A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
MEI Pharma, Inc.
Study ID
NCT02914938
Phase
PHASE1
Status
Terminated

Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Follicular Lymphoma (FL)
  • High Grade Non-Hodgkin's Lymphoma
  • Mantle Cell Lymphoma (MCL)
  • Marginal Zone B Cell Lymphoma
  • Small Lymphocytic Lymphoma (SLL)

Eligibility Criteria

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

Interventions

  • ME-401 — DRUG
    60 mg
  • Rituximab — DRUG
    IV infusion 375 mg/m2
  • Zanubrutinib — DRUG
    80 and 160 mg bid

Study Details

A Three-Arm Study of ME-401 in Subjects with Relapsed/Refractory CLL/SLL or FL, of ME-401 in Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination with Zanubrutinib in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL

Key Dates

Start date
Oct 31, 2016
Status verified
Dec 2022
Primary completion
Mar 29, 2023
Completion
Mar 29, 2023

Study Design

Enrollment
97 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ME-401 Alone
    This arm is an open-label, dose escalation study to determine the safety, efficacy and pharmacokinetics of ME-401 along with the mBED, MTD, and DLTs. There are 4 planned cohorts which may enroll up to 61 subjects.
  • Experimental: ME-401 in Combination with Rituximab
    The second arm is an open label study to evaluate the safety, efficacy, and pharmacokinetics of ME-401 in combination with rituximab in subjects with various B-cell malignancies. There are two planned cohorts which may enroll up to 30 subjects.
  • Experimental: ME-401 in Combination with Zanubrutinib
    The third arm is an open label study evaluating the safety, efficacy, MTD, DLT and pharmacokinetics of ME-401 in combination with zanubrutinib in subjects with various B-cell malignancies. This arm will include 2 stages: a safety evaluation stage (cohort of 6-12 subjects) and a disease-specific expansion cohort stage (up to 74 subjects).

Primary Outcome Measure

Minimum Biologically Effective Dose (mBED) of ME-401 alone [ Time Frame: 1 year ]

Locations (23)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724-
Compassionate CareCoronaCalifornia92708-
Sylvester Comprehensive Cancer Center (Univ of Miami School of Med)MiamiFlorida33136-
Dana FarberBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Memorial Sloan KetteringBasking RidgeNew Jersey07920-
Memorial Sloan KetteringMiddletownNew Jersey07748-
Memorial Sloan KetteringMontvaleNew Jersey07645-
Memorial Sloan KetteringCommackNew York11725-
Memorial Sloan KetteringHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYU Langone Laura & Isaac - Perlmutter Cancer CenterNew YorkNew York10016-
Stony BrookStony BrookNew York11794-
Memorial Sloan KetteringUniondaleNew York11553-
Cleveland ClinicClevelandOhio44195-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
VanderbiltNashvilleTennessee37240-
University of Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-
Swedish Cancer InstituteEdmondsWashington98026-
Swedish Cancer InstituteIssaquahWashington98029-
Swedish Cancer CenterSeattleWashington98104-
Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZCompassionate Care· Corona, CASylvester Comprehensive Cancer Center (Univ of Miami School of Med)· Miami, FLDana Farber· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MAMemorial Sloan Kettering· Basking Ridge, NJ

Related Studies