This research will test the combination of two new drugs, called ibrutinib and ABT199, taken together in the treatment of Mantle Cell Lymphoma. Other studies have indicated the potential for these drugs to be used in the treatment of participants with Mantle Cell Lymphoma. In this study, the investigators will test the combination of the two drugs together, in order to determine what effects (good and bad) it has on mantle cell lymphoma. This study has two phases. The first phase is the Primary Evaluation Phase and will closely monitor the effects of ibrutinib and ABT199 for a period of 13 months. Participants who complete 13 months of treatment and continue benefiting from the study treatments will be allowed to continue both drugs until progression or intolerance in the Continuation Phase. The purpose of this phase is to provide patients with continuing access to both ibrutinib and ABT199. Patients will receive routine care from clinician, who will record any sideeffects that may be experienced. This is one of the first trials in the world to study the combination of ibrutinib and ABT199 together. Therefore the effectiveness of the combination of the study drugs will be assessed, as will how they affect mantle cell lymphoma and how it develops resistance to the treatments. The investigators also do not know whether combining the two drugs together will cause unexpected side effects. Therefore, the study will monitor patients closely and perform scans, blood tests, bone marrow biopsies and other tests at regular intervals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Complete response measured using IWG at 16 weeks
Time frame: Measured at 16 weeks after commencement of treatment.
Completing 4, 16, 28, 40 and 56 weeks of treatment
Time frame: Assessed at 4, 16, 28, 40 and 56 weeks
Toxicities measured using CTCAE version 4
Time frame: Continuously measured while on treatment up to a maximum of 56 weeks
Overall response (CR + PR) using IWG criteria at 4, 16, 28, 40 and 56 weeks
Time frame: Assessed at 4, 16, 28, 40 and 56 weeks
Complete response using IWG criteria at 4, 16, 28, 40 and 56 weeks
Time frame: Assessed at 4, 16, 28, 40 and 56 weeks
Minimal residual disease (MRD) at 4, 16, 28, 40 and 56 weeks
Time frame: Assessed at 4, 16, 28, 40 and 56 weeks
Progression free survival
Time frame: From start of treatment until the date of first documented progression or date of death from any cause, whichever occures first, assessed up to the date when the last patient has their 13 months assessment.
Overall survival
Time frame: From start of treatment until the date of death from any cause assessed up to the date when the last patient has their 13 months assessment.
Duration of response
Time frame: From first disease response date to the date of earliest recurrance or PD, assessed up to the date when the last patient has their 13 months assessment.
Time to progression
Time frame: From start of treatment until the date of first documented progression assessed up to the date when the last patient has their 13 months assessment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.