NCT01322776

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 25, 2011

Status Verified

March 1, 2011

Enrollment Period

2.6 years

First QC Date

March 24, 2011

Last Update Submit

March 24, 2011

Conditions

Mantle Cell Lymphoma Recurrent

Keywords

Mantle Cell LymphomaRecurrentBortezomibCombination Treatment

Outcome Measures

Primary Outcomes (1)

  • Clinical efficacy will be assessed according to the CT scan and bone marrow aspirate and biopsy

    The International Working Group (IWG) published the guidelines for response criteria for lymphoma in 1999. These response criteria are based on the reduction in the size of the enlarged lymph node as measured by CT scan and the extent of bone marrow involvement that is determined by bone marrow aspirate and biopsy.

    2cycle,28-day/cycle

Secondary Outcomes (1)

  • Maximum Tolerated Dose（MTD）of Cyclophosphamide

    6 months

Study Arms (1)

Bortezomib,Fludarabine,Cyclophosphamide

EXPERIMENTAL
Drug: Combination of Bortezomib, Fludarabine and Cyclophosphamide

Interventions

Combination of Bortezomib, Fludarabine and CyclophosphamideDRUG

bortezomib 1.3mg/m\^2 i.v. on days 1, 4, 8 and 11 of each 28-day cycle fludarabine 25mg/m\^2 i.v. on days 1\~3 of each 28-day cycle cyclophosphamide i.v. on days 1\~2 of each 28-day cycle

Bortezomib,Fludarabine,Cyclophosphamide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SunYat-sen University Cancer Centre

Guangzhou, Guangdong, China

RECRUITING

Related Publications (1)

  • Wang XX, Gao Y, Jin J, Cao JN, Feng JF, Wang HQ, Zhang HL, Cai QQ, Li ZM, Jiang WQ, Huang HQ; Lymphoma Committee, Chinese Anti-Cancer Association (CACA). Bortezomib in combination with fludarabine plus cyclophosphamide for patients with relapsed or refractory mantle-cell lymphoma: results of the LYM-4003 study. Ann Hematol. 2021 Dec;100(12):2961-2968. doi: 10.1007/s00277-021-04619-4. Epub 2021 Jul 31.

    PMID: 34331111DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-CellRecurrence

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Central Study Contacts

Huiqiang Huang

CONTACT

huanghq@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 25, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 25, 2011

Record last verified: 2011-03

Locations

CN(1)