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

NCT03952572 | Unknown Phase 3

• 1 other identifier: CSPC-DMS-LY-02
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Response rate

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

  2 years

Secondary Outcomes (4)

• Progression Free Survival

  2 years

• Overall Survival

  2 years

• Cardiac toxicity

  2 years

• Adverse Events

  2 years

Study Arms (2)

CDOP regimen

EXPERIMENTAL

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

Drug: Cyclophosphamide; Drug: pegylated liposomal doxorubicin; Drug: Vincristine; Drug: Prednisone

CHOP regimen

ACTIVE COMPARATOR

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

Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone; Drug: Doxorubicin

Interventions

Cyclophosphamide DRUG

750mg/m² ivgtt on day 1

Also known as: CTX

CDOP regimen; CHOP regimen

pegylated liposomal doxorubicin DRUG

40mg/m² ivgtt on day 1

Also known as: PLD

CDOP regimen

Vincristine DRUG

1.4mg/m²(Maximum 2 mg) ivgtt on day 1

Also known as: VCR

CDOP regimen; CHOP regimen

Prednisone DRUG

Prednisone100mg/m² po on day1-5

Also known as: PED

CDOP regimen; CHOP regimen

Doxorubicin DRUG

50mg/m² ivgtt on day 1

Also known as: DOX

CHOP regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with primary or secondary central nervous system lymphoma；
• Serious heart disease, including but not limited to:
• )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.
• Patients with severe neurological or psychiatric history, including dementia or epilepsy 12.The researchers considered that patients are not suitable for the study

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Cyclophosphamide; liposomal doxorubicin; 1-dodecylpyridoxal; Vincristine; Prednisone; Doxorubicin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Jun Zhu, PHD

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

Central Study Contacts

Jun Zhu, PHD

CONTACT

0086-10-88196115; zj@bjcancer.org

Yuqin Song, PHD

CONTACT

0086-10-88196115; songyuqin622@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 16, 2019
• Study Start: May 10, 2019
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

CN (1)