Compared the Efficacy and Safety of CDOP Combined With Chidamide and CDOP in de Novo Peripheral T Cell Lymphoma Patients

NCT03023358 | Unknown Phase 3 DMC

• 1 other identifier: CDOP201602
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

The prognosis for Peripheral T cell lymphomas (PTCL) remains poor in comparison to B cell NHL. This is largely due to lower response rates and less durable responses to standard combination chemotherapy regimens such as CHOP. Whether CDOP plus Chidamide can improve the prognosis for PTCL.

Conditions

Peripheral T Cell Lymphoma

Keywords

peripheral T cell lymphoma

Outcome Measures

Primary Outcomes (1)

• complete remission rate

  3 year

Secondary Outcomes (3)

• disease free survival

  3 years

• overall survival

  3 years

• time to progression

  3 years

Study Arms (2)

chidamide regimen

EXPERIMENTAL

patients receive chidamide (30mg twice every week) po, cyclophosphamide (750mg/m2) iv on day 1, liposomal doxorubicin (30mg/m2) iv on day 1, vincristine (1.4mg/m2, max to 2mg) iv on day 1 and prednisone (100mg/d) po on day 1-5.

Drug: chidamide; Drug: cyclophosphamide; Drug: liposomal doxorubicin; Drug: vincristine; Drug: prednisone

CDOP regimen

ACTIVE COMPARATOR

patients receive cyclophosphamide (750mg/m2) iv on day 1, liposomal doxorubicin (30mg/m2) iv on day 1, vincristine (1.4mg/m2, max to 2mg) iv on day 1 and prednisone (100mg/d) po on day 1-5.

Drug: cyclophosphamide; Drug: liposomal doxorubicin; Drug: vincristine; Drug: prednisone

Interventions

chidamide DRUG

30mg po twice a week

Also known as: epidaza

chidamide regimen

cyclophosphamide DRUG

750mg/m2 iv on day 1

CDOP regimen; chidamide regimen

liposomal doxorubicin DRUG

30mg/m2 iv on day 1

CDOP regimen; chidamide regimen

vincristine DRUG

1.4mg/m2 iv on day 1

CDOP regimen; chidamide regimen

prednisone DRUG

100mg/d po on day 1-5

CDOP regimen; chidamide regimen

Eligibility Criteria

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

You may qualify if:

• Patients aged over 18 years are eligible.
• Patients must be diagnosed of de love peripheral T cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, ALK negative anapestic large cell lymphoma and enteropathy-associated T cell lymphoma). Patients must be chemo-naive.
• ECOG PS of 0, 1, 2 at screening.
• Serum biochemical values with the following limit: - creatine \</= 2.0 mg/dl, - total bilirubin \</= 2.0mg/dl, - transaminases (SG PT) \</= 3X ULN
• Ability to understand an provide signed informed consent.

You may not qualify if:

• Presence of active systemic infection.
• Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
• Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
• Patients whom the investigators considered were not applicable.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Ru Feng

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

• Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. doi: 10.1093/annonc/mdv237. Epub 2015 Jun 23.

  PMID: 26105599 BACKGROUND

Related Links

• Nan fang Hospital, the Southern Medical University

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Cyclophosphamide; liposomal doxorubicin; Vincristine; Prednisone

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

Study Officials

• Ru Feng, M.D.

  Department of Hematology Nanfang Hospital, The Southern Medical University

  STUDY CHAIR

Central Study Contacts

Ru Feng, M.D.

CONTACT

+86 13725119762; ruth1626@hotmail.com

Qi Wei, M.D.

CONTACT

+86 13427564102; sinbad37@126.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: Professor

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: January 18, 2017
• Study Start: February 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)