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Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedPhase 2NCT02533700

CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL

A Phase 2 study testing CEOP/IVE/GDP chemotherapy regimen and CEOP chemotherapy regimen for 6 cycles in people with Peripheral T-Cell Lymphoma, Not Otherwise Specified and Angioimmunoblastic T Cell Lymphoma, run by Shandong Provincial Hospital at 4 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year PFS and OS for these patients received classic CHOP regimen (cyclophosphamide, vincristin, doxorubicin and prednisone) is less than 30%.High dose intensive chemotherapy doesn't demonstrate better response. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
CEOP/IVE/GDP chemotherapy regimen and CEOP chemotherapy regimen for 6 cycles
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
4 sitesChina
Study dates
Sep 2015to Dec 2020
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Newly diagnosed, histologically confirmed the following pathology subtype according to WHO 2008 classification: peripheral T Cell Lymphoma, not otherwise specified, angioimmunoblastic T cell lymphoma, ALK-negative anaplastic large cell lymphoma, enteropathy associated T cell lymphoma, subcutaneous panniculitis like T cell lymphoma, and hepatosplenic T-cell lymphoma.
  • ≥ 16 years of age.
  • Performance status of 2 or less.
  • Has no history of malignancy.
  • Has radiologically measurable disease.
  • Life expectancy ≥6 months.
  • Voluntarily sign an informed consent.

Who cannot join

  • Pathology subtype with NK/T cell lymphoma, ALK positive-ALCL.
  • Primary central nervous system (CNS) lymphoma.
  • Previous systemic chemotherapy or local therapy.
  • Has undergone hematopoietic stem-cell transplantation (HSCT).
  • Has active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy.
  • Has uncontrollable cardiocerebrovascular, coagulative, autoimmune, or serious infectious disease.
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  • Echocardiography shows left ventricular ejection fraction (LVEF) ≤ 50%.
  • Inadequate renal, hepatic or bone marrow function
  • Active liver or biliary disease.
  • Has other uncontrollable medical condition that may interfere with their participation in the study.
  • Woman in pregnancy or lactation.
  • Patient is known to be positive for Human immunodeficiency virus (HIV) infection.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Shanghai Ruijin Hospital

    Shanghai, Shanghai Municipality, 200000

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With Peripheral T-cell Lymphoma (PTCL)

Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year PFS and OS for these patients received classic CHOP regimen (cyclophosphamide, vincristin, doxorubicin and prednisone) is less than 30%.High dose intensive chemotherapy doesn't demonstrate better response. At present, there is no standardized treatment protocol for this kind of lymphoma. So, clinical trials are encouraged by NCCN for those patients.

Read the detailed description

For the less efficacy of CHOP or CHOP-like regimen, multi-drug combination strategy has been the therapy tendency in PTCL. The novel regimen IVE/MTX (ifosfamide, etoposide，epirubucin/methotrexate)-ASCT(autologous stem-cell transplantation ) was piloted for patients eligible for intensive treatment, followed by auto-stem cell transplantation. Five-years PFS (progression-free survival) and OS (overall survival) were 52% and 60% respectively, significantly improved compared with the historical group treated with anthracycline-based chemotherapy. The encouraged results were extended to the peripheral T cell lymphoma-non specified (PTCL-NOS). Former studies reported that GDP (gemcitabine, cis-platinum, and dexamethasone) compared with CHOP as the therapy strategy for PTCL-NOS (not otherwise specified). The response rate was 78.57% in GDP group and 60.00% in CHOP group respectively. DFS (disease-free survival) was 9.79 and 4.2 months in above two groups. They concluded that GDP is superior with CHOP. The main side-effect of two regimens is hematological toxicity. Furthermore, high-dose combined with ASCT has been the first-line therapy for PTCL. However, only about 30% patients with PTCL have chance to receive ASCT for multiple reasons. So it is urgent to explore new combination-therapy regimen to improve the outcome for patients with PTCL.

The aim of our study is to compare the response and survival rate of CEOP/IVE/GDP (cyclophosphamide, vincristin, epirubucin and prednisone/ ifosfamide, epirubucin, and etoposide/ gemcitabine, cis-platinum, and dexamethasone) with those of CEOP regimen, looking forward to its superiority in efficacy and safety for the newly diagnosed adult patients with PTCL.

Being tested
CEOP/IVE/GDP chemotherapy regimen, CEOP chemotherapy regimen for 6 cycles
Medical subject headings
Lymphoma, T-Cell, Immunoblastic Lymphadenopathy, Enteropathy-Associated T-Cell Lymphoma, Subcutaneous panniculitis-like T-cell lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CEOP/IVE/GDP chemotherapy regimenDrug

    CEOP:

    Cyclophosphamide 750mg/m2, ivgtt D1 Epirubucin 70mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5

    IVE:

    Ifosfamide 2000mg/m2,ivgtt D1-D3 Epirubucin 70mg/m2, ivgtt D1 Etoposide 100mg/m2, ivgtt D1-D3

    GDP:

    Gemcitabine 1g/m2,ivgtt D1,D8 Cis-platinum 25mg/m2, ivgtt D1-D3 Dexamethasone 40mg, ivgtt D1-D4

  • CEOP chemotherapy regimen for 6 cyclesDrug

    CEOP:

    Cyclophosphamide 750mg/m2, ivgtt D1 Epirubucin 70mg/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 NCT02533700
Study groupRoleWhat they receive
CEOP/IVE/GDP chemotherapy regimenExperimental2 cycles of CEOP(cyclophosphamide,vincristine, epirubucin and prednisone),2 cycles of IVE(ifosfamide, epirubucin, etoposide)and 2 cycles of GDP(gemcitabine, cis-platinum, and dexamethasone)
Receives: Drug: CEOP/IVE/GDP chemotherapy regimen
CEOP chemotherapy regimen for 6 cyclesActive comparator6 cycles of CEOP regimen(cyclophosphamide,vincristin,epirubucin and prednisone)
Receives: Drug: CEOP chemotherapy regimen for 6 cycles

What is being measured

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

  1. Percentage of patients with complete remission （CR）

    Measured: 6 months

Secondary outcomes (4)

  1. progression-free survival

    Measured: 2 year since randomization

  2. overall survival

    Measured: 2 year since randomization

  3. overall response rate

    Measured: 6 months

  4. adverse events

    Measured: from randomization to one month after last cycle of treatment

Timeline

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

  1. First posted27 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionMay 2019
  4. Study completionDec 2020 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02533700
Sponsor's protocol ID
WXin
Status last verified
Mar 2020
First submitted
18 Jul 2015
Last updated
10 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Cai MC, Cheng S, Wang X, Hu JD, Song YP, Huang YH, Yan ZX, Jiang YJ, Fang XS, Zheng XY, Dong LH, Ji MM, Wang L, Xu PP, Zhao WL. CEOP/IVE/GDP alternating regimen compared with CEOP as the first-line therapy for newly diagnosed patients with peripheral T cell lymphoma: results from a phase 2, multicenter, randomized, controlled clinical trial. Genome Med. 2020 Apr 30;12(1):41. doi: 10.1186/s13073-020-00739-0.

    PubMed 32349779

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CEOP/IVE/GDP chemotherapy regimen and CEOP chemotherapy regimen for 6 cycles in people with Peripheral T-Cell Lymphoma, Not Otherwise Specified and Angioimmunoblastic T Cell Lymphoma, run by Shandong Provincial Hospital at 4 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 7 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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Percentage of patients with complete remission （CR） (time frame: 6 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 NCT02533700, 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 10 Mar 2020.

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