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Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects

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ClinicalTrials.gov Identifier: NCT03629873
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
WEI XU, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
This is a single arm, multi-center, open study to evaluating efficacy and safety of Chi-BEAC combining with auto-HSCT to treat aggressive lymphoma Subjects

Condition or disease Intervention/treatment Phase
Lymphoma, Large B-Cell, Diffuse Mantle Cell Lymphoma Peripheral T Cell Lymphoma Double-hit Lymphoma Drug: Chidamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Evaluating Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2020



Intervention Details:
  • Drug: Chidamide
    Chidamide 30mg po d-7、-4、0、3; Carmustine 300mg/m^2 IVD d-6; Etoposide 150mg/m^2/d qd IVD d-5~-2; Cytarabine 150mg/m^2 q12h IVD d-5~-2; Cyclophosphamide 1.0g/m^2/d qd IVD d-5~-2
    Other Names:
    • Carmustine
    • Etoposide
    • Cytarabine
    • Cyclophosphamide
    • Autologous hematopoeitic stem cell transplantation


Primary Outcome Measures :
  1. Progression-free survival rate [ Time Frame: 2 years after transplantation ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years after transplantation ]
  2. Complete remission [ Time Frame: 3 months after transplantation ]
  3. Time of hematopoietic reconstitution [ Time Frame: 15 days, 1 month ]
  4. Non-relapse mortality [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aggressive lymphoma subjects: diffuse large B cell lymphoma confirmed by immunohistochemistry and aaIPI≥3; double-hit lymphoma, as first-line or second-line consolidation therapy; peripheral T-cell lymphoma except ALK-positive type, as first-line or second-line consolidation therapy; mantle cell lymphoma, as first-line or second-line consolidation therapy.
  2. Adequate organ system function including:

    Creatinine clearance rate ≥ 80ml/min and creatinine < 160μmol/L ALT/AST ≤ 2 upper limit of normal Total Bilirubin < 2 upper limit of normal FEV1、FVC and DLCO ≥ 50% predictive value Left ventricular ejection fraction ≥ 50% No Symptomatic arrhythmia

  3. Age 18-60 years, male and female
  4. ECOG score 0-1
  5. Number of neutrophil ≥ 1.5×10^9/L, number of platelet ≥ 70×10^9/L, concentration of hemoglobin ≥ 90g/L, number of CD34+ cells ≥ 2.0×10^6/kg
  6. Expected survival ≥ 12 weeks
  7. Volunteered to participate in this study and signed informed consent

Exclusion Criteria:

  1. Have evidence of CNS lymphoma
  2. Relapse after autologous hematopoietic stem cell transplantation
  3. Active hepatitis B or hepatitis C virus infection
  4. Severe active infection
  5. HIV-infected persons
  6. Liver cirrhosis or hepatic fibrosis
  7. QTc > 500ms
  8. Have mental disorder or unable to sign informed consent
  9. History of drug abuse and intemperance
  10. Women who are pregnant or lactating or have breeding intent
  11. The investigators believe that any increase in the risk of the subject or interference with the results of the trial

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): NCT03629873


Contacts
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Contact: Wei Xu, Ph.D. +86-25-68302182 xuwei10000@hotmail.com

Locations
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China, Jiangsu
Hematological Department, People's Hospital of Jiangsu Province Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Wei Xu, Ph.D.    +86-2568302182    xuwei10000@hotmail.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University

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Responsible Party: WEI XU, Professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03629873     History of Changes
Other Study ID Numbers: JSPH-Chi-BEAC-HSCT
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 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, Mantle-Cell
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Cyclophosphamide
Cytarabine
Carmustine
Etoposide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors