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Peripheral T-cell LymphomaPhase 3NCT03952572

Efficacy and Safety of CDOP vs CHOP for Newly Diagnosed Peripheral T-cell Lymphoma

A Phase 3 study testing Cyclophosphamide, pegylated liposomal doxorubicin and Vincristine in people with Peripheral T-cell Lymphoma, run by Peking University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Primary objective of the study is to compare the efficacy and safety of CDOP versus CHOP for newly diagnosed peripheral T-cell lymphoma (PTCL). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Peripheral T-cell Lymphoma
What is being tested?
Cyclophosphamide, pegylated liposomal doxorubicin and Vincristine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
1 siteChina
Study dates
10 May 2019to 30 Apr 2023
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 75 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（PTCL-NOS）, angioimmunoblastic T cell lymphoma（AITL）, anaplastic large cell lymphoma（ALCL）and other peripheral T-cell lymphoma(except NK/T cell lymphoma);
  • Males and females of 18 years of age to 75 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0- 2.
  • At least 1 single size measurable lesions, CT or PET-CT scan shows more than 15mm.
  • Estimated survival time ≥ 6 months
  • Liver function: transaminases≤3×ULN，or transaminases≤3×ULN for liver metastasis，total bilirubin ≤1.5ULN，or total bilirubin ≤2.5ULN for Gilbert's syndrome
Show all 11Show fewer
  • Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥ 60 ml / min ( standard Cockcroft-Gault formula);
  • peripheral hemogram: WBC≥3.0×10^9/L, ANC≥1.5×10^9/L, Hb≥90g/L, PLT≥75×10^12/L.
  • Cardiac ultrasound LVEF≥55%;
  • New York Heart Association (NYHA) heart function classification is I grade;
  • sign informed consent.

Who cannot join

  • Patients with primary or secondary central nervous system lymphoma；
  • Serious heart disease, including but not limited to:
  • 1)Significant ventricular arrhythmia or high degree atrioventricular block (Mobitz II or third degree atrioventricular block); 2) unstable angina; 3) clinically significant heart valve disease; 4) Electrocardiogram shows transmural myocardial infarction; 5) Uncontrollable hypertension; 3. interstitial pneumonia, allergic asthma or severe allergic medical history; 4.Patients with other malignancies in the past or now (except basal cell carcinoma, squamous-cell carcinoma or carcinoma in situs of cervix that has been adequately treated), 5.HIV antibody positivity; 6.Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable), acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibody positivity, HCV RNA negative acceptable) 7.Pregnancy or lactation period 8.Patients with Organ transplantation 9.Patients with serious uncontroled acute infection 10.High doses of hormones are contraindicated, such as uncontrolled hyperglycemia, stomach ulcers or Mental illness, etc.
  • 11.Patients with severe neurological or psychiatric history, including dementia or epilepsy 12.The researchers considered that patients are not suitable for the study

Trial locations and contacts

1 site in 1 country.

Jun Zhu, PHD contact

0086-10-88196115

zj@bjcancer.org

Yuqin Song, PHD contact

0086-10-88196115

songyuqin622@sina.com

China1 site, 1 recruiting

  • Peking University Cancer Hospital & Institute

    Beijing, Beijing Municipality, 100142

    Jun Zhu, zj@bjcancer.org

    Yuqin Song, songyuqin622@sina.com

    Recruiting

Other trials in China

About this study

Official title: Open-label Multi-center Randomized Non-inferiority Study to Compare Efficacy and Safety of Pegylated Liposomal Doxorubicin Versus Doxorubicin for Newly Diagnosed Peripheral T-cell Lymphoma

Primary objective of the study is to compare the efficacy and safety of CDOP versus CHOP for newly diagnosed peripheral T-cell lymphoma (PTCL).

Read the detailed description

This is a open-label, multi-center, randomized, non-inferiority study to compare efficacy and safety of CDOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven newly diagnosed PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, pegylated liposomal doxorubicin, vincristine and prednisone (CDOP) administered in 3 week cycles for 6 cycles or cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.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 2 cycles, 4cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 2 years from the last patient randomized.

Being tested
Cyclophosphamide, pegylated liposomal doxorubicin, Vincristine, Prednisone, Doxorubicin
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.

  • CyclophosphamideDrug

    Also called CTX

    750mg/m² ivgtt on day 1

  • pegylated liposomal doxorubicinDrug

    Also called PLD

    40mg/m² ivgtt on day 1

  • VincristineDrug

    Also called VCR

    1.4mg/m²(Maximum 2 mg) ivgtt on day 1

  • PrednisoneDrug

    Also called PED

    Prednisone100mg/m² po on day1-5

  • DoxorubicinDrug

    Also called DOX

    50mg/m² ivgtt on day 1

Study groups in NCT03952572
Study groupRoleWhat they receive
CDOP regimenExperimentalcyclophosphamide, pegylated liposomal doxorubicin, vincristine and prednisone (CDOP) administered in 3 week cycles for 6 cycles.
Receives: Drug: Cyclophosphamide; Drug: pegylated liposomal doxorubicin; Drug: Vincristine; Drug: Prednisone
CHOP regimenActive comparatorcyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.
Receives: Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone; Drug: Doxorubicin

What is being measured

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

  1. Response rate

    complete response (CR) and partial response (PR) rates, using the standard response criteria

    Measured: 2 years

Secondary outcomes (4)

  1. Progression Free Survival

    from date of inclusion to date of progression, relapse, or death from any cause

    Measured: 2 years

  2. Overall Survival

    from the date of inclusion to date of death, irrespective of cause

    Measured: 2 years

  3. Cardiac toxicity

    cardiotoxity Congestive heart failure with clinical symptoms, or no symptoms but an abnormal LVEF

    Measured: 2 years

  4. 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: 2 years

Timeline

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

  1. First posted16 May 2019
  2. Study start10 May 2019
  3. Primary completion30 Apr 2023 (estimated)
  4. Study completion30 Apr 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
244 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03952572
Sponsor's protocol ID
CSPC-DMS-LY-02
Status last verified
May 2019
First submitted
10 May 2019
Last updated
16 May 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclophosphamide, pegylated liposomal doxorubicin and Vincristine in people with Peripheral T-cell Lymphoma, run by Peking University 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 11 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 16 May 2019. 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 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 Jun Zhu, PHD (0086-10-88196115, zj@bjcancer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 2 years). 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 NCT03952572.

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 16 May 2019.

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