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A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma, Relapsed Lymphoma, Refractory Lymphoma, Low-Grade Lymphoma, Intermediate-Grade Lymphoma

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Trial Information

A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma


This study seeks to define the role of gallium nitrate in a specific population of patients
who are expected to have received prior therapy. Preliminary clinical studies have
suggested substantial evidence of antitumor activity in patients with relapsed or refractory
non-Hodgkin's Lymphoma treated with gallium nitrate.

Inclusion Criteria


Low- or intermediate-grade NHL using the International Working Formulation, subtypes IWF
A-G:

Using the Updated REAL/WHO Classification, the following pathologic subtypes are eligible:

- Small lymphocytic lymphoma

- Lymphoplasmacytic lymphoma/immunocytoma

- Follicular lymphoma

- Diffuse large B-cell lymphoma

- Peripheral T-cell lymphoma, not otherwise characterized

Progression of disease following treatment with standard chemotherapy

Bi-dimensionally measurable disease

Performance Status: ECOG < = 2

Patients with mantle cell lymphoma or mycosis fungoides are not eligible

Patients with known history of CNS metastasis are not eligible

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

Genta-GGN202

NCT ID:

NCT00054808

Start Date:

June 2002

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Relapsed Lymphoma
  • Refractory Lymphoma
  • Low-Grade Lymphoma
  • Intermediate-Grade Lymphoma
  • Gallium Nitrate
  • Ganite
  • NHL
  • Relapsed
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

GentaBerkeley Heights, New Jersey  07922