A Phase 1 Study of Voruciclib in Subjects With B-Cell Malignancies or AML
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ClinicalTrials.gov Identifier: NCT03547115 |
Recruitment Status :
Recruiting
First Posted : June 6, 2018
Last Update Posted : January 20, 2022
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Condition or disease | Intervention/treatment | Phase |
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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) | Drug: voruciclib | Phase 1 |
This is a Phase 1, open-label, 3 + 3 dose escalation study to determine the safety and preliminary efficacy of voruciclib in subjects with relapsed/refractory B cell malignancies and AML after treatment with standard therapy. Escalation to the next higher dose level will depend on demonstrated safety and tolerability at each dose level.
Subjects may continue to receive voruciclib while there is evidence of clinical benefit and acceptable toxicity as judged by the investigator.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 92 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | This is a Phase 1, open-label, 3 + 3 dose escalation study to determine the safety and preliminary efficacy of voruciclib. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-label, Study of Voruciclib in Subjects With Relapsed and/or Refractory B Cell Malignancies or Acute Myeloid Leukemia After Failure of Prior Standard Therapies |
Actual Study Start Date : | May 31, 2018 |
Estimated Primary Completion Date : | April 30, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

Arm | Intervention/treatment |
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Experimental: voruciclib
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)
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Drug: voruciclib
Voruciclib is provided as 50 mg and 100 mg capsules and is administered orally once a day |
- Determine the safety and tolerability of voruciclib [ Time Frame: 2 years ]
Safety will be measured by the incidence of all AEs and SAEs, timing, grade [CTCAE v4.03] severity, seriousness, relatedness.
Tolerability will be measured by the incidence of DLTs (dose limiting toxicities)
- Overall Response Rate (ORR) [ Time Frame: 2 years ]defined as the sum of complete response (CR), complete remission with incomplete marrow recovery (CRi) and partial response (PR) for B-cell malignancies, or for AML the sum of CR/CRi rate by the 2017 European LeukemiaNet (ELN) criteria
- Duration of Response (DOR) [ Time Frame: 2 years ]defined as the time from the initial determination of response to the time of disease progression or death on study, which ever occurs first
- Rate of CR/CRi [ Time Frame: 2 years ]defined as the proportion of subjects with CR and CRi (i.e 2 CRs or CRis at least 28 days apart) according to IWG criteria
- Progression Free Survival (PFS) [ Time Frame: 2 years ]defined as the time from the first dose of study drug administration (Cycle 1 Day 1) to disease recurrence or progression as defined by IWG criteria, or death on study
- Evaluate the PK of voruciclib [ Time Frame: 2 years ]Determined by the Area Under the Concentration time curve (AUC)
- Evaluate the PK of voruciclib Cmax [ Time Frame: 2 years ]Determined by Peak Plasma Concentration (Cmax)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥18 years
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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
a. Subjects must have disease that has relapsed or is refractory to 2 or more prior regimens and in need of treatment due to progressive disease
- 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
Exclusion Criteria:
- History of pneumonitis of any cause
- For CLL subjects: only known histological transformation to an aggressive lymphoma
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For AML subjects:
- Acute promyelocytic leukemia
- 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
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Ongoing immunosuppressive treatment at the time of the start of voruciclib therapy, including systemic or enteric corticosteroids except as follows:
- Prior to the start of voruciclib therapy, subjects may be using systemic corticosteroids (≤20 mg/day of prednisone or equivalent), topical, or inhaled corticosteroids
- During study therapy, subjects may use systemic, topical, or enteric corticosteroids, if needed

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547115
Contact: MEI Pharma | 858-369-7100 | Patients@meipharma.com |
United States, California | |
City of Hope | Recruiting |
Duarte, California, United States, 91010 | |
United States, Illinois | |
Northwestern Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
United States, Nebraska | |
University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198 | |
United States, New York | |
New York University | Recruiting |
New York, New York, United States, 10016 | |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27705 | |
United States, Oregon | |
Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
MD Anderson | Recruiting |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Swedish Cancer Institute | Recruiting |
Seattle, Washington, United States, 98104 | |
United States, Wisconsin | |
Froedtert Hospital & the Medical College of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53226 |
Responsible Party: | MEI Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT03547115 |
Other Study ID Numbers: |
ME-522-001 |
First Posted: | June 6, 2018 Key Record Dates |
Last Update Posted: | January 20, 2022 |
Last Verified: | January 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
B-Cell Malignancies, AML, voruciclib, Cyclin Dependent Kinase Inhibitor |
Lymphoma Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Leukemia, Lymphoid Lymphoma, B-Cell Leukemia, B-Cell Voruciclib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |