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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tingbo Liu
• Collaborator: Union hospital of Fujian Medical University
• Treatments: Bortezomib; Cytarabine; Fludarabine; Fludarabine phosphate; Vidarabine

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.