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Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL

This study has been terminated.
(Funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772668
First Posted: October 15, 2008
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Denise Pereira, University of Miami
  Purpose

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving rituximab together with cyclophosphamide, bortezomib, and prednisone may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving rituximab together with cyclophosphamide, bortezomib, and prednisone works as first-line therapy in treating patients with stage III or stage IV follicular lymphoma or marginal zone lymphoma.


Condition Intervention
Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Drug: Rituximab Drug: Bortezomib Drug: Cyclophosphamide Drug: Prednisone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL)

Resource links provided by NLM:


Further study details as provided by Denise Pereira, University of Miami:

Primary Outcome Measures:
  • Overall Response Rate, According to the International Workshop Criteria (IWC) for Non-Hodgkin's Lymphoma (NHL) [ Time Frame: Post cycles 2,4,6,8 and then every 3 months, about 2 years ]

    Rate of overall response (CR, CRu, PR) to protocol therapy according to International Workshop Criteria (IWC):

    • Complete Response (CR) includes complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL;
    • Complete Response Unconfirmed (CRu) includes above CR criteria but a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product of the perpendicular diameters (SPD), or indeterminate bone marrow;
    • Partial Response (PR) includes >= 50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen.


Secondary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]
    Progression free-survival will be assessed according to according to the International Workshop Criteria (IWC). Progression-free survival will be measured as the time from date of enrollment to relapse, progression or death due to follicular lymphoma (FL) or marginal zone lymphoma (MZL), whichever occurs first. Participants who do not experience relapse or progression, and those who die from causes other than cancer, will be censored at the date of last contact.

  • Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Overall survival (OS) will be measured as the time from date of enrollment to death from any cause. For patients who remain alive, survival time will be censored at the date of last contact.

  • Rate of Toxicity in Study Participants [ Time Frame: Up to 5 years ]
    Safety and tolerance to protocol therapy as evidenced by the rate of toxicity (serious adverse events and study-related adverse events) in study participants


Enrollment: 3
Actual Study Start Date: September 25, 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RCVELP

Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):

  • Rituximab

    • Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles
    • Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles
  • Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles
  • Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles
  • Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Drug: Rituximab
Administered intravenously during induction and maintenance therapy per protocol.
Other Name: Rituxan
Drug: Bortezomib
Administered intravenously per protocol.
Other Name: Velcade
Drug: Cyclophosphamide
Administered intravenously per protocol.
Other Name: Cytoxan
Drug: Prednisone
Administered orally (PO) per protocol.
Other Name: Deltasone

Detailed Description:

OUTLINE:

  • Induction therapy: Patients receive rituximab IV and cyclophosphamide IV over 30 minutes on day 1, bortezomib IV on days 1 and 8, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance therapy.
  • Maintenance therapy: Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Histologically confirmed, untreated follicular lymphoma (FL) grade I, II or marginal zone lymphoma (MZL) Stage III or IV
  • Presence of measurable or evaluable disease
  • Age >17 years old
  • Patients must have normal organ and marrow function as defined below, within 14 days of enrollment:

    • Serum bilirubin < 2.0 mg/dL
    • serum creatinine < 2 mg/dL unless due to lymphoma
    • Absolute Neutrophil Count (ANC) >1000/mm3
    • Platelets >100,000/mm3 unless due to lymphoma
    • Aspartate Transaminase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphatase < 3x the upper limit of normal
  • Eastern Cooperative Oncology Group (ECOG) performance status of 1, 2, 3
  • No prior therapy for the FL or MZL including chemotherapy, single agent rituximab and radiation therapy
  • Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Male subject agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria

  • Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 5), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Patient has hypersensitivity to boron or mannitol.
  • Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Patient has received other investigational drugs with 14 days before enrollment
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • History of HIV infection (testing not required)
  • Concurrent or previous malignancy whose prognosis is poor (< 90% probability of survival at 5 years) or those who are actively being treated for a second malignancy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772668


Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Denise Pereira, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Responsible Party: Denise Pereira, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00772668     History of Changes
Other Study ID Numbers: 20070963
SCCC-2006120 ( Other Identifier: UM/Sylvester Comprehensive Cancer Center )
First Submitted: October 12, 2008
First Posted: October 15, 2008
Results First Submitted: January 18, 2013
Results First Posted: February 21, 2013
Last Update Posted: December 11, 2017
Last Verified: November 2017

Keywords provided by Denise Pereira, University of Miami:
stage III grade 1 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage III marginal zone lymphoma
stage IV marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Cyclophosphamide
Rituximab
Prednisone
Bortezomib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal