Peripheral T-cell LymphomaPhase 3NCT03553537
Efficacy and Safety of Decitabine Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
A Phase 3 study testing Decitabine, Cyclophosphamide and Doxorubicin in people with Peripheral T-cell Lymphoma, run by Southwest Hospital, China.
Trial summary
Primary objective of the study is to compare the efficacy and safety of decitabine plus CHOP (D-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Decitabine, Cyclophosphamide and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Jul 2021
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, anapestic large cell lymphoma, enteropathy-associated T cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype and Follicular T-cell lymphoma).
- Males and females of 18 years of age to 80 years of age.
- Patients have not received anti-tumor therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Fit chemotherapy indications and basic requirements, including no obvious abnormal function of heart, liver, lung and kidney: creatine ≤2.0×ULN, total bilirubin ≤2.0mg/dl, transaminases≤3×ULN.
- Normal peripheral hemogram: ANC≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^12/L.
Show all 11Show fewer
- None of other serious disease conflict with the therapeutic regimen.
- None of other malignant tumor.
- Pregnancy test of women at reproductive age must be negative.
- Estimated survival time ≥ 3 months with good compliance.
- Voluntary participation, cooperate with the experimental observation, and sign a written informed consent.
Who cannot join
- Patients with the following PTCL subtypes are excluded; extranodal NNK/T-cell lymphoma, T-prolymphocytic leukemia, T large granular lymphocytic leukemia, chronic lymphoproliferative disorder of NK cells, aggressive natural killer-cell leukemia, adult T-cell leukemia/ lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous T cell lymphoma, breast implant-associated anaplastic large-cell lymphoma.
- Transformed lymphoma.
- Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies.
- Already initiated lymphoma therapy (exept for the prephase treatment specified for this study).
- Patients with primary central nervous system lymphoma or lymphoma involving central nervous system.
- Patients who have central nervous system or meninges involvements.
Show all 16Show fewer
- Candidate for hematopoietic stem cell transplantation.
- Known hypersensitivity to medications to be used.
- Hemogram abnormality: ANC<1.5×10^9/L; or HGB<90 g/L; or PLT<100×10^9/L.
- Known hepatic and renal insufficiency (creatine>2.0×ULN, total bilirubin>2.0 mg/dl，transaminases>3.0×ULN).
- Patients with decompensated heart failure; or with dilated cardiomyopathy; or with coronary heart disease of non-corresponding ST-segment in ECG diagnosis; or with myocardial infarction within 6 months.
- Patients with serious uncontroled acute infection need to be treated with antibody therapies, or antiviral therapies; or serious accompanying disorder or impaired organ function.
- Know HIV-positivity; or HbsAg positivity; or HCV-Ab positivity.
- Pregnancy or lactation period.
- Patients who participated in other clinical trials within 3 months.
- The researchers considered that patients should not be in this trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Multi-center Randomized Study to Compare Efficacy and Safety of Decitabine Plus CHOP (D-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Primary objective of the study is to compare the efficacy and safety of decitabine plus CHOP (D-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL).
Read the detailed description
This is a randomized, multi-center, open-label study to compare efficacy and safety of D-CHOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles or decitabine plus CHOP (D-CHOP) administered in 4 week cycles for 6 cycles. In the D-CHOP arm, decitabine will be administered at a dose of 10 mg/m² IV on day 1-5 every 3 weeks. This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary withdrawal.Adverse event of every treatment cycle will be recorded.Therapy efficacy will be evaluated after finishing 3 cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 2 years from the last patient randomized.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Decitabine, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
- Keywords
- Peripheral T-cell Lymphoma, decitabine
- 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.
DecitabineDrug
Also called 5-aza-2'-deoxycytidine
10mg/m² iv on day 1-5
CyclophosphamideDrug
Also called CTX
750mg/m² iv on day 6
DoxorubicinDrug
Also called 50mg/m² iv on day 6
DOX
VincristineDrug
Also called VCR
1.4mg/m² iv on day 6
PrednisoneDrug
Also called PED
100mg/m² po on day6-10
| Study group | Role | What they receive |
|---|---|---|
| Decitabine + CHOP regimen | Experimental | decitabine plus CHOP (D-CHOP) administered in 4 week cycles for 6 cycles Receives: Drug: Decitabine; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
| CHOP regimen | Active comparator | cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
from date of inclusion to date of progression, relapse, or death from any cause
Measured: 3 years
Secondary outcomes (3)
Overall Survival
from the date of inclusion to date of death, irrespective of cause
Measured: 3 years
Response rate
complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.)
Measured: 3 years
Adverse Events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieping Chen, Southwest Hospital, China
- Investigators
- Jieping Chen, MD,PhD, Principal investigator, Southwest Hospital, ChinaXi Li, MD, Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553537
- Sponsor's protocol ID
- D-CHOP study
- Status last verified
- May 2018
- First submitted
- 30 May 2018
- Last updated
- 12 Jun 2018
- 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 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Randomized Study to Compare Efficacy and Safety of Decitabine Plus CHOP (D-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT03553537
- Acronym / sponsor ID
- D-CHOP study
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- Peripheral T-cell Lymphoma, decitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 12 Jun 2018 (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.
Primary objective of the study is to compare the efficacy and safety of decitabine plus CHOP (D-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL).
Detailed description
This is a randomized, multi-center, open-label study to compare efficacy and safety of D-CHOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles or decitabine plus CHOP (D-CHOP) administered in 4 week cycles for 6 cycles. In the D-CHOP arm, decitabine will be administered at a dose of 10 mg/m² IV on day 1-5 every 3 weeks. This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary withdrawal.Adverse event of every treatment cycle will be recorded.Therapy efficacy will be evaluated after finishing 3 cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 2 years from the last patient randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decitabine + CHOP regimen | Experimental | Drug: Decitabine, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisonedecitabine plus CHOP (D-CHOP) administered in 4 week cycles for 6 cycles |
| CHOP regimen | Active comparator | Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisonecyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, anapestic large cell lymphoma, enteropathy-associated T cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype and Follicular T-cell lymphoma).
- Males and females of 18 years of age to 80 years of age.
- Patients have not received anti-tumor therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Fit chemotherapy indications and basic requirements, including no obvious abnormal function of heart, liver, lung and kidney: creatine ≤2.0×ULN, total bilirubin ≤2.0mg/dl, transaminases≤3×ULN.
Key exclusion criteria (16 listed)
- Patients with the following PTCL subtypes are excluded; extranodal NNK/T-cell lymphoma, T-prolymphocytic leukemia, T large granular lymphocytic leukemia, chronic lymphoproliferative disorder of NK cells, aggressive natural killer-cell leukemia, adult T-cell leukemia/ lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous T cell lymphoma, breast implant-associated anaplastic large-cell lymphoma.
- Transformed lymphoma.
- Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies.
- Already initiated lymphoma therapy (exept for the prephase treatment specified for this study).
- Patients with primary central nervous system lymphoma or lymphoma involving central nervous system.
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 |
|---|---|---|
| DecitabineAlso: 5-aza-2'-deoxycytidine10mg/m² iv on day 1-5 | Drug | Decitabine + CHOP regimen |
| CyclophosphamideAlso: CTX750mg/m² iv on day 6 | Drug | CHOP regimen, Decitabine + CHOP regimen |
| DoxorubicinAlso: 50mg/m² iv on day 6DOX | Drug | CHOP regimen, Decitabine + CHOP regimen |
| VincristineAlso: VCR1.4mg/m² iv on day 6 | Drug | CHOP regimen, Decitabine + CHOP regimen |
| PrednisoneAlso: PED100mg/m² po on day6-10 | Drug | CHOP regimen, Decitabine + CHOP regimen |
Primary outcome
Progression Free Survival
Time frame: 3 years
from date of inclusion to date of progression, relapse, or death from any cause
3 secondary outcomes
Overall Survival
Time frame: 3 years
Response rate
Time frame: 3 years
Adverse Events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Peripheral T-cell Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
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.
Jieping Chen, MD,PhD principal investigator
Southwest Hospital, China
Xi Li, MD principal investigator
Southwest Hospital, China
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Decitabine, Cyclophosphamide and Doxorubicin in people with Peripheral T-cell Lymphoma, run by Southwest Hospital, China.
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 11 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jieping Chen, MD (+86 13983766908, chenjpxn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 3 years). 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 12 Jun 2018.