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T Cell Non-Hodgkin's LymphomaPhase 1/2NCT02987244

Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma

A Phase 1/2 study testing Chidamide, Cyclophosphamide and Epirubicin in people with T Cell Non-Hodgkin's Lymphoma, run by Peking Union Medical College Hospital at 2 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to determine determine the maximum tolerated dose (MTD) and safety of the combination of Chidamide combined with CHOEP(cyclophosphamide， epirubicin,vindesine, etoposide and prednisone) regimen as first line treatment in newly-diagnosed T-NHL. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
T Cell Non-Hodgkin's Lymphoma
What is being tested?
Chidamide, Cyclophosphamide and Epirubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesChina
Study dates
Mar 2016to Mar 2023
Phase
Phase 1/2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly-diagnosed T cell non-Hodgkin's lymphoma patients. Diagnosis of T cell NHL was performed by morphologic analysis of tissue pathological specimens along with Immunohistochemistry (IHC)
  • ECOG≤2
  • At least one or more unidimensionally measurable lesions (≥1 cm by CT scan or skin lesions or a measurable lesion by physical examination)
  • Sign the Informed consent
  • Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.
  • Male subjects must agree to use condoms throughout study drug therapy.

Who cannot join

  • T lymphoblastic leukemia/lymphoma
  • Bone marrow involvement and lymphoma cell ≥ 25%
  • Aplastic large T cell lymphoma - ALK positive
  • NK/T-cell lymphoma
  • Mycosis Fungoides/Sezary Syndrome
  • Pre-existing uncontrolled active infection
Show all 12Show fewer
  • Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria
  • Grade 3 or 4 peripheral neuropathy
  • Pregnancy or active lactation
  • Co-existing tumors
  • Impaired renal/ hepatic function (serum creatinine >1.5 mg/dl or creatinine clearance <60 ml/min or serum transaminases/ bilirubin ≥3 upper limits of normal）
  • History of mental illness

Trial locations and contacts

2 sites in 1 country.

Wei Zhang, M.D contact

+86 136 8147 3557

vv1223@vip.sina.com

Yan Zhang, M.D contact

+86 13810000485

zhangyan10659@pumch.cn

China2 sites, 2 recruiting

  • Peking Union medical college hospital

    Beijing, Beijing Municipality, 100730

    Wei Zhang

    Recruiting

  • Tianjin medical universty cancer institute & hospital

    Tianjin, Tianjin Municipality, 300060

    Recruiting

Other trials in China

About this study

The purpose of this study is to determine determine the maximum tolerated dose (MTD) and safety of the combination of Chidamide combined with CHOEP(cyclophosphamide， epirubicin,vindesine, etoposide and prednisone) regimen as first line treatment in newly-diagnosed T-NHL.

Read the detailed description

Chidamide+Cyclophosphamide+Epirubicin+Vindesine+Etoposide+Prednisone Six cycles of therapy administered every 28 days were planned. Cyclophosphamide 750mg/m2 IV d1; epirubicin 70mg/m2 IV d1; Vindesine 4mg IV d1; etoposide 100mg IV d1-3; prednisone 60mg/m2 PO d1-5.

Chidamide:

Phase I: Patients were treated at the following bortezomib dose levels: 15, 20, and 25 mg twice per week.

Dose escalation and reduction were on the basis of the continual reassessment method, with at least two patients per dose level and no dose level skipped. No intrapatient dose escalation will be allowed. If one patient experienced dose-limiting toxicity (DLT), three additional patients were added to the dose level. If two of six patients experienced DLT, the previous dose level was declared the MTD. If only one of six patients experienced DLT, dose escalation was permitted to continue. DLT refers only to toxic events that occur during the first cycle of treatment.

At least 9(3+3+3) patients will be enrolled in Phase I study. Phase II: If MTD was not reached at 25mg dose level of Chidamide. The followed study will use 20mg twice per week as experimental dose.

After 3 Cycles, patients who become PD should withdraw the trial and receive other regimens; patients who become CR and eligible for auto-SCT will undergo auto-SCT; patients who get PR will receive 3 more cycles C-CHOEP regimen treatment, CR patients in them undergo auto-SCT, non-CR patients undergo follow-up phase.

All the patients will continue to receive chidamide treatment until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.

During follow-uo phase, surveillance imaging with CT scans can be performed every 6 months up to the first 2 years, followed by doctor visit every 6 months up to 5 years or the disease relapses.

from recruiting the first subject until the last recruited subject finished his 2 years follow-up phase or the disease relapsed

Being tested
Chidamide, Cyclophosphamide, Epirubicin, Vindesine, Etoposide
Keywords
Chidamide, T Cell Non-Hodgkin's Lymphoma
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.

