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

This study is currently recruiting participants.
Verified by Millennium Pharmaceuticals, September 2008

Sponsored by: Millennium Pharmaceuticals
Information provided by: Millennium Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00715208
  Purpose

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.


Condition Intervention Phase
Relapsed Follicular Lymphoma
Drug: VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
Drug: VELCADE, rituximab, cyclophosphamide, and prednisone
Phase II

MedlinePlus related topics:   Lymphoma   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Prednisone    Rituximab    Bortezomib   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Parallel Assignment
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.

Further study details as provided by Millennium Pharmaceuticals:

Primary Outcome Measures:
  • Complete response rate [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety of the drug combinations [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   88
Study Start Date:   September 2008
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
Drug: VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
VELCADE 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 PO on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.
2: Experimental
VELCADE, rituximab, cyclophosphamide, and prednisone
Drug: VELCADE, rituximab, cyclophosphamide, and prednisone
VELCADE 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 by mouth on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Male or female patient 18 years of age or older
  • Pathological diagnosis of follicular lymphoma (any grade)
  • Documented relapse or progression following prior antineoplastic therapy
  • At least 1 measurable tumor mass
  • No clinically significant evidence of active central nervous system lymphoma
  • Karnofsky performance status - greater than or equal to 50.
  • Clinical laboratory values within 21 days prior to enrollment:

    • Absolute neutrophil count - greater than or equal to 1.00 x 10 to the ninth power
    • Platelets - greater than or equal to 100 x 10 to the ninth power for Arm 1 or greater than or equal to 75 x 10 to the ninth power cells for Arm 2.
    • Alanine transaminase less than or equal to 4x upper limit of normal
    • Aspartate transaminase less than or equal to 4x the upper limit of normal
    • Total bilirubin less than 2 x upper limit of normal with a normal direct bilirubin
    • Calculated creatinine clearance greater than or equal to 20 mL/min
  • Female patients must be postmenopausal for at least 1 year, surgically sterile, practicing abstinence, or practicing an effective method of birth control.
  • Male patients must agree to use an acceptable method of contraception (i.e. a condom) for the duration of the study.
  • Patients or the patient's legal representative must have a signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

  • Diagnosed or treated for a malignancy other than 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
  • 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
  • Residual toxic effects of Grade 2 or worse from previous therapy or surgery
  • Peripheral neuropathy of Grade 2 or worse due to any cause
  • Known history of HIV infection
  • Active systemic infection requiring therapy
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • Myocardial infarction within 6 months prior to enrollment or New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities in the opinion of the investigator
  • Residual toxic effects of Grade 2 or worse from previous therapy or surgery
  • Peripheral neuropathy of Grade 2 or worse due to any cause
  • Known history of HIV infection
  • Active systemic infection requiring therapy
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • Myocardial infarction within 6 months prior to enrollment or New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities in the opinion of the investigator
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715208

Contacts
Contact: Christine Colby, PharmD     1-866-835-2233     medical@mlnm.com    

Locations
United States, New York
Columbia University - Herbert Irving Comprehensive Cancer Center     Recruiting
      New York, New York, United States, 10032
      Contact: Rachel Hamelers     212-342-3590     rh2340@columbia.edu    

Sponsors and Collaborators
Millennium Pharmaceuticals
  More Information


Responsible Party:   Millennium Pharmaceuticals, Inc. ( Clinical Research Monitor )
Study ID Numbers:   C05012
First Received:   July 11, 2008
Last Updated:   September 8, 2008
ClinicalTrials.gov Identifier:   NCT00715208
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Prednisone
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Bortezomib
Lymphoma, Follicular
Cyclophosphamide
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Doxorubicin
Follicular lymphoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Antibiotics, Antineoplastic
Hormones
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on September 19, 2008




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