Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

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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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT00054808

Recruitment Status:

Completed

Sponsor:

Genta Incorporated

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There is 1 Location for this study

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Genta
Berkeley Heights New Jersey, 07922, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT00054808

Recruitment Status:

Completed

Sponsor:


Genta Incorporated

How clear is this clinincal trial information?

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