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Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01292135
First received: February 2, 2011
Last updated: July 17, 2014
Last verified: July 2014
Results First Received: February 28, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: B-cell Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Intervention: Drug: PCI-32765

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)

PCI-32765: 420 mg daily

FCR:

  • Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1(Cycle 2 to Cycle 6).
  • Fludarabine: 25 mg/m2/day for 3 days (Days 1 to 3) of each cycle
  • Cyclophosphamide: 250 mg/m2/day for 3 days (Days 1 to 3) of each cycle (Up to 6 Cycle)
PCI-32765 Plus Bendamustine/Rituximab (BR)

PCI-32765: 420 mg daily

BR:

  • Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1 (Cycle 2 to Cycle 6).
  • Bendamustine; 70 mg/m² on Day 1 and 2 of each cycle (Up to 6 Cycles)

Participant Flow:   Overall Study
    PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)     PCI-32765 Plus Bendamustine/Rituximab (BR)  
STARTED     3     30  
COMPLETED     3     21  
NOT COMPLETED     0     9  



  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.
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Reporting Groups
  Description
PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR) PCI-32765: 420 mg daily
PCI-32765 Plus Bendamustine/Rituximab (BR) PCI-32765: 420 mg daily
Total Total of all reporting groups

Baseline Measures
    PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)     PCI-32765 Plus Bendamustine/Rituximab (BR)     Total  
Number of Participants  
[units: participants]
  3     30     33  
Age  
[units: Years]
Mean ± Standard Deviation
  56.3  ± 1.53     61.3  ± 9.58     60.8  ± 9.24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     19     22  
>=65 years     0     11     11  
Gender  
[units: participants]
     
Female     0     5     5  
Male     3     25     28  
Region of Enrollment  
[units: participants]
     
United States     3     30     33  



  Outcome Measures
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1.  Primary:   Incidence of Prolonged Hematologic Toxicity Started in Cycle 1   [ Time Frame: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months. ]

2.  Secondary:   Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib   [ Time Frame: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months. ]

3.  Secondary:   Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0   [ Time Frame: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months. ]

4.  Secondary:   Overall Incidence of Serious Adverse Events (SAEs)   [ Time Frame: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months. ]

5.  Secondary:   Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR])   [ Time Frame: From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months. ]

6.  Secondary:   Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline   [ Time Frame: From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months. ]

7.  Secondary:   Progression Free Survival Rate at 12 Months   [ Time Frame: From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest. ]


  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: Thorsten Graef, MD
Organization: Pharmacyclics
phone: 855.427.8846
e-mail: medinfo@pcyc.com


No publications provided


Responsible Party: Pharmacyclics
ClinicalTrials.gov Identifier: NCT01292135     History of Changes
Other Study ID Numbers: PCYC-1108-CA, PCI-32765
Study First Received: February 2, 2011
Results First Received: February 28, 2014
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration