NCT00030381|TerminatedPhase 1
Study Stopped
Administratively complete.
Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis
Phase I Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)
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Sponsor study identifier
Secondary identifiers
interventional
22
1 country
1
Study Start
December 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2003
Actual (reported)Study Completion
Not reported
Date not reportedIododoxorubicin may dissolve protein deposits and be an effective treatment for primary systemic amyloidosis. Phase I trial to determine the effectiveness of iododoxorubicin in treating patients who have primary systemic amyloidosis
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2001
Date type not reportedThis date has not been verified as actual or estimated.
February 14, 2002
Actual (reported)January 2003
Actual (reported)September 17, 2003
Actual (reported)MTD of IDOX defined as the highest safely-tolerated dose where =< 1 patient experiences DLT with the next higher dose having at least 2 patients who experience DLT
The number and severity of toxicity incidents will indicate the level of tolerance of IDOX in the treatment of primary amyloidosis. Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via CTC standard toxicity grading.
12 weeks
Laboratory correlates
Up to 3 months post treatment
Patients receive iododoxorubicin IV over 15 minutes on days 1, 8, 15, and 22. Treatment repeats every 12 weeks for a total of 4 courses or a cumulative dose of 400 mg/m\^2 in the absence of disease progression or unacceptable toxicity.
Given IV
Correlative studies
Mayo Clinic
Rochester, Minnesota, 55905, United States
Angela Dispenzieri
Mayo Clinic
22 participants (actual enrollment reported by the registry).
First Submitted
February 14, 2002
First Posted
September 17, 2003
Study Start
December 2001
Date type not reportedThis date has not been verified as actual or estimated.
Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 2003
Actual (reported)Last Updated
January 16, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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