ABT-199 & Ibrutinib in Mantle Cell Lymphoma (AIM) (AIM)
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|ClinicalTrials.gov Identifier: NCT02471391|
Recruitment Status : Unknown
Verified June 2015 by Peter MacCallum Cancer Centre, Australia.
Recruitment status was: Recruiting
First Posted : June 15, 2015
Last Update Posted : August 31, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: ABT-199 Drug: Ibrutinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of ABT-199 in Combination With Ibrutinib in the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma (AIM Study)|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2018|
|Experimental: Ibrutinib + ABT-199||
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471391
|Contact: Constantine Tam, MBBS (Hons), MD, FRACP, FRCPA||+61 3 9656 firstname.lastname@example.org|
|Peter MacCallum Cancer Centre||Recruiting|
|East Melbourne, Victoria, Australia, 3002|
|Contact: Constantine Tam +61 3 9656 1700 email@example.com|
|Royal Melbourne Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3000|
|Contact: Constantine Tam, MBBS (Hons), MD, FRACP, FRCPA +61 3 9656 1700 firstname.lastname@example.org|