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

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ClinicalTrials.gov Identifier: NCT03023358
Recruitment Status : Unknown
Verified January 2017 by Ru Feng, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Not yet recruiting
First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Ru Feng, Nanfang Hospital of Southern Medical University

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.

Condition or disease Intervention/treatment Phase
Peripheral T Cell Lymphoma Drug: chidamide Drug: cyclophosphamide Drug: liposomal doxorubicin Drug: vincristine Drug: prednisone Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compared the Efficacy and Safety of CDOP Combined With Chidamide and CDOP in de Novo Peripheral T Cell Lymphoma Patients
Study Start Date : February 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: chidamide regimen
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
30mg po twice a week
Other Name: epidaza

Drug: cyclophosphamide
750mg/m2 iv on day 1

Drug: liposomal doxorubicin
30mg/m2 iv on day 1

Drug: vincristine
1.4mg/m2 iv on day 1

Drug: prednisone
100mg/d po on day 1-5

Active Comparator: CDOP regimen
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
750mg/m2 iv on day 1

Drug: liposomal doxorubicin
30mg/m2 iv on day 1

Drug: vincristine
1.4mg/m2 iv on day 1

Drug: prednisone
100mg/d po on day 1-5




Primary Outcome Measures :
  1. complete remission rate [ Time Frame: 3 year ]

Secondary Outcome Measures :
  1. disease free survival [ Time Frame: 3 years ]
  2. overall survival [ Time Frame: 3 years ]
  3. time to progression [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT03023358


Contacts
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Contact: Ru Feng, M.D. +86 13725119762 ext 510515 ruth1626@hotmail.com
Contact: Qi Wei, M.D. +86 13427564102 ext 510515 sinbad37@126.com

Locations
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China, Guangdong
Ru Feng Not yet recruiting
Guangzhou, Guangdong, China, 510515
Contact: Ru Feng, M.D.    +86 13725119762    ruth1626@hotmail.com   
Contact: Qi Wei, M.D.    +86 13427564102    sinbad37@126.com   
Principal Investigator: Ru Feng, M.D.         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Study Chair: Ru Feng, M.D. Department of Hematology Nanfang Hospital, The Southern Medical University

Additional Information:
Publications:
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Responsible Party: Ru Feng, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03023358     History of Changes
Other Study ID Numbers: CDOP201602
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ru Feng, Nanfang Hospital of Southern Medical University:
peripheral T cell lymphoma
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
Prednisone
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
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