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Diffuse Large B-Cell LymphomaPhase 2NCT01040871

Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

A Phase 2 study testing VELCADE, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by Millennium Pharmaceuticals, Inc. at 1 site in Belgium.

Completed

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

Official record
Search all trials

Trial summary

This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
VELCADE, Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
1 siteBelgium
Study dates
Jan 2010to Aug 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Male or female patients 18 years or older.
  • Newly Diagnosed non-GCB subtype of DLBCL (Stage II, III or IV).
  • At least 1 measurable site of disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; and have a negative pregnancy test at screening.
  • Male subjects must agree to use a double barrier method of birth control

Who cannot join

  • Prior treatment with VELCADE.
  • Prior extended radiotherapy or chemotherapy for lymphoma
  • More than 150 mg/m2 of prior doxorubicin
  • Major surgery within 3 weeks of study.
  • Peripheral neuropathy or neuralgia of Grade 2 or worse.
  • Active CNS lymphoma
Show all 14Show fewer
  • Diagnosed or treated for a malignancy other than NHL, with some exceptions
  • Pregnant or breast feeding
  • Active systemic infection
  • Documented of suspected human immunodeficiency virus (HIV)/AIDS
  • Uncontrolled or severe cardiovascular disease
  • Known allergies, hypersensitivity or intolerance to study drugs
  • Serious medical condition that could interfere with study
  • Concurrent treatment with another investigational agent

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie

    Ghent

Other trials in Belgium

About this study

Official title: A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)

Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • VELCADEDrug

    VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles.

  • RituximabDrug

    Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

  • CyclophosphamideDrug

    Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

  • DoxorubicinDrug

    Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

  • PrednisoneDrug

    Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles

  • VincristineDrug

    Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Study groups in NCT01040871
Study groupRoleWhat they receive
VR-CAPExperimentalVR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.
Receives: Drug: VELCADE; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone
R-CHOPActive comparatorR-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Vincristine

What is being measured

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

  1. Complete Response (CR) Rate

    Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.

    1. Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
    2. PET scan was negative.
    3. The spleen and/or liver, if enlarged before therapy on the basis of physical examination or CT scan, was not palpable on physical examination and was considered normal size by imaging studies; all splenic and hepatic nodules related to lymphomas disappeared.
    4. If bone marrow was involved before treatment, the infiltrate cleared on repeated bone marrow biopsy.
    5. No new sites of disease were detected.

    Measured: 6 cycles

Secondary outcomes (7)

  1. Overall Response Rate

    Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.

    Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses.

    Measured: 6 cycles

  2. Rate of Durable Response

    Proportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.

    Measured: Median follow up approx. 12 months

  3. Rate of Durable Complete Response

    Proportion of subjects who achieved a CR with duration of at least 6 months

    Measured: Median follow up approx 12 months

  4. Subsequent Anti-lymphoma Therapy Rate at 1-year

    Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive.

    Measured: 1 year

  5. Progression-free Survival (PFS)Rate at 1-year

    Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death.

    Measured: 1 year

  6. Overall Survival Rate at 1-year

    Kaplan-meier estimate of overall survival at 1-year measured from date of randomization.

    Measured: 1 year

  7. Change in Fatigue and Patient Utility Scores

    Measured: 18-24 months

Timeline

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

  1. First posted30 Dec 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2012
  4. Study completionAug 2012

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01040871
Sponsor's protocol ID
26866138-LYM-2034
Status last verified
Dec 2013
First submitted
29 Dec 2009
Last updated
13 Jan 2014
Data monitoring committee
No

Publications

  • Offner F, Samoilova O, Osmanov E, Eom HS, Topp MS, Raposo J, Pavlov V, Ricci D, Chaturvedi S, Zhu E, van de Velde H, Enny C, Rizo A, Ferhanoglu B. Frontline rituximab, cyclophosphamide, doxorubicin, and prednisone with bortezomib (VR-CAP) or vincristine (R-CHOP) for non-GCB DLBCL. Blood. 2015 Oct 15;126(16):1893-901. doi: 10.1182/blood-2015-03-632430. Epub 2015 Jul 31.

    PubMed 26232170

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VELCADE, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by Millennium Pharmaceuticals, Inc. at 1 site in Belgium.

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

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. 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 13 Jan 2014. 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 Belgium. 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?

Yes. Results are posted in the registry (first posted 27 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Complete Response (CR) Rate (time frame: 6 cycles). 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 NCT01040871, 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 13 Jan 2014.

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Clinical Trial NCT01040871 | AzTrials