NCT01888952|CompletedEarly Phase 1ResultsDMC
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Sponsor study identifier
Secondary identifiers
OTHER · University of Texas Health Science Center San Antonio IRB (UTHSCSA)
interventional
10
1 country
1
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)This is a Phase 0/1 open-label, non-randomized, biomarker and pharmacodynamic study in patients with advanced B-cell lymphoid malignancies, including B-cell chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), acute lymphocytic leukemia (ALL), multiple myeloma (MM), Waldenström's macroglobulinemia (WM), mantle cell lymphoma, follicular lymphoma, or diffuse large B-cell lymphoma (DLBCL) who have failed at least one prior therapy and for whom no standard curative therapy exists. Patients with advanced stage disease are those whose disease is resistant or refractory to standard chemotherapy or biological therapies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click 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.
May 8, 2013
Actual (reported)June 28, 2013
Actual (reported)July 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 2015
Actual (reported)January 2015
Actual (reported)February 27, 2017
Actual (reported)Total Number of Adverse Events.
Adverse events were listed using CTCAE Version 4.03 (Common Terminology Criteria for Adverse Events) toxicity grade.
Average of 21 days.
Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle). In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast. In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.
Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.
Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease.
Ctrc @ Uthscsa
San Antonio, Texas, 78229, United States
Anand Karnad, MD
CTRC @ UTHSCSA
Ricardo Aguiar, MD PhD
CTRC @ UTHSCSA
10 participants (actual enrollment reported by the registry).
First Submitted
May 8, 2013
First Posted
June 28, 2013
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
The Effect of Prednisone on Atherogenesis as Studied in the Macrophage Foam Cell Formation Model System.
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 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
February 27, 2017
Results First Posted
February 27, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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