RECRUITING

A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or 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)B-Cell Malignancies, AML, voruciclib, venetoclax, CDK Inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2018-05-31

Study Completion:2025-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03547115

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

MEI Pharma

CONTACT

858-369-7100

Patients@meipharma.com

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

Northwestern Memorial Hospital

Chicago, Illinois, 60611

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

New York University

New York, New York, 10016

United States

Duke University

Durham, North Carolina, 27705

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

MD Anderson

Houston, Texas, 77030

United States

University of Virginia

Charlottesville, Virginia, 22903

United States

Swedish Cancer Institute

Seattle, Washington, 98104

United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: MEI Pharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-31

Study Completion Date2025-03-31

Study Record Updates

Study Start Date2018-05-31

Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

B-Cell Malignancies, AML, voruciclib, venetoclax, CDK Inhibitor

Additional Relevant MeSH Terms

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)