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First-line Treatment of Mantle Cell Lymphoma of Patients Aged 65 to 80 Years. Evaluate the Efficacy, Toxicity, and Molecular Prognostic Factors of a Proteosome Inhibitor (PS341-VelcadeĀ®) in Association With Chemotherapy and Immunotherapy With Rituximab (Schema RiPAD + C)


Phase 2
65 Years
80 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

First-line Treatment of Mantle Cell Lymphoma of Patients Aged 65 to 80 Years. Evaluate the Efficacy, Toxicity, and Molecular Prognostic Factors of a Proteosome Inhibitor (PS341-VelcadeĀ®) in Association With Chemotherapy and Immunotherapy With Rituximab (Schema RiPAD + C)


OBJECTIVES:

Primary

- Evaluate the efficacy of rituximab, bortezomib, doxorubicin hydrochloride,
dexamethasone, and chlorambucil as first-line therapy in patients with stage II-IV
mantle cell lymphoma.

Secondary

- Determine the complete response rate in these patients.

- Determine the efficacy, in terms of complete and overall response, by F18
fludeoxyglucose scan.

- Determine overall, disease-free, and event-free survival of these patients.

- Assess tolerability of this regimen in these patients.

- Evaluate the impact of factors, described in previous protocols, on response to therapy
and survival.

- Assess the impact of residual disease in cerebrospinal fluid on survival.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on day 1 (days 1 and 8 of the first course only); bortezomib
IV on days 1, 4, 8, and 11; doxorubicin hydrochloride IV continuously over 24 hours on days
1-4; dexamethasone IV on days 1-4; and oral chlorambucil on days 20-29. Treatment repeats
every 5 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve at least 50% response receive 2 additional courses of therapy.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of mantle cell lymphoma

- Stage II-IV disease

- No neuromeningeal disease

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- No prior cancer except for carcinoma in situ of the cervix or basal cell skin cancer

- LVEF > 50%

- HIV-negative

- Hepatitis B- and C-negative

- No hepatocellular, renal, or bone marrow insufficiency unrelated to lymphoma

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate after 4 courses of therapy

Safety Issue:

No

Principal Investigator

Remy Gressin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

CHU de Grenoble - Hopital de la Tronche

Authority:

United States: Federal Government

Study ID:

CDR0000589544

NCT ID:

NCT00740415

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

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