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

Mantle Cell Lymphoma Clinical Trial

Official title:

Bortezomib Combined With Fludarabine and Cytarabine for Mantle Cell Lymphoma Patients：a Single Arm, Open-labelled, Phase 2 Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03016988
• Other study ID #: Fujian Medical University
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 11, 2016
• Last updated: January 9, 2017
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: August 2016
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Fujian Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• Bortezomib
Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11;
• Fludarabine
Fludarabine(F) 25mg/m2, intravenously day 1-3;
• Cytarabine
Cytarabine(A) 500mg/m2 for 3 days(day1-3)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tingbo Liu	Union hospital of Fujian Medical University

References & Publications (1)

Cheah CY, Seymour JF, Wang ML. Mantle Cell Lymphoma. J Clin Oncol. 2016 Apr 10;34(11):1256-69. doi: 10.1200/JCO.2015.63.5904. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-free survival	Interval from registration to progression or death from any cause	Follow-up to 36 months	No
Secondary	Overall response rate	Lugano classification	Up to 36 months	No

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