Back to results

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

Primary Purpose

Peripheral T-cell Lymphoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Cyclophosphamide

pegylated liposomal doxorubicin

Vincristine

Prednisone

Doxorubicin

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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.

Exclusion Criteria:

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

Sites / Locations

Peking University Cancer Hospital & InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CDOP regimen

CHOP regimen

Arm Description

cyclophosphamide, pegylated liposomal doxorubicin, vincristine and prednisone (CDOP) administered in 3 week cycles for 6 cycles.

cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.

Outcomes

Primary Outcome Measures

Response rate

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

Secondary Outcome Measures

Progression Free Survival

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

Overall Survival

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

Cardiac toxicity

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

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

Full Information

NCT ID

NCT03952572

First Posted

May 10, 2019

Last Updated

May 15, 2019

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT03952572

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 10, 2019 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CDOP regimen

Arm Type

Experimental

Arm Description

cyclophosphamide, pegylated liposomal doxorubicin, vincristine and prednisone (CDOP) administered in 3 week cycles for 6 cycles.

Arm Title

CHOP regimen

Arm Type

Active Comparator

Arm Description

cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

CTX

Intervention Description

750mg/m² ivgtt on day 1

Intervention Type

Drug

Intervention Name(s)

pegylated liposomal doxorubicin

Other Intervention Name(s)

PLD

Intervention Description

40mg/m² ivgtt on day 1

Intervention Type

Drug

Intervention Name(s)

Vincristine

Other Intervention Name(s)

VCR

Intervention Description

1.4mg/m²(Maximum 2 mg) ivgtt on day 1

Intervention Type

Drug

Intervention Name(s)

Prednisone

Other Intervention Name(s)

PED

Intervention Description

Prednisone100mg/m² po on day1-5

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Other Intervention Name(s)

DOX

Intervention Description

50mg/m² ivgtt on day 1

Primary Outcome Measure Information:

Title

Response rate

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Progression Free Survival

Description

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

Time Frame

2 years

Title

Overall Survival

Description

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

Time Frame

2 years

Title

Cardiac toxicity

Description

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

Time Frame

2 years

Title

Adverse Events

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Zhu, PHD

Phone

0086-10-88196115

zj@bjcancer.org

First Name & Middle Initial & Last Name or Official Title & Degree

Yuqin Song, PHD

Phone

0086-10-88196115

songyuqin622@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Zhu, PHD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Peking University Cancer Hospital & Institute

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Zhu

zj@bjcancer.org

First Name & Middle Initial & Last Name & Degree

Yuqin Song

songyuqin622@sina.com

First Name & Middle Initial & Last Name & Degree

Yuqin Song

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs