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. Combining rituximab with chemotherapy may kill more cancer cells. PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with rituximab in treating patients who have newly diagnosed mantle cell lymphoma.

Trial Health

100

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline

Completed

Started Sep 2002

Typical duration for phase_2 lymphoma

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

8.8 years study duration

First Submitted

Initial submission to the registry

July 8, 2002

Completed

2 months until next milestone

Study Start

First participant enrolled

September 1, 2002

Completed

5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed

3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

November 1, 2012

Completed

Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

5.2 years

First QC Date

July 8, 2002

Results QC Date

March 5, 2012

Last Update Submit

October 3, 2012

Conditions

Lymphoma

Keywords

stage III mantle cell lymphomastage IV mantle cell lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

Progression-free Survival
Progression-Free Survival (PFS) rate at 1 year. PFS measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is a 50% increase in the sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed if a complete response (confirmed, or unconfirmed) was not previously achieved; appearance of a new lesion/site; unequivocal progression of non-measurable disease; or death due to disease without prior documentation of progression.
assessed after cycle 4, after completion of treatment, then every 3 months until 1 year after registration

Secondary Outcomes (2)

Response
assessed after cycle 4 and after completion of treatment (168 days)
Overall Survival
assessed after cycle 4, after completion of treatment, then every 3 months for 2 years, then every 6 months thereafter until 5 years

Study Arms (1)

Hyper-CVAD + MTX/Ara-C + Rituximab

EXPERIMENTAL

21-day cycles of Hyper-CVAD and high-dose methotrexate/cytarabine are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6. Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubicin 16.6 mg/m\^2/day on days 5-7, vincristine 1.4 mg/m\^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and filgrastim 5 ug/kg on days 8-21. Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m\^2 on day 1, methotrexate 1000 mg/m\^2 over days 2-3, Ara-C 12 g/m\^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21.

Biological: filgrastimBiological: rituximabDrug: cyclophosphamideDrug: cytarabineDrug: dexamethasoneDrug: doxorubicinDrug: leucovorinDrug: methotrexateDrug: vincristine