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

Description

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

Conditions

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

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Study Overview

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Study Details

Study overview

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

Phase 1, Open-label, Study of Voruciclib in Subjects With Relapsed and/or Refractory B Cell Malignancies or AML After Failure of Prior Standard Therapies and Voruciclib in Combination With Venetoclax in Subjects With Relapsed/Refractory AML

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

Condition
Follicular Lymphoma (FL)
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

New York

New York University, New York, New York, United States, 10016

Durham

Duke University, Durham, North Carolina, United States, 27705

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

Houston

MD Anderson, Houston, Texas, United States, 77030

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥18 years
  • * Histologically-confirmed diagnosis of Follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia(CLL), diffuse large B-cell lymphoma (DLBCL), or AML
  • * Presence of measurable disease defined per the 2008 International workshop on CLL guidelines, or by 2014 Lugano criteria for non-Hodgkin lymphoma (does not apply for AML subjects)
  • * Adequate hematologic parameters unless clearly due to the disease under study
  • * Adequate renal and hepatic function, per laboratory reference range at screening
  • * History of pneumonitis of any cause
  • * For CLL subjects: only known histological transformation to an aggressive lymphoma
  • * For AML subjects:
  • 1. Acute promyelocytic leukemia
  • 2. Peripheral blast count \> 25 × 10 9/L
  • * Known central nervous system involvement
  • * Significant cardiovascular disease
  • * Significant screening ECG abnormalities
  • * Subjects who require warfarin, anti-cancer therapeutics or investigational agents
  • * Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the time of start of voruciclib therapy
  • * Prior solid organ transplantation
  • * Receipt of an allogeneic transplant within 6 months or an autologous transplant within the preceding 3 months; evidence of ongoing graft-versus-host disease (GVHD)
  • * Prior therapy with a cyclin-dependent kinase (CDK9) inhibitor
  • * Symptomatic/uncontrolled HIV infection/AIDS, or currently taking contraindicated medications for HIV control
  • * Ongoing immunosuppressive treatment including calcineurin inhibitors at the time of the start of study treatment, including systemic or enteric corticosteroids except as follows:
  • 1. Prior to the start of study treatment, subjects may be using systemic corticosteroids (≤20 mg/day of prednisone or equivalent), topical, or inhaled corticosteroids
  • 2. During study therapy, subjects may use systemic, topical, or enteric corticosteroids, if needed

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MEI Pharma, Inc.,

Study Record Dates

2025-03-31