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Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL)


N/A
17 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL)


OBJECTIVES:

Primary

- To determine the overall response rate, in terms of complete response (CR), unconfirmed
CR, and partial response, in patients with follicular lymphoma or marginal zone
lymphoma treated with rituximab, cyclophosphamide, bortezomib, and prednisone (R-CVelP)
as first line of treatment.

Secondary

- To determine progression-free survival of patients treated with this regimen.

- To determine overall survival of patients treated with this regimen.

- To determine the safety and tolerance to R-CVelP in these patients.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed grade 1 or 2 follicular lymphoma (FL) or marginal zone
lymphoma (MZL)

- Stage III or IV disease

- Measurable or evaluable disease

- Previously untreated disease

PATIENT CHARACTERISTICS:

- ECOG performance status 1-3

- ANC > 1,000/mm³

- Platelet count > 100,000/mm³ (unless due to lymphoma)

- Bilirubin < 2.0 mg/dL

- Creatinine < 2 mg/dL (unless due to lymphoma)

- AST, ALT, and alkaline phosphatase < 3 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No myocardial infarction within the past 6 months

- No NYHA class III-IV heart failure

- No uncontrolled angina

- No severe uncontrolled ventricular arrhythmias

- No ECG evidence of acute ischemia or active conductive system abnormalities

- No hypersensitivity to boron or mannitol

- No serious medical or psychiatric illness likely to interfere with participation in
this clinical study

- No history of HIV infection

- No concurrent or previous malignancy with poor prognosis (< 90% probability of
survival at 5 years) or actively treated for a second malignancy

- No peripheral neuropathy ≥ grade 2 within the past 14 days

PRIOR CONCURRENT THERAPY:

- No prior therapy for this disease including chemotherapy, single-agent rituximab, or
radiotherapy

- No other concurrent anticancer therapy including chemotherapy, radiation, hormonal
treatment, or immunotherapy

- At least 14 days since prior and no other concurrent investigational drugs

- No concurrent participation in another clinical study

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate, According to the International Workshop Criteria (IWC)

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Denise Pereira, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20070963

NCT ID:

NCT00772668

Start Date:

September 2008

Completion Date:

February 2011

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, B-Cell, Marginal Zone

Name

Location

University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136