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

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ClinicalTrials.gov Identifier: NCT03952572
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jun Zhu, Peking University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Doxorubicin

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




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



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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952572


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

Locations
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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
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Study Chair: Jun Zhu, PHD Beijing Cancer Hospital

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Responsible Party: Jun Zhu, Principal Investigator, Peking University
ClinicalTrials.gov Identifier: NCT03952572     History of Changes
Other Study ID Numbers: CSPC-DMS-LY-02
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids