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

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ClinicalTrials.gov Identifier: NCT02363439
Recruitment Status : Completed
First Posted : February 16, 2015
Results First Posted : November 13, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.

Study Description
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Brief Summary:
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.

Condition or disease Intervention/treatment Phase
Waldenstrom's Macroglobulinemia Drug: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly Phase 1 Phase 2

Detailed Description:
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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study to Evaluate the Long-Term Safety, Tolerability, and Clinical Activity of IMO-8400 in Patients With Relapsed or Refractory Waldenström's Macroglobulinemia Who Completed Study 8400-401
Study Start Date : November 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
 Drug: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: During receipt of study treatment on the trial. ]
    Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363439


Sponsors and Collaborators
Idera Pharmaceuticals, Inc.
Investigators
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Study Director: Mark Cornfeld, MD, MPH Idera Pharmaceuticals, Inc.
More Information
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Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02363439     History of Changes
Other Study ID Numbers: 8400-404
First Posted: February 16, 2015    Key Record Dates
Results First Posted: November 13, 2017
Last Update Posted: January 9, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
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Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases