Skip to content
Triangle logo TriangleGet started
← Study library

NCT02363439 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2018-01-09

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Participants With Adverse Events

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility 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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
    intervention Names
    1. Drug: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
    label
    IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
    description
    IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401
    name
    IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
5
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia
    measure
    Number of Participants With Adverse Events
    time Frame
    During receipt of study treatment on the trial.
Full study description
brief Summary
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-44c7db4cbb1122b5dd66
      requested nct id
      NCT02363439
      primary nct id
      NCT02363439
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      61a5cd2e3248008b13c86cf54a5ae6726d241ed9b44a0c20decf28b16f846c01
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-44c7db4cbb1122b5dd66
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02363439
      occurrences
      1. context exact
        NCT02363439
        end
        11
        exact text
        NCT02363439
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/46/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      cac7cb5ceeb0a707a991f62add45b92a86096fb1574ec5e0ef8fc4d8a888a09d

    Preserved source evidence · Not medical advice