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Peripheral T-cell LymphomaPhase 2NCT04480099

Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

A Phase 2 study testing CHOP and CHOP+X in people with Peripheral T-cell Lymphoma, run by Ruijin Hospital at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This prospective，multi-center，open-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral T-cell Lymphoma
What is being tested?
CHOP and CHOP+X
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
7 sitesChina
Study dates
29 Jul 2020to Apr 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification with enough tumor sample for NGS
  • Treatment naive
  • Age ≥ 18 years
  • Must has measurable lesion in CT or PET-CT prior to treatment
  • ECOG 0,1,2
  • Informed consented

Who cannot join

  • ALCL,ALK positive, NK/T-cell leukemia, adult T-cell lymphoma/leukemia, T-LGL
  • Has accepted localized or systemic anti-lymphoma treatment
  • Has accepted autologous Stem cell transplantation before
  • History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
  • Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  • Primary CNS lymphoma
Show all 14Show fewer
  • Left EF≤ 50%
  • Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/ L ;Platelet<50*10^9/L; ALT or AST >2*ULN; Creatinine>1.5*ULN
  • Other uncontrollable medical condition that may that may interfere the participation of the study
  • Not able to comply to the protocol for mental or other unknown reasons
  • Patients with mentally disorders or other reasons unable to fully comply with the study protocol
  • Pregnant or lactation
  • HIV infection
  • HBV-DNA or HCV-RNA positive

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Department of Hematology, Peking University Third Hospital, Beijing, China

    Beijing

  • Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China

    Chengdu

  • Department of Hematology, Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Union Hospital, Fujian Institute of Hematology, Fuzhou, China

    Fuzhou

  • Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China

    Shandong

  • Shanghai Ruijin Hospital

    Shanghai

  • Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

    Wuhan

  • Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

    Wuhan

Other trials in China

About this study

Official title: The Efficacy and Safety of Targeted Drug in Combination With Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in the Treatment of Newly Diagnosed Peripheral T-Cell Lymphoma

This prospective，multi-center，open-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma.

Read the detailed description

Peripheral T-cell lymphoma (PTCL）is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. Patients with PTCL still have poor treatment response and prognosis under conventional CHOP regimen. There is no standard of care for those patients. Targeted drugs are warranted in this group of patients to improve survival. This prospective，multi-center，open-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma.

Being tested
CHOP, CHOP+X
Keywords
Peripheral T-cell lymphoma, Targeted therapy
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.

  • CHOPDrug

    Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses

  • CHOP+XDrug

    X: X(i.e. targeted drug) will decided by NGS results as following. Decitabine 10mg/m2 ivgtt D-5 to-1 if with TP53 gene muation. Azacitadine 100mg/day ivgtt D-7 to -1 if with TET2/KMT2D gene mutation. Chidamide 20mg/day po D1,4,8,11 if with CREBBP/EP300 gene mutation. Lenalidomide 25mg/day po D1-10 if without gene mutation above. X will be added from the second cycle CHOP:Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses

Study groups in NCT04480099
Study groupRoleWhat they receive
CHOPActive comparatorPatients in this arm will receive conventional CHOP regimen for 6 cycles
Receives: Drug: CHOP
CHOP+XExperimentalPatients in this arm will receive targeted drug in combination with conventional CHOP regimen for 6 cycles, based on NGS results
Receives: Drug: CHOP+X

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate

    Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria

    Measured: At the end of Cycle 6 (each cycle is 21 days)

Secondary outcomes (7)

  1. Overall response rate

    Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria

    Measured: At the end of Cycle 6 (each cycle is 21 days)

  2. Progression free survival

    Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  3. Overall survival

    Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  4. Duration of response

    Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  5. Treatment related mortality

    Percentage of death related with treatment on the basis of investigator assessments

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  6. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  7. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores

    The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.

    Measured: Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start29 Jul 2020
  3. Primary completion20 Apr 2023
  4. Study completionApr 2024 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04480099
Sponsor's protocol ID
RJ-PTCL-1
Status last verified
Jun 2023
First submitted
19 Jul 2020
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cai MC, Cheng S, Jing HM, Liu Y, Cui GH, Niu T, Shen JZ, Huang L, Wang X, Huang YH, Wang L, Xu PP, Zhao WL. Targeted agents plus CHOP compared with CHOP as the first-line treatment for newly diagnosed patients with peripheral T-cell lymphoma (GUIDANCE-03): an open-label, multicentre phase 2 clinical trial. Lancet Reg Health West Pac. 2024 Jul 29;50:101160. doi: 10.1016/j.lanwpc.2024.101160. eCollection 2024 Sep.

    PubMed 39175480

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CHOP and CHOP+X in people with Peripheral T-cell Lymphoma, run by Ruijin Hospital at 7 sites in 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 6 inclusion and 14 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 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. 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?

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?

Complete response rate (time frame: At the end 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?

On the ClinicalTrials.gov record for NCT04480099, which also lists 1 linked publication.

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 13 Jun 2023.

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