NCT00064116

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 whether combination chemotherapy is more effective with or without rituximab in treating patients with non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
824

participants targeted

Target at P75+ for phase_3 lymphoma

Timeline
Completed

Started May 2001

Longer than P75 for phase_3 lymphoma

Geographic Reach
1 country

25 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

May 8, 2001

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2003

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2014

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

9.6 years

First QC Date

July 8, 2003

Last Update Submit

March 30, 2020

Conditions

Lymphoma

Keywords

stage I adult diffuse large cell lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Time to treatment failure (TTF) at 3 years

    3 years

Secondary Outcomes (7)

  • Complete remission rate after completion of treatment

    3 years

  • Overall survival at 3 years

    3 years

  • Tumor control measured by TTF with non-tumor events censored at 3 years

    3 years

  • Disease-free survival (DFS) measured by TTF after an event during and directly after treatment at 3 years

    3 years

  • Progression rate determined by dividing the number of patients with disease progression by number of patients with evaluable outcome at 3 years

    3 years

  • +2 more secondary outcomes

Study Arms (2)

Arm A: CHOP-21

ACTIVE COMPARATOR

Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle: day 22 Total number of cycles 6

Drug: CHOP regimen

Arm B: CHOP-21 + Rituximab

ACTIVE COMPARATOR

Rituximab 375 mg/m² i.v. day 1\* Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6

Biological: rituximabDrug: CHOP regimen

Interventions

rituximabBIOLOGICAL

Rituximab 375 mg/m² i.v. day 1

Arm B: CHOP-21 + Rituximab
CHOP regimenDRUG

Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6

Arm A: CHOP-21Arm B: CHOP-21 + Rituximab

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL classification * Diagnosed within the past 6 weeks * CD20+ disease * Ann Arbor stage II, III, or IV disease or stage I bulky disease * International Prognostic Index (IPI) score of 0 or 1 * Score 0 defined by all of the following: * Stage I or II disease * ECOG performance status of 0 or 1 * Lactic dehydrogenase (LDH) no greater than upper limit of normal (ULN) * Score 1 defined by 1 of the following: * Stage I or II disease; ECOG performance status of 0 or 1; and LDH greater than ULN * Stage I or II disease; ECOG performance status 2 or 3; and LDH no greater than ULN * Stage III or IV disease; ECOG performance status 0 or 1; and LDH no greater than ULN * Previously untreated disease * Mediastinal B-cell lymphoma allowed * No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies * No transformed lymphoma * No primary CNS lymphoma * No primary gastrointestinal (MALT) lymphoma * No post-transplant lymphoproliferative disorder PATIENT CHARACTERISTICS: Age * 18 to 60 Performance status * See Disease Characteristics * ECOG 0-3 Life expectancy * At least 3 months Hematopoietic * Not specified Hepatic * Bilirubin no greater than 2.0 mg/dL\* * Transaminases no greater than 3 times normal\* * No active chronic hepatitis B or C infection NOTE: \*Unless related to lymphoma Renal * Creatinine no greater than 2 times normal\* NOTE: \*Unless related to lymphoma Cardiovascular * No myocardial infarction within the past 6 months * No uncompensated heart failure * No dilatative cardiomyopathy * No coronary heart disease with ST segment depression on ECG * No severe uncompensated hypertension Pulmonary * No chronic lung disease with hypoxemia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No known allergic reactions against foreign proteins * No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No concurrent disease that would preclude study treatment * No active infections requiring systemic antibiotics or antiviral medications * No severe uncompensated diabetes mellitus * No clinical signs of cerebral dysfunction * No severe psychiatric disease PRIOR CONCURRENT THERAPY: Biologic therapy * No prior murine antibodies Chemotherapy * No other concurrent anticancer chemotherapy Endocrine therapy * Not specified Radiotherapy * No concurrent response-adapted (slow response or unconfirmed complete response) radiotherapy Surgery * Not specified Other * No prior lymphoma-specific treatment * More than 12 weeks since prior participation in another clinical trial * No prior participation in this study * No other concurrent study medication

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

Sponsors & Collaborators

Study Sites (25)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, AIB 3V6, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Niagara Health System

St. Catharines, Ontario, L2R 7C6, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Univ. Health Network-The Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Trillium Health Centre - West Toronto

Toronto, Ontario, M9C 1A5, Canada

Location

PEI Cancer Treatment Centre,Queen Elizabeth Hospital

Charlottetown, Prince Edward Island, C1A 8T5, Canada

Location

Hopital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

CHA-Hopital Du St-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (2)

  • Pfreundschuh M, Ho AD, Cavallin-Stahl E, Wolf M, Pettengell R, Vasova I, Belch A, Walewski J, Zinzani PL, Mingrone W, Kvaloy S, Shpilberg O, Jaeger U, Hansen M, Corrado C, Scheliga A, Loeffler M, Kuhnt E; MabThera International Trial (MInT) Group. Prognostic significance of maximum tumour (bulk) diameter in young patients with good-prognosis diffuse large-B-cell lymphoma treated with CHOP-like chemotherapy with or without rituximab: an exploratory analysis of the MabThera International Trial Group (MInT) study. Lancet Oncol. 2008 May;9(5):435-44. doi: 10.1016/S1470-2045(08)70078-0. Epub 2008 Apr 8.

    PMID: 18400558RESULT

  • Pfreundschuh M, Trumper L, Osterborg A, Pettengell R, Trneny M, Imrie K, Ma D, Gill D, Walewski J, Zinzani PL, Stahel R, Kvaloy S, Shpilberg O, Jaeger U, Hansen M, Lehtinen T, Lopez-Guillermo A, Corrado C, Scheliga A, Milpied N, Mendila M, Rashford M, Kuhnt E, Loeffler M; MabThera International Trial Group. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006 May;7(5):379-91. doi: 10.1016/S1470-2045(06)70664-7.

    PMID: 16648042RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, Diffuse

Interventions

RituximabVAP-cyclo protocol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Kevin Imrie, MD

    Toronto Sunnybrook Regional Cancer Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 9, 2003

Study Start

May 8, 2001

Primary Completion

December 1, 2010

Study Completion

January 16, 2014

Last Updated

April 1, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(25)