NCT00053092

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without rituximab in treating mantle cell lymphoma. PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell lymphoma.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline
Completed

Started Oct 2002

Typical duration for phase_2 lymphoma

Geographic Reach
2 countries

2 active sites

Status
completed

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

October 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2003

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

December 18, 2013

Status Verified

June 1, 2007

First QC Date

January 27, 2003

Last Update Submit

December 17, 2013

Conditions

Lymphoma

Keywords

contiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomastage I mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphoma

Outcome Measures

Primary Outcomes (4)

  • Response rate

  • Time to disease progression

  • Toxicity

  • Overall survival

Interventions

rituximabBIOLOGICAL
cyclophosphamideDRUG
fludarabine phosphateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed previously untreated mantle cell lymphoma requiring therapy * Any stage PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * At least 3 months Hematopoietic * Not specified Hepatic * Bilirubin no greater than 2.5 times upper limit of normal (ULN)\^\* * Alkaline phosphatase no greater than 2.5 times ULN\^\* * Hepatitis B and hepatitis C negative NOTE: \*Unless related to lymphoma Renal * Creatinine no greater than 2.5 times ULN\^\* NOTE: \*Unless related to lymphoma Other * No other malignancy within the past 5 years except non-melanoma skin cancer or curatively resected carcinoma in situ of the cervix * No prior psychological illness or condition that would preclude study compliance * No known hypersensitivity to murine proteins * No concurrent uncontrolled medical conditions * No other illness that would severely limit life expectancy * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Related Publications (1)

  • Eve HE, Linch D, Qian W, Ross M, Seymour JF, Smith P, Stevens L, Rule SA. Toxicity of fludarabine and cyclophosphamide with or without rituximab as initial therapy for patients with previously untreated mantle cell lymphoma: results of a randomised phase II study. Leuk Lymphoma. 2009 Feb;50(2):211-5. doi: 10.1080/10428190802688509.

    PMID: 19197729RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Mantle-Cell

Interventions

RituximabCyclophosphamidefludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Simon Rule, MD

    Derriford Hospital

    STUDY CHAIR

  • John Seymour, MD

    Peter MacCallum Cancer Centre, Australia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2003

First Posted

January 28, 2003

Study Start

October 1, 2002

Study Completion

February 1, 2009

Last Updated

December 18, 2013

Record last verified: 2007-06

Locations

AU(1)GB(1)