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LymphomaPhase 2NCT00093769

Bortezomib and Rituximab in Treating Patients With Non-Hodgkin's Lymphoma

A Phase 2 study testing bortezomib + rituximab in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
bortezomib + rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Aug 2004to Aug 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes:
  • Follicular (grade 1, 2, or 3)
  • Marginal zone (extranodal, nodal, or splenic)
  • CD20-positive disease
  • Relapsed or progressive disease after prior anti-neoplastic therapy, as indicated by 1 of the following:
  • New lesions
  • Objective evidence of progression of existing lesions
  • Complete response ≥ 6 months in duration after prior rituximab therapy* NOTE: *For patients who were previously treated with a regimen that included rituximab
  • At least 1 measurable lymph node mass > 1.5 cm in 2 perpendicular dimensions that has not been irradiated OR that has progressed since prior radiotherapy
  • No active CNS lymphoma

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 50-100% OR
  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 50,000/mm^3

Hepatic

  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN

Renal

  • Creatinine ≤ 2 mg/dL OR
  • Creatinine clearance ≥ 30 mL/min

Immunologic

  • No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins or to any component of rituximab, including polysorbate 80 and sodium citrate dihydrate
  • No active systemic infection requiring treatment
  • No history of allergic reaction attributable to compounds containing boron or mannitol

Other

  • No peripheral neuropathy or neuropathic pain ≥ grade 2
  • No other malignancy within the past 5 years except completely resected basal cell or squamous cell skin cancer or an in situ malignancy
  • Previously diagnosed prostate cancer allowed provided the following criteria are met:
  • T1-2a, N0, M0 disease AND Gleason score ≤ 7 AND prostate specific antigen (PSA) ≤ 10 ng/mL before initial therapy
  • Treated with definitive curative therapy (i.e., prostatectomy or radiotherapy) within the past 2 years
  • No clinical evidence of prostate cancer AND undetectable PSA (for prostatectomy patients) or PSA < 1 ng/mL (for patients who did not undergo prostatectomy)
  • No serious medical or psychiatric illness that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • More than 10 weeks since prior radioimmunoconjugates or toxin immunoconjugates (e.g., ibritumomab tiuxetan or iodine I 131 tositumomab)
  • More than 4 weeks since prior rituximab, alemtuzumab, or other unconjugated therapeutic antibody
  • No concurrent prophylactic bone marrow growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa) during course 1 of study therapy

Chemotherapy

  • More than 6 weeks since prior nitrosoureas
  • No concurrent cisplatin

Endocrine therapy

  • No concurrent corticosteroids (e.g., dexamethasone) except prednisone ≤ 15 mg/day or equivalent for adrenal insufficiency

Radiotherapy

  • See Disease Characteristics
  • See Biologic therapy
  • More than 3 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • More than 2 weeks since prior major surgery

Other

  • Recovered from all prior therapy
  • No prior bortezomib
  • More than 3 weeks since prior antineoplastic therapy
  • More than 3 weeks since prior experimental therapy
  • No other concurrent antineoplastic therapy
  • No other concurrent investigational agents
  • Concurrent participation in a non-treatment study allowed provided it does not interfere with participation in this study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: A Phase II Study of VELCADE With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving bortezomib together with rituximab may kill more cancer cells.

PURPOSE: This randomized phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the response rate (complete response [CR], CR-unconfirmed [CRu], and partial response [PR]) in patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma treated with bortezomib and rituximab.

Secondary

  • Determine the response rate (CR, CRu, and PR) at the first disease response evaluation in patients treated with this regimen.
  • Determine the overall CR rate (CR and CRu) in patients treated with this regimen.
  • Determine the time to progression in patients treated with this regimen.
  • Determine the duration of response in patients treated with this regimen.
  • Determine the time to best response in patients treated with this regimen.
  • Determine the safety and tolerability of this regimen in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, Karnofsky performance status (< 70% vs ≥ 70%), lactic dehydrogenase level (normal vs > upper limit of normal), age (18 to 60 years vs > 60 years), and lymphoma subtype (follicular vs marginal zone). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients also receive rituximab IV on days 1, 8, and 15 of course 1 only and on day 1 of course 2 only. Treatment with repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15 and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 only. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients in either arm may crossover to the other arm if treatment is found to be ineffective.

Patients are followed at 30 days and then every 12 weeks thereafter.

PROJECTED ACCRUAL: A total of 24-66 patients (12-33 per treatment arm) will be accrued for this study within 1 year.

Conditions
Lymphoma
Being tested
bortezomib + rituximab
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent marginal zone lymphoma, splenic marginal zone lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bortezomib + rituximabDrug

    Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients also receive rituximab IV on days 1, 8, and 15 of course 1 only and on day 1 of course 2 only. Treatment with repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.

    • Arm II: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15 and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 only. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

    Patients in either arm may crossover to the other arm if treatment is found to be ineffective.

Study groups in NCT00093769
Study groupRoleWhat they receive
bortezomib + rituximabExperimentalArm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients also receive rituximab IV on days 1, 8, and 15 of course 1 only and on day 1 of course 2 only. Treatment with repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15 and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 only. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients in either arm may crossover to the other arm if treatment is found to be ineffective.
Receives: Drug: bortezomib + rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate (complete response [CR], CR-unconfirmed [CRu], and partial response [PR])

    Measured: 12 weeks

Secondary outcomes (3)
  1. Response rate (CR, CRu, and PR) at the first disease response evaluation

    Measured: 12 weeks

  2. Overall CR rate (CR and CRu)

    Measured: 12 weeks

  3. Safety and tolerability

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2004 (estimated)
  2. Study startAug 2004
  3. Primary completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00093769
Sponsor's protocol ID
CDR0000390235
Other IDs
UCLA-0401054-01, MILLENNIUM-M34103-061
Status last verified
Oct 2012
First submitted
6 Oct 2004
Last updated
4 Oct 2012
Results posted
No

Publications

  • de Vos S, Goy A, Dakhil SR, Saleh MN, McLaughlin P, Belt R, Flowers CR, Knapp M, Hart L, Patel-Donnelly D, Glenn M, Gregory SA, Holladay C, Zhang T, Boral AL. Multicenter randomized phase II study of weekly or twice-weekly bortezomib plus rituximab in patients with relapsed or refractory follicular or marginal-zone B-cell lymphoma. J Clin Oncol. 2009 Oct 20;27(30):5023-30. doi: 10.1200/JCO.2008.17.7980. Epub 2009 Sep 21.

    PubMed 19770386

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib + rituximab in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (complete response [CR], CR-unconfirmed [CRu], and partial response [PR]) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00093769, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.

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