Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2022-02-15

Brief Summary

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This research study will evaluate the safety and efficacy of a study drug called Umbralisib (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia that has come back or that has not responded to standard treatment.

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Detailed Description

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Conditions

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Marginal Zone Lymphoma Waldenstrom Macroglobulinemia Non Follicular Indolent Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Marginal Zone Lymphoma (MZL): Umbralisib

Participants with non-follicular indolent non-Hodgkin's lymphoma (iNHL) with MZL as the histology type received umbralisib, 800 milligrams (mg), orally, once daily (QD), until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.

Group Type EXPERIMENTAL

Umbralisib

Intervention Type DRUG

Oral Daily Dose

Waldenstrom's Macroglobulinemia (WM): Umbralisib

Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.

Group Type EXPERIMENTAL

Umbralisib

Intervention Type DRUG

Oral Daily Dose

Interventions

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Umbralisib

Oral Daily Dose

Intervention Type DRUG

Other Intervention Names

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TGR-1202

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of Waldenstroms Macroglobulinemia
* Relapsed or refractory after at least one prior treatment regimen
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria

* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
* Prior autologous stem cell transplant within 6 months of study entry

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No