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The Efficacy and Safety of Bortezomib Combined With Fludarabine and Cytarabine Treatment for Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016988
Recruitment Status : Not yet recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Union hospital of Fujian Medical University
Information provided by (Responsible Party):
Tingbo Liu, Fujian Medical University

Brief Summary:
Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma (NHL) and shows poor survival. This study to evaluate the efficacy and safety of Bortezomib combined with Fludarabine and Cytarabine treatment in the naive and relapsed MCL who are not eligible for high dose therapy and transplantation.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: Bortezomib Drug: Fludarabine Drug: Cytarabine Phase 2

Detailed Description:

The eligibility criteria were pathologically confirmed, previously untreated MCL or relapsed MCL as defined by the World Health Organization classification; age≥18 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l), hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); normal coagulation function and electrocardiogram results. Stage was defined according to the Ann Arbor system.

The Fujian Medical University Union Hospital approved this study before subjects were enrolled.

Treatment dosages were as follows:

days 1,4,8,and 11 subcutaneous infusion of 1.3mg/m2 Bortezomib. Days 1-3 intravenous infusion 25mg/m2 Fludarabine. Days 1-3 intravenous infusion of 500mg/m2 Cytarabine. The regimen was repeated every 28 days for a maximum of six cycles.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bortezomib Combined With Fludarabine and Cytarabine for Mantle Cell Lymphoma Patients:a Single Arm, Open-labelled, Phase 2 Study
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Bortezomib,Fludarabine and Cytarabine
Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11; Fludarabine(F) 25mg/m2, intravenously day 1-3; Cytarabine(A) 500mg/m2 for 3 days(day1-3).
Drug: Bortezomib
Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11;
Other Name: Bortezomib (PS-341)

Drug: Fludarabine
Fludarabine(F) 25mg/m2, intravenously day 1-3;
Other Name: NSC 118218

Drug: Cytarabine
Cytarabine(A) 500mg/m2 for 3 days(day1-3)
Other Names:
  • Cytosar-U
  • Cytosine Arabinoside




Primary Outcome Measures :
  1. Progress-free survival [ Time Frame: Follow-up to 36 months ]
    Interval from registration to progression or death from any cause


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to 36 months ]
    Lugano classification



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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:

Inclusion Criteria:

  1. pathologically confirmed, previously untreated MCL or relapsed MCL as defined by the World Health Organization classification;
  2. age≥18 years;
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  4. adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l),
  5. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal),
  6. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);
  7. normal coagulation function and electrocardiogram results.
  8. willingness to provide written informed consent.

Exclusion Criteria:

  1. MCL patients who do NOT response or are refractory to preview treatment.
  2. Who do NOT sign the consent form.
  3. whose life expectation is less than 6 months.
Additional Information:
Publications of Results:
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Responsible Party: Tingbo Liu, Professor of medicine, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03016988    
Other Study ID Numbers: Fujian Medical University
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Tingbo Liu, Fujian Medical University:
Mantle cell lymphoma
Bortezomib
Fludarabine
Cytarabine
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cytarabine
Fludarabine
Bortezomib
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents