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Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)

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ClinicalTrials.gov Identifier: NCT01888952
Recruitment Status : Completed
First Posted : June 28, 2013
Results First Posted : February 27, 2017
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Anand B. Karnad, The University of Texas Health Science Center at San Antonio

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced B-cell Lymphoid Malignancies
Interventions Drug: Prednisone
Drug: Roflumilast
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Roflumilast and Prednisone
Hide Arm/Group Description

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.

Prednisone: 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.

Roflumilast: 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.

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Roflumilast and Prednisone
Hide Arm/Group Description

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.

Prednisone: 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.

Roflumilast: 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.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  50.0%
>=65 years
5
  50.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
6
  60.0%
Male
4
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Total Number of Adverse Events.
Hide Description Adverse events were listed using CTCAE Version 4.03 (Common Terminology Criteria for Adverse Events) toxicity grade.
Time Frame Average of 21 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Roflumilast and Prednisone
Hide Arm/Group Description:

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.

Prednisone: 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.

Roflumilast: 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.

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Adverse events
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Roflumilast and Prednisone
Hide Arm/Group Description

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.

Prednisone: 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.

Roflumilast: 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.

All-Cause Mortality
Roflumilast and Prednisone
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Roflumilast and Prednisone
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Roflumilast and Prednisone
Affected / at Risk (%) # Events
Total   2/10 (20.00%)    
General disorders   
Fatigue  2/10 (20.00%)  2
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anand Karnad, MD
Organization: CTRC@UTHSCSA
Phone: 210-450-1000
EMail: karnad@uthscsa.edu
Layout table for additonal information
Responsible Party: Anand B. Karnad, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01888952    
Other Study ID Numbers: CTRC 13-0013
HSC20130307H ( Other Identifier: University of Texas Health Science Center San Antonio IRB (UTHSCSA) )
First Submitted: May 8, 2013
First Posted: June 28, 2013
Results First Submitted: December 23, 2015
Results First Posted: February 27, 2017
Last Update Posted: February 27, 2017