Peripheral T-cell Lymphoma (PTCL)Phase 2NCT06941688
Evaluating the Effectiveness of Decitabine With Gemcitabine, Oxaliplatin for Relapsed/Refractory Peripheral T-cell Lymphoma
A Phase 2 study testing Decitabine with GemOx and GemOx in people with Peripheral T-cell Lymphoma (PTCL), run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To establish an optimal therapeutic strategy for patients with peripheral T-cell lymphoma (PTCL) who have relapsed after first-line chemotherapy or are refractory to initial treatment, we designed a phase II trial to evaluate the efficacy of a multidrug combination regimen comprising decitabine, gemcitabine, and… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma (PTCL)
- What is being tested?
- Decitabine with GemOx and GemOx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2020to 30 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria to be considered eligible.
- Patients with histologically confirmed peripheral T-cell lymphoma (PTCL) who have either relapsed after first-line chemotherapy or experienced disease progression due to refractory disease, and who are deemed eligible for further chemotherapy.
- Age ≥ 19 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Adequate bone marrow function, defined as:
- White blood cell count ≥ 3,000/μL
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- Absolute neutrophil count ≥ 2,000/μL
- Platelet count ≥ 75,000/μL
- Hemoglobin ≥ 8.0 g/dL Note: Transfusions within 1 week prior to screening are not permitted.
- Adequate renal function, defined as serum creatinine ≤ 1.5 × upper limit of normal (ULN).
- Adequate hepatic function, defined as:
- Serum total bilirubin ≤ 1.5 × ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases) Note: Patients with hepatic dysfunction due to underlying disease may be enrolled at the investigator's discretion.
- Presence of measurable disease.
- Ability to understand and provide written informed consent.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Female patients of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) test within 3 weeks prior to treatment, and must agree to use effective contraception (e.g., barrier methods) from 4 weeks prior to treatment initiation through the study duration.
Who cannot join
- Patients will be deemed ineligible if they meet any of the exclusion criteria listed below.
- Diagnosis of a malignancy other than lymphoma within the past 3 years.
- More than two prior lines of chemotherapy for lymphoma. Note: Autologous stem cell transplantation is considered part of one treatment regimen.
- Evidence of uncontrolled central nervous system involvement.
- History of solid organ or allogeneic stem cell transplantation.
- Uncontrolled seizures or significant psychiatric disorders.
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- Pregnancy or breastfeeding.
- Any other serious illness or medical condition deemed inappropriate by the investigator.
- Presence of grade ≥2 peripheral neuropathy.
- Prior treatment with gemcitabine for lymphoma.
- History of HIV infection or active, uncontrolled bacterial, viral, or fungal infections.
- Surgery within 14 days prior to enrollment, or failure to recover from surgical complications.
- Patients currently receiving thoracic radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Multicentre, Randomized Study of Decitabine Plus GemOx Versus GemOx for Relapsed/Refractory Peripheral T-cell Lymphoma
To establish an optimal therapeutic strategy for patients with peripheral T-cell lymphoma (PTCL) who have relapsed after first-line chemotherapy or are refractory to initial treatment, we designed a phase II trial to evaluate the efficacy of a multidrug combination regimen comprising decitabine, gemcitabine, and oxaliplatin as a second-line or later treatment. This clinical trial is based on a review of existing literature, which supports the rationale for using this three-drug combination.
- Conditions
- Peripheral T-cell Lymphoma (PTCL)
- Being tested
- Decitabine with GemOx, GemOx
- Keywords
- PTCL, Decitabine, GemOx, Randomized Phase II trial
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decitabine with GemOxDrug
Each treatment cycle consists of 3 weeks, and a total of 6 cycles will be administered. The drugs will be administered sequentially in the following order: decitabine, gemcitabine, and oxaliplatin. Decitabine will be administered at a dose of 7.5 mg/m² on days 1 to 5; gemcitabine at 1000 mg/m² on days 1 and 8; and oxaliplatin at 100 mg/m² on day 1 of each cycle.
