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Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma

G

Genta Incorporated

Status and phase

Completed
Phase 2

Conditions

Refractory Lymphoma
Non-Hodgkin's Lymphoma
Relapsed Lymphoma
Low-Grade Lymphoma
Intermediate-Grade Lymphoma

Treatments

Drug: gallium nitrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00054808
Genta-GGN202

Details and patient eligibility

About

Eligible patients will have low- or intermediate-grade Non-Hodgkin's Lymphoma (NHL) that has progressed after standard chemotherapy. Patients will receive gallium nitrate 300 mg/m2/day by continuous IV infusion for 7 consecutive days using a portable infusion pump. Hospitalization is not required. Stable or responding patients will receive additional gallium nitrate infusions every 3 weeks until the time of disease progression, for a maximum total of 8 infusions, or 2 cycles after complete remission has been documented.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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