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Relapsed Follicular LymphomaPhase 2NCT00715208

Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma

A Phase 2 study testing rituximab, cyclophosphamide and doxorubicin in people with Relapsed Follicular Lymphoma, run by Millennium Pharmaceuticals, Inc. at 43 sites in 2 countries.

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

This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed Follicular Lymphoma
What is being tested?
rituximab, cyclophosphamide and doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
43 sitesin 2 countries
Study dates
Sep 2008to Mar 2011
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 patient 18 years of age or older
  • Pathological diagnosis of follicular lymphoma (any grade) or marginal zone lymphoma. Patients with transformed follicular lymphoma are eligible, provided there has previously been pathologic documentation of follicular lymphoma.
  • Documented relapse or progression following prior antineoplastic therapy
  • At least 1 measurable tumor mass that is greater than 1.5 cm in the long axis and greater than 1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation
  • No clinically significant evidence of active central nervous system lymphoma
  • Karnofsky performance status (KPS) ≥50 (equivalent to Eastern Cooperative Group Oncology Group [ECOG] status ≤2)

Who cannot join

  • Diagnosed or treated for a malignancy other than Non-Hodgkin's Lymphoma (NHL) within 2 years of first dose, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Patients with prostate cancer who were treated with definitive radiotherapy who have a serum prostate-specific antigen <1 ng/mL are not excluded. Patients are not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in situ malignancy that was adequately treated.
  • Received any of the following treatments or procedures outside of the specified timeframes:
  • Prior treatment with VELCADE
  • Prior treatment with a cumulative dose of doxorubicin of more than 100 mg/m2, if assigned to Arm A (VELCADE-R-CAP)
  • Antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before Day 1 of Cycle 1
  • Nitrosoureas within 6 weeks before Day 1 of Cycle 1
Show all 9Show fewer
  • Radioimmunoconjugates within 10 weeks before Day 1 of Cycle 1
  • Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time
  • Major surgery within 2 weeks before Day 1 of Cycle 1

Trial locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

United States42 sites

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Medical Oncology, LLC

    Baton Rouge, Louisiana, 70809

  • Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Southern Illinois Hematology Oncology

    Centralia, Illinois, 62801

  • St. Louis Cancer Care, LLP

    Chesterfield, Missouri, 63017

  • Alexian Brothers Hospital Network

    Elk Grove Village, Illinois, 60007

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Pacific Coast Hematology Oncology Medical Group

    Fountain Valley, California, 92708

  • Marshall University

    Huntington, West Virginia, 25701

  • Hutchinson Clinic

    Hutchinson, Kansas, 67502

  • Jackson Oncology Associates, PLLC

    Jackson, Mississippi, 39202

  • Kalamazoo Hematology and Oncology

    Kalamazoo, Michigan, 49048

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Nebraska Hematology-Oncology, PC

    Lincoln, Nebraska, 68506

  • Loma Linda U Cancer Center

    Loma Linda, California, 92354

  • Northwest Georgia Oncology Centers, PC

    Marietta, Georgia, 30060

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • West Virginia University Health Science Center

    Morgantown, West Virginia, 26505

  • Northwest Alabama Center, PC

    Muscle Shoals, Alabama, 35661

  • Cancer Care Center, Inc.

    New Albany, Indiana, 47150

  • NYU Clinical Cancer Center

    New York, New York, 10016

  • Great Plains Regional Medical Center

    North Platte, Nebraska, 69101

  • Ocala Cancer Institute

    Ocala, Florida, 34471

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Oklahoma Oncology and Hematology, PC

    Oklahoma City, Oklahoma, 73112

  • Purchase Cancer Group

    Paducah, Kentucky, 42001

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • Western Pennsylvania Cancer Institute

    Pittsburgh, Pennsylvania, 15224

  • Desert Hematology Medical Group, Inc.

    Rancho Mirage, California, 92270

  • HOPE Oncology

    Richardson, Texas, 75080

  • Interlakes Foundation

    Rochester, New York, 14623

  • Siouxland Hematology Oncology Associates

    Sioux City, Iowa, 51101

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Clintell, Inc.

    Skokie, Illinois, 60077

  • Cancer Center of Central Connecticut

    Southington, Connecticut, 06498

  • Oklahoma Oncology and Hematology, PC

    Tulsa, Oklahoma, 74136

  • New York Medical College

    Valhalla, New York, 10595

  • Landmark Medical Center

    Woonsocket, Rhode Island, 02895

Other trials in United States

Puerto Rico1 site

  • Auxilio Cancer Center

    Hato Rey, 00919

Other trials in Puerto Rico

About this study

Official title: A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma.

This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone (VELCADE-R-CP) based on investigator preference. Following completion of the treatment period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.

Medical subject headings
Lymphoma, Follicular

What participants receive

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

Study groups in NCT00715208
Study groupRoleWhat they receive
VELCADE R-CAPExperimentalVELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 750 mg/m2 intravenous on Day 1, doxorubicin 50 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.
Receives: Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: VELCADE; Drug: prednisone
VELCADE R-CPExperimentalVELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 intravenous on Day 1, cyclophosphamide 1000 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.
Receives: Drug: rituximab; Drug: cyclophosphamide; Drug: VELCADE; Drug: prednisone

What is being measured

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

  1. Number of Patients With Complete Response (CR)

    Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.

    Measured: 30 weeks

Secondary outcomes (4)

  1. Number of Participants With Overall Response (OR)

    OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria.

    CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET.

    Measured: 30 weeks

  2. Percentage of Participants With Progression-free Survival (PFS) at 1 Year

    PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better).

    Measured: Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD

  3. Duration of Response

    Time (in months) from the first documentation of a response (CR or partial response [PR]) to the date of first documentation of progressive disease or relapse from complete response.

    CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria.

    Measured: 2 years

  4. Number of Patients Who Experienced at Least One Serious Adverse Event

    Measured: From completion of informed consent through 30 days after the last dose of study drug

Timeline

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

  1. First posted15 Jul 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionFeb 2011
  4. Study completionMar 2011

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00715208
Sponsor's protocol ID
C05012
Status last verified
Apr 2013
First submitted
11 Jul 2008
Last updated
29 Apr 2013

Publications

  • Craig M, Hanna WT, Cabanillas F, Chen CS, Esseltine DL, Neuwirth R, O'Connor OA. Phase II study of bortezomib in combination with rituximab, cyclophosphamide and prednisone with or without doxorubicin followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma. Br J Haematol. 2014 Sep;166(6):920-8. doi: 10.1111/bjh.12991. Epub 2014 Jul 9.

    PubMed 25039282

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab, cyclophosphamide and doxorubicin in people with Relapsed Follicular Lymphoma, run by Millennium Pharmaceuticals, Inc. at 43 sites in 2 countries.

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 9 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 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Puerto Rico. 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 29 Apr 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?

Number of Patients With Complete Response (CR) (time frame: 30 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 NCT00715208, 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 29 Apr 2013.

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