Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401

Idera Pharmaceuticals, Inc.5 enrolled

Overview

An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.

Patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (NCT02092909) will continue to receive IMO-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with IMO-8400 have been met.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Waldenstrom's Macroglobulinemia

Interventions

IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weeklyDRUG

IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Completed 24 weeks of treatment in Protocol 8400-401 Exclusion Criteria: * Grade 3 (or higher) adverse event assessed as treatment-related at any time during the course of treatment under Protocol 8400-401. * Has evidence of disease progression under Protocol 8400-401. * Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia

Time frame: During receipt of study treatment on the trial.

Data from ClinicalTrials.gov

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