Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01888952|
Recruitment Status : Completed
First Posted : June 28, 2013
Results First Posted : February 27, 2017
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced B-cell Lymphoid Malignancies||Drug: Prednisone Drug: Roflumilast||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Roflumilast and Prednisone
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.
Other Name: Deltasone
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.
Other Name: Daliresp
- Total Number of Adverse Events. [ Time Frame: Average of 21 days. ]Adverse events were listed using CTCAE Version 4.03 (Common Terminology Criteria for Adverse Events) toxicity grade.
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): NCT01888952
|United States, Texas|
|Ctrc @ Uthscsa|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Anand Karnad, MD||CTRC @ UTHSCSA|
|Principal Investigator:||Ricardo Aguiar, MD PhD||CTRC @ UTHSCSA|