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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mantle Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

Bortezomib

Intervention Type DRUG

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

Fludarabine

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Interventions

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Bortezomib

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

Intervention Type DRUG

Fludarabine

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

Intervention Type DRUG

Cytarabine

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

Intervention Type DRUG

Other Intervention Names

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Bortezomib (PS-341) NSC 118218 Cytosar-U Cytosine Arabinoside

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No