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Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00058240
First Posted: April 9, 2003
Last Update Posted: July 2, 2017
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: April 7, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: B-cell Chronic Lymphocytic Leukemia
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Waldenström Macroglobulinemia
Intervention: Drug: alvocidib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with relapsed, symptomatic Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) were enrolled and received treatment between May 2003 and February 2006

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dose Level 1 Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
Dose Level 2 Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
Dose Level 3 Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
Dose Level 4 Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles

Participant Flow for 2 periods

Period 1:   First Dose Level
    Dose Level 1   Dose Level 2   Dose Level 3   Dose Level 4
STARTED   20   3   17   12 
Treated   20   3   17   12 
COMPLETED   20   3   17   12 
NOT COMPLETED   0   0   0   0 

Period 2:   Second Dose Level
    Dose Level 1   Dose Level 2   Dose Level 3   Dose Level 4
STARTED   0   0   2 [1]   4 [2] 
COMPLETED   0   0   2   4 
NOT COMPLETED   0   0   0   0 
[1] 2 patients were previously treated at Dose level 1, relapsed, and retreated at Dose level 3.
[2] 4 patients previously relapsed on a different Dose level and were retreated at Dose level 4.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
52 unique patients due to 6 patients being

Reporting Groups
  Description
Dose Level 1 Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
Dose Level 2 Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles.
Dose Level 3 Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
Dose Level 4 Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
Total Total of all reporting groups

Baseline Measures
   Dose Level 1   Dose Level 2   Dose Level 3   Dose Level 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   3   17   12   52 
Age 
[Units: Years]
Median (Full Range)
 61.5 
 (44 to 84) 
 52 
 (44 to 62) 
 55 
 (39 to 69) 
 60 
 (38 to 75) 
 60 
 (38 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      6  30.0%      2  66.7%      3  17.6%      3  25.0%      14  26.9% 
Male      14  70.0%      1  33.3%      14  82.4%      9  75.0%      38  73.1% 
Region of Enrollment 
[Units: Patients]
         
United States   20   3   17   12   52 


  Outcome Measures
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1.  Primary:   Number of Patients With Dose Limiting Toxicities (DLTs)   [ Time Frame: up to 7 weeks ]

2.  Primary:   Recommended Dose Level of Flavopiridol   [ Time Frame: Up to 6 weeks ]

3.  Secondary:   Overall Response Rate (CR + PR) of Flavopiridol in Patients Evaluated Utilizing the Revised National Cancer Institute-sponsored Working Group Guidelines   [ Time Frame: Up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Byrd, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-3196
e-mail: John.Byrd@osumc.edu


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00058240     History of Changes
Other Study ID Numbers: NCI-2012-01435
NCI-2012-01435 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000287197
NCI-5746
OSU-0055
OSU 0055 ( Other Identifier: Ohio State University Medical Center )
5746 ( Other Identifier: CTEP )
R21CA112947 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
U01CA076576 ( U.S. NIH Grant/Contract )
First Submitted: April 7, 2003
First Posted: April 9, 2003
Results First Submitted: April 7, 2015
Results First Posted: June 2, 2017
Last Update Posted: July 2, 2017