A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML

Part of paid clinical trials in Duarte, California.

Sponsor
MEI Pharma, Inc.
Study ID
NCT03547115
Phase
PHASE1
Status
Terminated

Conditions

  • Acute Myeloid Leukemia (AML)
  • Chronic Lymphocytic Leukemia (CLL)
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Follicular Lymphoma (FL)
  • Mantle Cell Lymphoma (MCL)
  • Marginal Zone Lymphoma (MZL)
  • Small Lymphocytic Lymphoma (SLL)

Eligibility Criteria

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

Interventions

  • voruciclib monotherapy — DRUG
    Voruciclib will be administered orally
  • voruciclib and venetoclax — DRUG
    Voruciclib and Venetoclax will be administered orally

Study Details

This is a Phase 1, open-label, dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML

Key Dates

Start date
May 31, 2018
Status verified
Mar 2026
Primary completion
Jul 24, 2024
Completion
Jul 24, 2024

Study Design

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

Arms

  • Experimental: voruciclib monotherapy and voruciclib in combination with venetoclax
    voruciclib monotherapy - Open-label, 3 + 3 dose escalation study which may enroll up to 6 subjects at each dose level and disease type (AML or B-cell malignancies) voruciclib and venetoclax - Open-label, 3 + 3 dose escalation study which may enroll up to 6 subjects at each dose level for AML subjects

Primary Outcome Measure

Determine the safety and tolerability of voruciclib [ Time Frame: 2 years ]

Locations (12)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Northwestern Memorial HospitalChicagoIllinois60611-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Mayo ClinicRochesterMinnesota55905-
University of Nebraska Medical CenterOmahaNebraska68198-
New York UniversityNew YorkNew York10016-
Duke UniversityDurhamNorth Carolina27705-
Oregon Health and Science UniversityPortlandOregon97239-
MD AndersonHoustonTexas77030-
University of VirginiaCharlottesvilleVirginia22903-
Swedish Cancer InstituteSeattleWashington98104-
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CANorthwestern Memorial Hospital· Chicago, ILDana Farber Cancer Institute· Boston, MAMayo Clinic· Rochester, MNUniversity of Nebraska Medical Center· Omaha, NENew York University· New York, NY

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