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Phase I/II Trial of VELCADE+ CHOP-Rituximab in Patients With Previously Untreated Diffuse Large B Cell or Mantle Cell Non-Hodgkin's Lymphoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

Phase I/II Trial of VELCADE+ CHOP-Rituximab in Patients With Previously Untreated Diffuse Large B Cell or Mantle Cell Non-Hodgkin's Lymphoma


Inclusion Criteria:



- Histologically confirmed diagnosis of diffuse large B cell or mantle cell
Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles. For mantle
cell: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-).

- Patient has not received any prior anti-cancer therapy for lymphoma

- Tumor tissue confirmed to express the CD20 antigen

- Available frozen tumor tissue(rebiopsy if needed)

- Patient has measurable disease as defined by a tumor mass > 1.5 cm

- Patient has Stage II, III, or IV disease

- Age > 18 years

- Absolute granulocyte count > 1000 cells/mm3

- Platelet count > 50,000 cells/mm3

- Creatinine < 2.0 x ULN

- Total bilirubin < 2.0 x ULN

Exclusion Criteria:

- Known central nervous system (CNS) involvement by lymphoma

- Known HIV disease

- Patient is pregnant or nursing

- Patient has had major surgery within the last 3 weeks

- Patient is receiving other investigational drugs

- Known peripheral neuropathy > Grade 2

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determine maximum tolerated dose

Outcome Time Frame:

phase I

Safety Issue:

Yes

Principal Investigator

John P Leonard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Institutional Review Board

Study ID:

0309006313

NCT ID:

NCT00151320

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • diffuse large B cell
  • mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Nebraska Medical CenterOmaha, Nebraska  68198
Columbia University College of Physicians and SurgeonsNew York, New York  10032