Combination of Bortezomib, Fludarabine and Cyclophosphamide Treat Recurrent Mantle Cell Lymphoma

• Status: Unknown status
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, single arm, open-label, prospective IIS study, which will enroll 40 recurrent MCL patients.The aim is to evaluate the efficacy and safety of bortezomib, fludarabine and cyclophosphamide treatment and also analyze the relationship between NF-kB activity and efficacy of bortezomib treatment and whether NF-kB activity can predict MCL progression.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Beijing Cancer Hospital; Fudan University; Jiangsu Cancer Institute & Hospital; Ruijin Hospital; Tianjin Medical University Cancer Institute and Hospital; West China Hospital; Zhejiang University
• Treatments: Bortezomib; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

Inclusion Criteria:

• Male or female patients 18 years or older;

• Histologically confirmed MCL (Initial diagnosis in hospitals other than sites must be reconfirmed;

• Recurrent patients after first-line or second-line chemotherapy;

• At least including the following characteristic immunophenotype confirmed by immunohistochemistry: CD 20+, CD5+ and cyclin D1+;

• At least 1 measurable site of tumor（long diameter > 2.0 cm by physical examination or > 1.5cm on CT;

• No involvement of central nervous system;

• ECOG performance status ≤ 2，life expectancy>6 months;

• Within 14 days before enrollment，WBC > 3×10^9/L，neutrophils > 1.5×10^9/L，platelets > 75×10^9/L;

• ALT ≤ 2 × upper limit of normal (ULN)，AST ≤ 2×ULN，total bilirubin ≤ 2×ULN，serum creatinine ≤ 1.5×ULN，calculated creatinine clearance > 50ml/min;

• Female patients must be post menopausal, surgically sterile, or practicing an effective method of birth control;

• Male patients must agree to use an acceptable method of contraception for the duration of the study;

• All patients must have signed an informed consent document indicating that they understand the purpose and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

• Peripheral neuropathy or neuropathic pain of grade 2 or worse according to CTC AE 3.0;

• Prior treatment with bortezomib;

• Diagnosed as a malignancy other than MCL（Patients with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded;

• Any experimental or anti-cancer therapy within 4 weeks before the first dose of study drug (including rituximab, alemtuzumab or unconjugated therapeutic antibodies, radiation therapy, etc.);

• Fludarabine resistance or intolerance，exposure to fludarabine within 6 months before screening；History of allergic reaction to compounds containing boron, mannitol, fludarabine or cyclophosphamide;

• Patients with known diagnosis of active systemic infection, HIV or active hepatitis B (carriers of hepatitis B are permitted to enter study);

• Serious medical (e.g., cardiac failure [New York Heart Association: NYHA Class III or IV, or left ventricular ejection fraction: LVEF < 50%], active peptic ulceration, or uncontrolled diabetes mellitus) or psychiatric illness likely to interfere with participation in this clinical study;

• Pregnancy or lactation;

• Female or male patients of child-bearing potential who will not use adequate contraception during the course of the study;

• Other condition likely to interfere with participation in this clinical study.