PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab
|First Received Date ICMJE||May 25, 2010|
|Last Updated Date||July 19, 2011|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Overall Response Rate/ Efficacy [ Designated as safety issue: No ]
The primary objective for this trial is to evaluate the overall response rate (CR+PR) of bendamustine and ofatumumab in patients with relapsed/refractory CLL.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01131247 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab|
|Official Title ICMJE||PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB|
Ofatumumab (Azerra) + bendamustine (Trenda)
Route of Administration:
This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given alone. Ofatumumab is FDA approved for the treatment of relapsed/refractory CLL.
Approximately 37 relapsed/refractory CLL subjects will participate in this study over two years.
A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV 300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only.
Patients will be followed monthly for six months, then every three months for five years then annually thereafter.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Chronic Lymphocytic Leukemia (CLL)|
|Intervention ICMJE||Drug: ofatumumab + bendamustine
Loading dose of ofatumumab at 300mg IV with subsequent doses at 100mg IV on D1 of all cycles (maximum of 6 cycles) in combination with bendamustine 90mg/m2 on day 2 of all cycles. Neulasta 6mg SQ will also be given on day 8 of cycle 1 only.
|Study Arm (s)||Experimental: ofatumumab + bendamustine
Intervention: Drug: ofatumumab + bendamustine
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Estimated Enrollment ICMJE||37|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Other protocol specific criteria may apply
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01131247|
|Other Study ID Numbers ICMJE||NVCI 09-15, 18083/6265|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Mark Kirschbaum, MD, Nevada Cancer Institute|
|Study Sponsor ICMJE||Nevada Cancer Institute|
|Information Provided By||Nevada Cancer Institute|
|Verification Date||July 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP