Phase II Ofatumumab/Methylprednisolone Followed by Ofatumumab/Lenalidomide for Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
The main purpose of this study is to see if ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help people with Chronic Lymphocytic Leukemia (CLL) get rid of their CLL for a long period of time. Researchers also want to find out if the combination of ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide is safe and tolerable.
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Drug: High Dose Methylprednisolone (HDMP)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Untreated CLL/SLL The HiLOG Trial|
- Number of Participants With Complete Response (CR) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]The primary endpoint for this trial is the combined complete and partial response rate to the protocol therapy at 3 months, which is also the end of Cycle 3. The objective response (CR+PR) rate will be summarized using both a point estimate and its exact confidence interval based on the binomial distribution.
- Number of Participants With Partial Response (PR) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]The primary endpoint for this trial is the combined complete and partial response rate to the protocol therapy at 3 months, which is also the end of Cycle 3. The objective response (CR+PR) rate will be summarized using both a point estimate and its exact confidence interval based on the binomial distribution.
- Number of Participants With Progression/Relapse Free Survival (PFS) [ Time Frame: 36 Months ] [ Designated as safety issue: No ]Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Confidence intervals for the median and survival rates at different time points will be constructed if needed.
- Number of Participants With Overall Survival (OS) [ Time Frame: 36 Months ] [ Designated as safety issue: No ]Overall survival will be summarized with the Kaplan-Meier curve.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/Methylprednisolone plus Ofatumumab/Lenalidomide
Drug: High Dose Methylprednisolone (HDMP)
HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Other Name: HDMPDrug: Ofatumumab
Ofatumumab infusion will be administered immediately after HDMP.
Other Name: Arzerra®Drug: Lenalidomide
The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
This is a phase II, single institution, and non-randomized study of patients with untreated CLL/SLL, utilizing a two-stage trial design. The primary endpoint for this trial is the combined complete and partial response rate (at 3 months-the end of cycle 3) to the protocol therapy. We anticipate this trial will have a complete response (CR) and partial response (PR) rate of at least 80%.
A two-stage design is employed for this trial. The null/unacceptable CR+PR response rate is ≤ 60% while the anticipated true response rate to the protocol treatment is at least 80% for each disease cohort. At the first stage, 26 patients will be accrued to the trial. If 15 or fewer of these patients respond, then the trial will be terminated early and the response rate to the protocol treatment will be deemed unacceptable (≤ 60%). Otherwise, if more than 15 patients respond during the first stage, an additional 19 patients will be enrolled to this trial during stage 2 for a total of 45 patients. If 32 or fewer of these 45 patients respond to the protocol treatment at the end of stage 2, no further investigation of the protocol treatment is considered warranted. On the other hand, if more than 32 patients out of the 45 enrolled patients respond, the protocol treatment will be considered promising. If the true response rate is ≤ 60%, the probability of ending the trial at stage 1 is 0.48. If, however, the true response rate is at least 80%, then the probability of ending the trial at stage 1 is only 0.01. This two-stage design has an overall alpha level of 0.045 and a power of 0.90.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496976
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Elyce Turba, RN 813-745-1706 email@example.com|
|Principal Investigator: Celeste Bello, M.D.|
|Sub-Investigator: Jeffrey Lancet, M.D.|
|Sub-Investigator: Lubomir Sokol, M.D., Ph.D.|
|Sub-Investigator: Javier Pinilla-Ibarz, M.D., Ph.D.|
|Sub-Investigator: Rami Komrokji, M.D.|
|Sub-Investigator: Bijal Shah, M.D.|
|Sub-Investigator: Julio Chavez, M.D.|
|Principal Investigator:||Celeste Bello, M.D.||H. Lee Moffitt Cancer Center and Research Institute|