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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02044796
Other study ID # 2734.00
Secondary ID NCI-2013-0246527
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 23, 2014
Est. completion date April 16, 2018

Study information

Verified date December 2019
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I/II trial studies the side effects and best dose of mitoxantrone hydrochloride when given together with filgrastim, cladribine, and cytarabine and to see how well they work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes that is newly diagnosed, has returned, or does not respond to treatment. Drugs used in chemotherapy, such as filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.


Description:

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Study Design


Related Conditions & MeSH terms

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Intervention

Drug:
Cladribine
Given IV
Cytarabine
Given IV
Biological:
Filgrastim
Given SC
Other:
Laboratory Biomarker Analysis
Correlative studies
Drug:
Mitoxantrone Hydrochloride
Given IV

Locations

Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Dose Limiting Toxicities of Mitoxantrone (Phase I, Dose Level 4) Defined as the highest dose studied in which the incidence of dose-limiting toxicity is < 33%, graded according to NCI Common Terminology Criteria for Adverse Events version 4.0 Up to day 45 after start of induction chemotherapy
Primary Minimal Residual Disease Negative Complete Remission Rate in Patients With Newly Diagnosed Disease (Phase II) Remission Rate defined as Recist Category of Complete Resposne (CR) Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size(<10 mm short axis). Up to day 45 after start of second course of induction chemotherapy
Secondary Overall Survival (Phase II) Number of subjects that have survived From date of randomization until the date of death from any cause, assessed up to 12 months
Secondary Remission Rate (Complete Remission and Complete Remission With Incomplete Platelet Count Recovery) of This Regimen in Patients With Relapsed/Refractory Disease (Phase II) Up to 5 years
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