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A Phase 2 Clinical Trial of Rituximab, Cyclophosphamide, Bortezomib (VELCADE®), and Dexamethasone (R-CyBor-D) in Relapsed Low Grade and Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase 2 Clinical Trial of Rituximab, Cyclophosphamide, Bortezomib (VELCADE®), and Dexamethasone (R-CyBor-D) in Relapsed Low Grade and Mantle Cell Lymphoma


OBJECTIVES:

Primary

- To assess tumor response in patients with relapsed or refractory low-grade follicular
lymphoma (grade I or II), mantle cell lymphoma, or lymphoplasmacytic lymphoma
(Waldenstrom macroglobulinemia) treated with rituximab, cyclophosphamide, bortezomib,
and dexamethasone.

Secondary

- To evaluate overall survival, progression-free survival, duration of response, and time
to treatment failure in patients treated with this regimen.

- To describe the adverse event profile (as assessed by NCI CTCAE version 3.0) of this
regimen in these patients.

- To evaluate the quality of life, in terms of patient-reported neurotoxicity, in
patients treated with this regimen.

OUTLINE: Patients receive rituximab IV on day 1, bortezomib IV on days 1, 4, 8, and 11, and
oral cyclophosphamide and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats
every 28 days for up to 12 courses in the absence of disease progression or unacceptable
toxicity.

Patients complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire,
version 4.0) at baseline, on day 1 of courses 3, 6, and 9, and at the completion of study
treatment.

After completion of study treatment, patients are followed every 3-6 months for up to 5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed relapsed or refractory follicular lymphoma (grade I or II),
mantle cell lymphoma (MCL), or lymphoplasmacytic lymphoma (Waldenstrom
macroglobulinemia [WM])

- MCL confirmed by cyclin D1 staining or fluorescent in situ hybridization
[t(11;14)]

- Measurable disease, defined as lymph nodes ≥ 2.0 cm in at least one dimension by CT
scan, PET/CT scan, or MRI

- Patients with WM without lymphadenopathy must have > 10% lymphocytes,
lymphoplasmacytic cells, or plasma cells on a bone marrow aspirate/biopsy AND
quantitative IgM ≥ 400 mg/dL

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy > 3 months

- ANC ≥ 1,200/mm^3

- Platelet count ≥ 75,000/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin ≤ 2.0
mg/dL

- Alkaline phosphatase ≤ 3 times ULN

- AST ≤ 3 times ULN

- Creatinine ≤ 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No comorbid systemic illness or other severe concurrent disease that, in the judgment
of the investigator, would exclude the patient from participating in this study or
would interfere significantly with the proper assessment of safety and adverse events
of the prescribed study regimen

- No known HIV positivity

- No concurrent uncontrolled illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable or uncontrolled angina pectoris

- Cardiac arrhythmias, including severe uncontrolled ventricular arrhythmias

- Psychiatric illness/social situation that would preclude compliance with study
requirements

- No hypersensitivity to bortezomib, boron, or mannitol

- No myocardial infarction within the past 6 months

- No NYHA class III-IV heart failure

- No evidence of acute ischemia by ECG

- No active conduction system abnormalities

- No other malignancy within the past 3 years, except for the following:

- Completely resected basal cell or squamous cell carcinoma of the skin

- In situ malignancy

- Curatively treated prostate cancer deemed to be at low risk

PRIOR CONCURRENT THERAPY:

- More than 14 days since prior investigational drugs

- At least 4 weeks since prior anticancer therapy, including radiotherapy, hormonal
therapy, or surgery

- No other concurrent investigational agents as treatment for the primary malignancy

- No concurrent therapy for other malignancies, except hormonal therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of responses (complete response or partial response)

Safety Issue:

No

Principal Investigator

Craig B. Reeder, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

MC0883

NCT ID:

NCT00711828

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent mantle cell lymphoma
  • Waldenstrom macroglobulinemia
  • Lymphoma
  • Lymphoma, Follicular
  • Waldenstrom Macroglobulinemia
  • Lymphoma, Mantle-Cell

Name

Location

Mayo ClinicRochester, Minnesota  55905
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404