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Clofarabine and Rituximab in Treating Patients With Relapsed Non-Hodgkin Lymphoma

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691652
First Posted: June 5, 2008
Last Update Posted: October 3, 2011
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
Results First Submitted: August 11, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Biological: rituximab
Drug: clofarabine
Genetic: DNA methylation analysis
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: polymerase chain reaction
Other: high performance liquid chromatography
Other: laboratory biomarker analysis

  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
No text entered.

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
Oral Clofarabine + Rituximab in Relapsed B Cell NHL

Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).

Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV

Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg

Phase II:

Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV


Participant Flow:   Overall Study
    Oral Clofarabine + Rituximab in Relapsed B Cell NHL
STARTED   2 
COMPLETED   1 
NOT COMPLETED   1 



  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.
No text entered.

Reporting Groups
  Description
Oral Clofarabine + Rituximab in Relapsed B Cell NHL

Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).

Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV

Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg

Phase II:

Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV


Baseline Measures
   Oral Clofarabine + Rituximab in Relapsed B Cell NHL 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   1 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.5  (4.949) 
Gender 
[Units: Participants]
 
Female   1 
Male   1 
Region of Enrollment 
[Units: Participants]
 
United States   2 


  Outcome Measures

1.  Primary:   The Maximum Tolerated Dose (MTD) of Oral Clofarabine in Adult Patients With Relapsed CD20+ Non-Hodgkin Lymphoma(NHL)   [ Time Frame: 14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days ]

2.  Primary:   Estimate Objective Response Rates of Oral Clofarabine in Combination With Rituximab in Relapsed CD20+NHL   [ Time Frame: Oral Clofarabine x 14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Determine One-year Progression Free Survival Using the MTD of Clofarabine With Rituximab in Relapsed CD20+NHL   [ Time Frame: One year after study drug(s) have been given. Duration of study up to 1 year. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Determine the Safety and Efficacy of Clofarabine in Combination With Rituximab   [ Time Frame: Duration of the study, up to 1 year. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Whether Clofarabine Acts as an Inhibitor of DNA Methylation Similar to Cladribine by Performing Scientific Correlates   [ Time Frame: Duration of the study, up to 1 year. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Whether Response to Clofarabine Alone or in Combination With Rituximab Correlates With Changes in Global Serum DNA Methylation Index   [ Time Frame: Duration of the study, up to 1 year. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Identity of the Gene Activated by Clofarabine Therapy by Using Genomic DNA and RNA Array Technology   [ Time Frame: Twice monthly at standard of care visits for 3 months post last cycle of chemotherapy. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Craig Okada
Organization: OHSU Knight Cancer Institute
phone: 503-494-1080
e-mail: Okadac@ohsu.edu



Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00691652     History of Changes
Other Study ID Numbers: CDR0000597410
P30CA069533 ( U.S. NIH Grant/Contract )
OHSU-HEM-07156-L
IRB#4101
GENZYME-OHSU-HEM-07156-L
First Submitted: June 4, 2008
First Posted: June 5, 2008
Results First Submitted: August 11, 2011
Results First Posted: September 16, 2011
Last Update Posted: October 3, 2011