GemOxDrug
Each treatment cycle spans 3 weeks, with a total of 6 cycles planned. Gemcitabine will be administered at a dose of 1000 mg/m² on days 1 and 8, and oxaliplatin at 100 mg/m² on day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Decatabine + GemOx (gemcitabine, oxaliplatin) | Experimental | Not described Receives: Drug: Decitabine with GemOx |
| GemOx (gemcitabine, oxaliplatin) | Active comparator | Not described Receives: Drug: GemOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The objective response rate (ORR) is defined as the proportion of patients who achieve either a complete response (CR) or a partial response (PR) to treatment, as assessed by Lugano criteria.
Measured: From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
Secondary outcomes (4)
Complete response (CR) rate
Measured: From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
Time to response (TTR)
Measured: From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
Progression-free survival (PFS)
Measured: From cycle 1 day 1 to study completion, an average of 2 years.
Overall survival (OS)
Measured: From cycle 1 day 1 to study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start13 Nov 2020
- Primary completion13 Aug 2024
- Study completion30 Dec 2024
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell Lymphoma (PTCL)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YOUNGIL KOH, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941688
- Sponsor's protocol ID
- 1904-052-1027
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicentre, Randomized Study of Decitabine Plus GemOx Versus GemOx for Relapsed/Refractory Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06941688
- Acronym / sponsor ID
- 1904-052-1027
- Conditions
- Peripheral T-cell Lymphoma (PTCL)
- Keywords
- PTCL, Decitabine, GemOx, Randomized Phase II trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 24 Apr 2025 (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.
To establish an optimal therapeutic strategy for patients with peripheral T-cell lymphoma (PTCL) who have relapsed after first-line chemotherapy or are refractory to initial treatment, we designed a phase II trial to evaluate the efficacy of a multidrug combination regimen comprising decitabine, gemcitabine, and oxaliplatin as a second-line or later treatment. This clinical trial is based on a review of existing literature, which supports the rationale for using this three-drug combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decatabine + GemOx (gemcitabine, oxaliplatin) | Experimental | Drug: Decitabine with GemOx |
| GemOx (gemcitabine, oxaliplatin) | Active comparator | Drug: GemOx |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must meet all of the following criteria to be considered eligible.
Key exclusion criteria (13 listed)
- Patients will be deemed ineligible if they meet any of the exclusion criteria listed below.
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 |
|---|---|---|
| Decitabine with GemOxEach treatment cycle consists of 3 weeks, and a total of 6 cycles will be administered. The drugs will be administered sequentially in the following order: decitabine, gemcitabine, and oxaliplatin. Decitabine will be administered at a dose of 7.5 mg/m² on days 1 to 5; gemcitabine at 1000 mg/m² on days 1 and 8; and oxaliplatin at 100 mg/m² on day 1 of each cycle. | Drug | Decatabine + GemOx (gemcitabine, oxaliplatin) |
| GemOxEach treatment cycle spans 3 weeks, with a total of 6 cycles planned. Gemcitabine will be administered at a dose of 1000 mg/m² on days 1 and 8, and oxaliplatin at 100 mg/m² on day 1 of each cycle. | Drug | GemOx (gemcitabine, oxaliplatin) |
Primary outcome
Objective response rate
Time frame: From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
The objective response rate (ORR) is defined as the proportion of patients who achieve either a complete response (CR) or a partial response (PR) to treatment, as assessed by Lugano criteria.
4 secondary outcomes
Complete response (CR) rate
Time frame: From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
Time to response (TTR)
Time frame: From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
Progression-free survival (PFS)
Time frame: From cycle 1 day 1 to study completion, an average of 2 years.
Overall survival (OS)
Time frame: From cycle 1 day 1 to study completion, an average of 2 years.
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decitabine with GemOx and GemOx in people with Peripheral T-cell Lymphoma (PTCL), run by Seoul National University Hospital 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 17 inclusion and 13 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: stopped early, as of the sponsor's last update on 24 Apr 2025. 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 phase mean?
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?
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)). 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 24 Apr 2025.