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ALK-negative Anaplastic Large Cell LymphomaPhase 4NCT01746992

CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma

A Phase 4 study testing Cyclophosphamide 750mg/m2, Vincristine 1.4mg/m2 and Doxorubicin 50mg/m2 in people with ALK-negative Anaplastic Large Cell Lymphoma and Peripherial T Cell Lymphoma,Not Otherwise Specified, run by Ruijin Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

T cell lymphoma is a heterogenic malignancy with poor outcome. Five-year PFS and OS of the patients recieved classic CHOP regimen(cyclophosphamide,vincristin,doxorubicin and predisone)is less than 30%.High dose intensive chemotherapy doesn't demonstrate better response. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Cyclophosphamide 750mg/m2, Vincristine 1.4mg/m2 and Doxorubicin 50mg/m2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
Sep 2012to Dec 2018
Phase
Phase 4
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • pathologic verified mature T cell lymphoma,including ALK-negative anaplastic large cell lymphoma,peripherial T cell lymphoma-non specific type,angioimmunoblastic T cell lymphoma,enteropathy associated T cell lymphoma and hepatosplenic T cell lymphoma
  • SGOT/SGPT no more than 2 times of UNL
  • serum creatinine no more than 1.5 times of UNL
  • signed informed consent

Who cannot join

  • woman in pregnancy or lactation
  • allergic to any intervention drug
  • insuitable to the study due to severe complication
  • enrolled to other study during the past 6 months

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin hospital

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: An Open-label,Multicenter Randomised Study of CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for the New Diagnosed Young Patients With T Cell Non-hodgkin Lymphoma

T cell lymphoma is a heterogenic malignancy with poor outcome. Five-year PFS and OS of the patients recieved classic CHOP regimen(cyclophosphamide,vincristin,doxorubicin and predisone)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.

Between 1994 and 1998,the Scotland and Newcastle Lymphoma Group prospectively collected data on newly diagnosed patients with enteropathy associated T-cell lymphoma (EATL)in the Northern Region of England and Scotland,which is a rare and aggressive type of peripheral T-cell lymphoma.The novel regimen IVE/MTX (ifosfamide, vincristine, etoposide/methotrexate)-ASCT was piloted for patients eligible for intensive treatment,followed by auto-stem cell transplantation.Five-years PFS and OS were 52% and 60% respectively, significantly improved compared with the historical group treated with anthracycline-based chemotherapy. The encouraged results were extended to the peripherial T cell lymphoma-non specified(PTCL-nos).

Past studies suggested pirarubicin was more active to the T cell lymphoma than doxorubicin in vitro based on its high concentration in tumor cells. Clinical data also presented equivalent even superior efficacy of pirarubicin with lower toxicity than doxorubicin. The aim of our study is to compare the response and survival rate of CTOP/ITE/MTX (cyclophosphamide, vincristin,pirarubicin and predisone/ ifosfamide, pirarubicin, etoposide/methotrexate) with those of CHOP regimen,looking forward to its superiority in efficacy and safety for the de novo young patients with T cell lymphoma.

Being tested
Cyclophosphamide 750mg/m2, Vincristine 1.4mg/m2, Doxorubicin 50mg/m2, prednisone 60mg/m2, ifosfamide 2000mg/m2
Medical subject headings
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.

  • Cyclophosphamide 750mg/m2Drug

    Also called CTX

    day 1 in both arms

  • Vincristine 1.4mg/m2Drug

    Also called VCR

    day 1

  • Doxorubicin 50mg/m2Drug

    Also called ADM

    day 1

  • prednisone 60mg/m2Drug

    Also called PRED

    day1-day5

  • ifosfamide 2000mg/m2Drug

    Also called IFO

    day 22-day 24

  • pirarubicin 50mg/m2Drug

    Also called THP

    day 1

  • pirarubicin 25mg/m2Drug

    Also called THP

    day 22

  • Etoposide phosphate 100mg/m2Drug

    Also called VP-16

    day 22-day 24

  • methotrexate 1500mg/m2Drug

    Also called MTX

    day 43

Study groups in NCT01746992
Study groupRoleWhat they receive
pirarubicinExperimental3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate
Receives: Drug: Cyclophosphamide 750mg/m2; Drug: Vincristine 1.4mg/m2; Drug: prednisone 60mg/m2; Drug: ifosfamide 2000mg/m2; Drug: pirarubicin 50mg/m2; Drug: pirarubicin 25mg/m2; Drug: Etoposide phosphate 100mg/m2; Drug: methotrexate 1500mg/m2
doxorubicinActive comparator8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)
Receives: Drug: Cyclophosphamide 750mg/m2; Drug: Vincristine 1.4mg/m2; Drug: Doxorubicin 50mg/m2; Drug: prednisone 60mg/m2

What is being measured

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

  1. complete remission rate

    Measured: 6 months

  2. 3-year PFS

    Measured: 3 years

Secondary outcomes (2)

  1. overall response rate

    Measured: 6 months

  2. 3-year os

    Measured: 3 years

Timeline

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

  1. First posted11 Dec 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2018 (estimated)
  4. Study completionDec 2018 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01746992
Sponsor's protocol ID
CTOP
Status last verified
Nov 2017
First submitted
4 Dec 2012
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cyclophosphamide 750mg/m2, Vincristine 1.4mg/m2 and Doxorubicin 50mg/m2 in people with ALK-negative Anaplastic Large Cell Lymphoma and Peripherial T Cell Lymphoma,Not Otherwise Specified, run by Ruijin Hospital at 1 site 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 4 inclusion and 4 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 14 Nov 2017. 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 remission rate (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT01746992.

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 14 Nov 2017; AzTrials last refreshed its copy on 29 Oct 2026.

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