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Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01515176
Recruitment Status : Completed
First Posted : January 23, 2012
Results First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia
Prolymphocytic Leukemia
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Interventions: Drug: Dinaciclib
Other: Laboratory Biomarker Analysis
Biological: Ofatumumab
Other: Pharmacological Study

  Participant Flow

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
Dose Level I: Treatment (Ofatumumab, Dinaciclib) Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.
Dose Level II: Treatment (Ofatumumab, Dinaciclib) Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter

Participant Flow:   Overall Study
    Dose Level I: Treatment (Ofatumumab, Dinaciclib)   Dose Level II: Treatment (Ofatumumab, Dinaciclib)
STARTED   4   32 
COMPLETED   4   32 
NOT COMPLETED   0   0 



  Baseline Characteristics

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
Dose Level I: Treatment (Ofatumumab, Dinaciclib) Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.
Dose Level II: Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
Total Total of all reporting groups

Baseline Measures
   Dose Level I: Treatment (Ofatumumab, Dinaciclib)   Dose Level II:   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   32   36 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      2  50.0%      15  46.9%      17  47.2% 
>=65 years      2  50.0%      17  53.1%      19  52.8% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  50.0%      11  34.4%      13  36.1% 
Male      2  50.0%      21  65.6%      23  63.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      4 100.0%      32 100.0%      36 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      5  15.6%      5  13.9% 
White      4 100.0%      27  84.4%      31  86.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   4   32   36 


  Outcome Measures

1.  Primary:   Maximum-tolerated Dose of Dinaciclib When Given in Combination With Ofatumumab, Defined as a Dose Level Where at Most One of 6 Evaluable Patients Has a Dose Limiting Toxicity (Phase Ia)   [ Time Frame: Day 56 ]

2.  Primary:   Number of Patients With Dose-limiting Toxicity Incidents Graded According to the NCI CTCAE v4.0 (Phase I)   [ Time Frame: Up to day 56 ]

3.  Primary:   Percentage of Patients Who Achieve an Overall Response, Defined as Achieving a Complete Response, an Unconfirmed Complete Response (SLL Only), or a Partial Response (Phase II)   [ Time Frame: Up to 28 weeks ]

4.  Secondary:   Complete Response Rate   [ Time Frame: Up to 28 weeks ]

5.  Secondary:   Overall Survival   [ Time Frame: Time from study entry to death due to any cause, assessed up to 5 years ]

6.  Secondary:   Progression Free Survival   [ Time Frame: Time from study entry to documentation of disease progression and/or death, assessed up to 5 years ]

7.  Secondary:   Time to Treatment Failure   [ Time Frame: Time from study entry to the date patients end treatment, up to 28 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Jeffrey Jones, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-3507
e-mail: Jeffrey.Jones@osumc.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01515176     History of Changes
Other Study ID Numbers: NCI-2012-00101
NCI-2012-00101 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
OSU-11120
OSU11120
CDR0000721353
OSU 11120 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
9031 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
N01CM62207 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
P50CA140158 ( U.S. NIH Grant/Contract )
U01CA076576 ( U.S. NIH Grant/Contract )
UM1CA186712 ( U.S. NIH Grant/Contract )
First Submitted: January 16, 2012
First Posted: January 23, 2012
Results First Submitted: August 11, 2017
Results First Posted: March 15, 2018
Last Update Posted: March 15, 2018