A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02756247
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to find out if the combination of buparlisib and ibrutinib will lead to better treatment results in patients with relapsed or refractory Follicular lymphoma, (FL) Mantle cell lymphoma (MCL) or Diffuse Large B-cell lymphoma (DLBCL). The investigators are using buparlisib and ibrutinib because both drugs seem to block different proteins that allow cancer cells to keep growing. Blocking these proteins may help by making the cancer cells undergo cell death, which will stop uncontrolled tumor growth.

Key Dates

Start date
May 9, 2016
Status verified
Oct 2022
Primary completion
Oct 6, 2022
Completion
Oct 6, 2022

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Buparlisib and Ibrutinib
    This is a two stage protocol comprised of a single institution phase Ib dose escalation trial. The first stage is a standard 3+3 phase I dose escalation trial to assess the safety of buparlisib and ibrutinib. The second stage is a single center expansion cohort in MCL, FL and DLBCL respectively evaluating the efficacy of buparlisib and ibrutinib combination. Treatment will be with ibrutinib orally daily and buparlisib orally daily. A cycle is defined as 4 weeks of therapy. Therapy will continue until disease progression, intolerable toxicities or death with a maximum duration for 36 cycles, not exceeding 36 months on therapy.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 1 year ]

Locations (6)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NYMemorial Sloan Kettering Nassau· Uniondale, NY

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