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Motexafin gadolinium

Photosensitizing Agents

motexafin gadolinium

Andrew Evens, DO

Neil E Kay, MD

The primary purpose of this study is to evaluate the safety, toxicities, dosage and response rate for an investigational drug, motexafin gadolinium, administered to patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The secondary purpose of this study is to evaluate the clinical benefit rate, the time it takes for a patient's chronic lymphocytic leukemia or small lymphocytic lymphoma to worsen, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening. Additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium.

Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase I/II Trial of Weekly Motexafin Gadolinium (MGd) for Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Pharmacyclics LLC.

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Diffuse Large B-Cell Lymphoma

Richter Syndrome

Participants with R/R B-cell NHL (including diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], marginal zone lymphoma \[MZL\], transformed B-cell NHL (B-NHL), and Richter's transformation to DLBCL) will receive BGB-21447 once a day.

Participants with relapsed/refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) will receive BGB-21447 once a day.

Participants will receive BGB-21447 with up to two dose levels from Cohort A1 for further evaluation of safety and efficacy.

BGB-21447

BeiGene

This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum adminstered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Expansion."

A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies

A Phase 1/1b Open-Label Dose-Escalation Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies

Number of participants with dose limiting toxicities, defined as \[see text in SAP or protocol for specific definition\]

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed and graded based upon the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).

TLS will be determined via laboratory values and assessed by the investigator.

In laboratory tumor lysis syndrome, 2 or more metabolic abnormalities must be present during the 24-hour period within 3 days before the start of study drug treatment or up to 7 days afterward. Clinical tumor lysis syndrome requires the presence of laboratory tumor lysis syndrome plus an increased creatinine level, seizures, cardiac dysrhythmia, or death.

defined as the percentage of patients who achieve partial response or better for diffuse large B-cell lymphoma, marginal zone lymphoma, follicular lymphoma, transformed B-NHL, and Richter's transformation to DLBCL as per the Lugano Classification for non-Hodgkin lymphoma

defined as the time from the first response documentation to the date that progression is documented after treatment initiation or death due to any cause, whichever occurs first.

defined as the time from treatment initiation to the first documentation of response.

defined as the time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma	NCT00290004	Chronic Lymphoc... Small Lymphocyt... Leukemia Lymphoma	motexafin gadol...	18 Years -	Pharmacyclics LLC.
A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies	NCT05828589	Relapsed Non-Ho... Refractory Non-... Relapsed Chroni... Refractory Chro... Relapsed Follic... Relapsed Margin... Relapse Diffuse... Relapsed Small ... Refractory Foll... Refractory Marg... Refractory Smal... Richter Transfo... Refractory Diff... Transformed Non...	BGB-21447	18 Years -	BeiGene
A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies	NCT05828589	Relapsed Non-Ho... Refractory Non-... Relapsed Chroni... Refractory Chro... Relapsed Follic... Relapsed Margin... Relapse Diffuse... Relapsed Small ... Refractory Foll... Refractory Marg... Refractory Smal... Richter Transfo... Refractory Diff... Transformed Non...	BGB-21447	18 Years -	BeiGene
Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma	NCT00290004	Chronic Lymphoc... Small Lymphocyt... Leukemia Lymphoma	motexafin gadol...	18 Years -	Pharmacyclics LLC.

Spots Global Cancer Trial Database for relapsed small lymphocytic lymphoma