Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Motexafin gadolinium

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Lymphoma, Non-Hodgkin's Lymphoma, Indolent lymphoma, Relapsed lymphoma, Refractory lymphoma, Motexafin gadolinium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥ 18 years old Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy ECOG performance status score either 0 or 1 Willing and able to provide written informed consent Exclusion Criteria: Laboratory values of: Platelet count < 50,000/µL AST or ALT > 2 x the upper limit of normal (ULN) Total bilirubin > 2 x ULN Creatinine > 2.0 mg/dL and Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression) Uncontrolled hypertension Known history of porphyria, G6PD deficiency, HIV

Sites / Locations

Outcomes

Primary Outcome Measures

Clinical response rate

Secondary Outcome Measures

Progression-free survival

Duration of clinical response

Safety and tolerability

Full Information

NCT ID

NCT00086034

First Posted

June 21, 2004

Last Updated

May 11, 2007

Sponsor

Pharmacyclics LLC.

1. Study Identification

Unique Protocol Identification Number

NCT00086034

Brief Title

Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma

Official Title

Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Pharmacyclics LLC.

4. Oversight

5. Study Description

Brief Summary

The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Non-Hodgkin's Lymphoma

Keywords

Lymphoma, Non-Hodgkin's Lymphoma, Indolent lymphoma, Relapsed lymphoma, Refractory lymphoma, Motexafin gadolinium

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Motexafin gadolinium

Primary Outcome Measure Information:

Title

Clinical response rate

Secondary Outcome Measure Information:

Title

Progression-free survival

Title

Duration of clinical response

Title

Safety and tolerability

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: ≥ 18 years old Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy ECOG performance status score either 0 or 1 Willing and able to provide written informed consent Exclusion Criteria: Laboratory values of: Platelet count < 50,000/µL AST or ALT > 2 x the upper limit of normal (ULN) Total bilirubin > 2 x ULN Creatinine > 2.0 mg/dL and Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression) Uncontrolled hypertension Known history of porphyria, G6PD deficiency, HIV

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brad Kahl, MD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Lymphoma, Non-Hodgkin's Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial