Mantle Cell Lymphoma Recurrent Clinical Trial
Official title:
Phase 1 and 2 Study of Combination Treatment of Bortezomib, Fludarabine and Cyclophosphamide in Patients With Recurrent Mantle Cell Lymphoma
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.
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.
This study consists of three phases: screening/baseline phase, treatment phase and follow-up
phase after the end of treatment.
At screening/baseline phase, investigators obtain informed consent form, check the
inclusion/exclusion criteria and then collect the following data: demographics, medical
history data, vital signs, ECG, MRI/CT/B-ultrasound/X-ray examinations, physical
examination, laboratory examinations, pregnancy test (only female) and bone marrow biopsy
and aspiration. Pathological diagnosis of mantle cell lymphoma should be established by
lymph node biopsy or other tumor histopathological examination and immunophenotyping. At the
same time, ECOG-performance status, Fact/GOG-Ntx questionnaire and NF-κB activity will be
assessed.
During treatment period, patients will be treated with bortezomib, fludarabine and
cyclophosphamide in a 28-day cycle. Patients achieve complete response (CR) or partial
response (PR) can receive up to six cycles of VF (C) treatment, while those continue stable
disease (SD) will be stopped after 4-cycle treatment and those with progressive disease (PD)
will also be stopped after 2-cycle treatment. Due to adverse events, patients may receive
reductions or deviate from the intended dose and duration of VF (C) treatment. These
adjustments must be in accordance with the regulations in the protocol about the dose and
time adjustment.
Maximum tolerated dose (MTD) of cyclophosphamide will be determined in accordance with the
standard "3+3" method, testing three dose levels, 150mg/m2, 200mg/m2 and 250mg/m2.
Cyclophosphamide dose escalation test will be conducted in the first cycle, with every three
patients in a group. Patients' enrollment will be competed among different sites, but
further step should be taken only after the 3 patients in one group complete the first
cycle, their efficacy and safety have been completely evaluated, and the notification of
going to next step by a CRO company. Subjects involved in the cyclophosphamide dose
escalation test will continue initial cyclophosphamide dose during the entire study, except
for possible dose adjustment determined by investigators due to DLT. After ascertaining MTD,
new patients will be administrated with cyclophosphamide at the MTD. According to the dose
escalation diagram, up to 18 patients will be involved in dose escalation phase. Subjects
who discontinue the treatment due to causes other than DLT in the first cycle should be
replaced by new participants to enter dose escalation test. DLT is defined as: a grade 4
neutropenia lasting longer than 7 days, a grade 4 thrombocytopenia, a neutropenic fever, or
a grade 3 or above non-hematological toxicity (except for nausea, vomiting and alopecia); a
grade 3 or above nausea, vomiting or diarrhea is considered as DLT only if still observed
after treatment. Please refer to dose escalation diagram to conduct dose escalation trial.
Subjects will be followed up for 24 weeks after the end of chemotherapy. In this study, the
primary efficacy endpoints are maximum tolerated dose (MTD) of cyclophosphamide in
combination treatment with bortezomib and fludarabine, complete response rate (CR + CRu),
overall response rate (ORR). Main indicators will be evaluated every 2 cycles in the
treatment period and every 12 weeks in follow-up period.
Concomitant medications within 2 week before enrollment and during the study process need to
be documented. All adverse events will be reported from the time a signed and dated informed
consent form is obtained until 30 days following the last dose of study drug.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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