  • ChidamideDrug

    Also called epidaza

    Six cycles of therapy will be administered,and each cycle of treatment is 28 days.

    Phase I: Patients were treated at the following dose levels: 15, 20, and 25 mg twice per week to determine the MDT Phase II: If MTD was not reached at 25mg dose level of Chidamide. The followed study will use 20mg twice per week as experimental dose.

  • CyclophosphamideDrug

    Cyclophosphamide(750mg/m2) was administered intravenously on d1

  • EpirubicinDrug

    epirubicin (70mg/m2)was administered intravenously on d1;

  • VindesineDrug

    vindesine (4mg)was administered intravenously on d1;

  • EtoposideDrug

    etoposide (100mg) was administered intravenously on d1,2,3.

  • PrednisoneDrug

    prednisone (60mg/m2)was administered intravenously by oral d1-5.

Study groups in NCT02987244
Study groupRoleWhat they receive
C-CHOEPExperimentalexperimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.
Receives: Drug: Chidamide; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vindesine; Drug: Etoposide; Drug: Prednisone

What is being measured

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

  1. 2 years progression-free survival

    from recruiting the first subject until the last recruited subject finished his 2 years follow-up phase or the disease relapsed

    Measured: the overall time frame is up to 48 months

Secondary outcomes (3)

  1. 5 years overall survival（OS）

    from recruiting the first subject until the last recruited subject finished his 5 years follow-up phase

    Measured: the overall time frame is up to 84 months

  2. overall response rate(ORR) and complete remission rate(CR）

    the last recruited subject finished 4 cycle C-CHOEP regimen

    Measured: the overall time frame is up to 30 months

  3. adverse events

    throughout the treatment and until 30 days after the administration of the last dose of a study drug

    Measured: the overall time frame is up to 84 months

Timeline

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

  1. First posted8 Dec 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionMar 2020 (estimated)
  4. Study completionMar 2023 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02987244
Sponsor's protocol ID
PUMCH-NHL-002
Status last verified
Dec 2016
First submitted
2 Dec 2016
Last updated
8 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Dong M, Ning ZQ, Xing PY, Xu JL, Cao HX, Dou GF, Meng ZY, Shi YK, Lu XP, Feng FY. Phase I study of chidamide (CS055/HBI-8000), a new histone deacetylase inhibitor, in patients with advanced solid tumors and lymphomas. Cancer Chemother Pharmacol. 2012 Jun;69(6):1413-22. doi: 10.1007/s00280-012-1847-5. Epub 2012 Feb 24.

    PubMed 22362161

  • Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. doi: 10.1093/annonc/mdv237. Epub 2015 Jun 23.

    PubMed 26105599

  • Wang W, Zhang W, Su LP, Liu LH, Gao YH, Wang QS, Su H, Song YQ, Zhang HL, Shen J, Jing HM, Wang SY, Cen XN, Liu H, Liu AC, Li ZJ, Luo JM, He JX, Wang JW, O'Connor OA, Zhou DB. Efficacy of chidamide maintenance therapy versus autologous stem cell transplantation versus observation as a post-remission choice in the survival of adult patients with peripheral T-cell lymphoma: Post hoc analysis of a prospective, multicenter, phase 2 study in China. Ann Hematol. 2024 Aug;103(8):3061-3069. doi: 10.1007/s00277-024-05708-w. Epub 2024 May 28.

    PubMed 38805037

  • Zhang Y, Zhang W, Li J, Duan M, Han B, Zhu T, Zhuang J, Cai H, Cao X, Chen M, Zhou D. Gemcitabine, cisplatin, and dexamethasone (GDP) in combination with methotrexate and pegaspargase is active in newly diagnosed peripheral T cell lymphoma patients: a phase 2, single-center, open-label study in China. Ann Hematol. 2019 Jan;98(1):143-150. doi: 10.1007/s00277-018-3488-1. Epub 2018 Sep 12.

    PubMed 30209556

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Chidamide, Cyclophosphamide and Epirubicin in people with T Cell Non-Hodgkin's Lymphoma, run by Peking Union Medical College Hospital at 2 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 12 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 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei Zhang, M.D (+86 136 8147 3557, vv1223@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2 years progression-free survival (time frame: the overall time frame is up to 48 months). 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 NCT02987244, which also lists 4 linked publications.

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 8 Dec 2016.

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