim wonseog, phD (82-10-9933-5823, wonseog.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response rate (time frame: Up to 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.