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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03016988

Enrollment

Registered

2017-01-11

Start date

2017-01-31

Completion date

2020-12-31

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle Cell Lymphoma

Keywords

Mantle cell lymphoma, Bortezomib, Fludarabine, Cytarabine

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.

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.

Interventions

DRUGBortezomib

Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11;

DRUGFludarabine

Fludarabine(F) 25mg/m2, intravenously day 1-3;

DRUGCytarabine

Cytarabine(A) 500mg/m2 for 3 days(day1-3)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Progress-free survival	Follow-up to 36 months	Interval from registration to progression or death from any cause

Secondary

Measure	Time frame	Description
Overall response rate	Up to 36 months	Lugano classification

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026