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出境医 / 临床实验 / Efficacy and Safety of CDOP vs CHOP for Newly Diagnosed Peripheral T-cell Lymphoma

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

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).

Condition or disease Intervention/treatment Phase
Peripheral T-cell Lymphoma Drug: Cyclophosphamide Drug: pegylated liposomal doxorubicin Drug: Vincristine Drug: Prednisone Drug: Doxorubicin Phase 3

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: CDOP regimen
cyclophosphamide, pegylated liposomal doxorubicin, vincristine and prednisone (CDOP) administered in 3 week cycles for 6 cycles.
Drug: Cyclophosphamide
750mg/m² ivgtt on day 1
Other Name: CTX

Drug: pegylated liposomal doxorubicin
40mg/m² ivgtt on day 1
Other Name: PLD

Drug: Vincristine
1.4mg/m²(Maximum 2 mg) ivgtt on day 1
Other Name: VCR

Drug: Prednisone
Prednisone100mg/m² po on day1-5
Other Name: PED

Active Comparator: CHOP regimen
cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.
Drug: Cyclophosphamide
750mg/m² ivgtt on day 1
Other Name: CTX

Drug: Vincristine
1.4mg/m²(Maximum 2 mg) ivgtt on day 1
Other Name: VCR

Drug: Prednisone
Prednisone100mg/m² po on day1-5
Other Name: PED

Drug: Doxorubicin
50mg/m² ivgtt on day 1
Other Name: DOX

Outcome Measures
Primary Outcome Measures :
  1. Response rate [ Time Frame: 2 years ]
    complete response (CR) and partial response (PR) rates, using the standard response criteria


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]
    from date of inclusion to date of progression, relapse, or death from any cause

  2. Overall Survival [ Time Frame: 2 years ]
    from the date of inclusion to date of death, irrespective of cause

  3. Cardiac toxicity [ Time Frame: 2 years ]
    cardiotoxity Congestive heart failure with clinical symptoms, or no symptoms but an abnormal LVEF

  4. Adverse Events [ Time Frame: 2 years ]
    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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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);
  2. Males and females of 18 years of age to 75 years of age.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0- 2.
  4. At least 1 single size measurable lesions, CT or PET-CT scan shows more than 15mm.
  5. Estimated survival time ≥ 6 months
  6. 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
  7. Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥ 60 ml / min ( standard Cockcroft-Gault formula);
  8. peripheral hemogram: WBC≥3.0×10^9/L, ANC≥1.5×10^9/L, Hb≥90g/L, PLT≥75×10^12/L.
  9. Cardiac ultrasound LVEF≥55%;
  10. New York Heart Association (NYHA) heart function classification is I grade;
  11. sign informed consent.

Exclusion Criteria:

  1. Patients with primary or secondary central nervous system lymphoma;
  2. 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

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jun Zhu, PHD 0086-10-88196115 zj@bjcancer.org
Contact: Yuqin Song, PHD 0086-10-88196115 songyuqin622@sina.com

Locations
Layout table for location information
China, Beijing
Peking University Cancer Hospital & Institute Recruiting
Beijing, Beijing, China, 100142
Contact: Jun Zhu       zj@bjcancer.org   
Contact: Yuqin Song       songyuqin622@sina.com   
Sub-Investigator: Yuqin Song         
Sponsors and Collaborators
Peking University
Investigators
Layout table for investigator information
Study Chair: Jun Zhu, PHD Beijing Cancer Hospital
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE May 10, 2019
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
Response rate [ Time Frame: 2 years ]
complete response (CR) and partial response (PR) rates, using the standard response criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Progression Free Survival [ Time Frame: 2 years ]
    from date of inclusion to date of progression, relapse, or death from any cause
  • Overall Survival [ Time Frame: 2 years ]
    from the date of inclusion to date of death, irrespective of cause
  • Cardiac toxicity [ Time Frame: 2 years ]
    cardiotoxity Congestive heart failure with clinical symptoms, or no symptoms but an abnormal LVEF
  • Adverse Events [ Time Frame: 2 years ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of CDOP vs CHOP for Newly Diagnosed Peripheral T-cell Lymphoma
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral T-cell Lymphoma
Intervention  ICMJE
  • Drug: Cyclophosphamide
    750mg/m² ivgtt on day 1
    Other Name: CTX
  • Drug: pegylated liposomal doxorubicin
    40mg/m² ivgtt on day 1
    Other Name: PLD
  • Drug: Vincristine
    1.4mg/m²(Maximum 2 mg) ivgtt on day 1
    Other Name: VCR
  • Drug: Prednisone
    Prednisone100mg/m² po on day1-5
    Other Name: PED
  • Drug: Doxorubicin
    50mg/m² ivgtt on day 1
    Other Name: DOX
Study Arms  ICMJE
  • Experimental: CDOP regimen
    cyclophosphamide, pegylated liposomal doxorubicin, vincristine and prednisone (CDOP) administered in 3 week cycles for 6 cycles.
    Interventions:
    • Drug: Cyclophosphamide
    • Drug: pegylated liposomal doxorubicin
    • Drug: Vincristine
    • Drug: Prednisone
  • Active Comparator: CHOP regimen
    cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.
    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Vincristine
    • Drug: Prednisone
    • Drug: Doxorubicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
244
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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);
  2. Males and females of 18 years of age to 75 years of age.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0- 2.
  4. At least 1 single size measurable lesions, CT or PET-CT scan shows more than 15mm.
  5. Estimated survival time ≥ 6 months
  6. 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
  7. Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥ 60 ml / min ( standard Cockcroft-Gault formula);
  8. peripheral hemogram: WBC≥3.0×10^9/L, ANC≥1.5×10^9/L, Hb≥90g/L, PLT≥75×10^12/L.
  9. Cardiac ultrasound LVEF≥55%;
  10. New York Heart Association (NYHA) heart function classification is I grade;
  11. sign informed consent.

Exclusion Criteria:

  1. Patients with primary or secondary central nervous system lymphoma;
  2. 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jun Zhu, PHD 0086-10-88196115 zj@bjcancer.org
Contact: Yuqin Song, PHD 0086-10-88196115 songyuqin622@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952572
Other Study ID Numbers  ICMJE CSPC-DMS-LY-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jun Zhu, Peking University
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jun Zhu, PHD Beijing Cancer Hospital
PRS Account Peking University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP