Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline

Completed

Started Nov 2002

Typical duration for phase_2 lymphoma

Geographic Reach

1 country

10 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

7.1 years study duration

First Submitted

Initial submission to the registry

February 14, 2002

Completed

9 months until next milestone

Study Start

First participant enrolled

November 19, 2002

Completed

2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2005

Completed

4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2009

Completed

Last Updated

August 4, 2023

Status Verified

April 1, 2020

Enrollment Period

2.7 years

First QC Date

February 14, 2002

Last Update Submit

August 3, 2023

Conditions

Lymphoma

Keywords

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

Interventions

bortezomibDRUG

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed relapsed or untreated mantle cell lymphoma * No refractory disease defined as progression while on chemotherapy or within 1 month after completion of chemotherapy * At least 1 bidimensionally measurable disease site\* * Lymph nodes at least 1.5 cm by 1.5 cm by spiral CT scan OR * Non-nodal lesions (e.g., skin lesion or nodules) at least 1 cm by 1 cm by MRI, CT scan, or physical exam NOTE: \*Bone lesions are not considered bidimensionally measurable disease * No pre-existing ascites or pleural effusion * No known CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST or ALT no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular * LVEF at least 45% by echocardiogram or MUGA Pulmonary * No pre-existing shortness of breath greater than grade 1 Other: * No uncontrolled bacterial, fungal, or viral infections * No pre-existing edema greater than grade 1 * No pre-existing neuropathy greater than grade 1 * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No other serious illness or medical condition that would preclude study compliance * No geographical conditions that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * Prior rituximab allowed * No prior radioactive monoclonal antibody therapy Chemotherapy: * See Disease Characteristics * No prior high-dose chemotherapy with stem cell transplantation * No more than 2 prior systemic chemotherapy regimens * Same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens * No prior flavopiridol * At least 6 weeks since prior chemotherapy * No concurrent cytotoxic chemotherapy Endocrine therapy: * No concurrent corticosteroids Radiotherapy: * No prior radiotherapy to 25% or more of functioning bone marrow * At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered * No concurrent radiotherapy to the sole site of measurable disease Surgery: * At least 2 weeks since prior major surgery Other: * No prior investigational therapy * No other concurrent anticancer therapy * No other concurrent investigational anticancer therapy

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

Sponsors & Collaborators

NCIC Clinical Trials Grouplead

Study Sites (10)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, K7L 5P9, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Related Publications (3)

Belch A, Kouroukis CT, Crump M, Sehn L, Gascoyne RD, Klasa R, Powers J, Wright J, Eisenhauer EA. A phase II study of bortezomib in mantle cell lymphoma: the National Cancer Institute of Canada Clinical Trials Group trial IND.150. Ann Oncol. 2007 Jan;18(1):116-121. doi: 10.1093/annonc/mdl316. Epub 2006 Sep 13.
PMID: 16971665RESULT
Belch A, Kouroukis CT, Crump M: Phase II trial of bortezomib in mantle cell lymphoma. [Abstract] Blood 104(11): A-608, 2004.
RESULT
Assouline S, Belch A, Sehn L, et al.: A phase II study of bortezomib in patients with mantle cell lymphoma. [Abstract] Blood 102 (11 Pt 1): A-3358, 2003.
RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Mantle-Cell

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Andrew R. Belch, MD
Cross Cancer Institute at University of Alberta
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: NETWORK
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

November 19, 2002

Primary Completion

July 21, 2005

Study Completion

December 21, 2009

Last Updated

August 4, 2023

Record last verified: 2020-04

Data Sharing

IPD Sharing: Will not share

Locations

CA(10)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (10)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations