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Phase 2 Study of a CDK4/6 Inhibitor for Patients With Relapsed or Refractory Mantle Cell Lymphoma

Phase 2
18 Years
Open (Enrolling)
Mantle Cell Lymphoma

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Trial Information

Phase 2 Study of a CDK4/6 Inhibitor for Patients With Relapsed or Refractory Mantle Cell Lymphoma

Inclusion Criteria:

- Have a diagnosis of relapsed or refractory Mantle Cell Lymphoma (MCL) according to
the World Health Organization (WHO) classification that has relapsed after, or been
refractory to, available standard treatments. However, participants who are
intolerant of, or unable to receive a standard treatment are not required to have MCL
that has relapsed after, or been refractory to, that specific standard treatment.
Pathology must be reviewed and confirmed at the investigational site where
participant is entered prior to enrollment

- Have disease that is assessable according to the Response Criteria for Non- Hodgkin's

- Have given written informed consent prior to any study-specific procedures

- Have adequate organ function including:

- Hematologic: Absolute neutrophil count (ANC) ≥1.0 x 10^9/Liter (L), platelets
≥50 x 10^9/L, and hemoglobin ≥8 grams per deciliter (g/dL)

- Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN) and alanine
aminotransferase (ALT) ≤3.0 times ULN

- Renal: Estimated creatinine clearance ≥50 milliliter per minute (ml/min)

- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or

- Have discontinued all previous therapies for cancer (including chemotherapy,
radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for
myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving
study drug, and recovered from the acute effects of therapy (treatment-related
toxicity resolved to baseline) except for residual alopecia

- Are willing to make themselves available for the duration of the study and to follow
study procedures

- Are amenable to compliance with protocol schedules and testing

- Males and females with reproductive potential must agree to use medically approved
contraceptive precautions during the trial and for 3 months following the last dose
of study drug

- Females with child-bearing potential must have a negative serum pregnancy test within
14 days of the first dose of study drug

- Have a life expectancy of ≥12 weeks

- Are able to swallow capsules

Exclusion Criteria:

- Are currently enrolled in, or discontinued within 14 or 21 days of the initial dose
of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively, a
clinical trial involving an investigational product or non-approved use of a drug or
device other than the study drug used in this study, or concurrently enrolled in any
other type of medical research judged not to be scientifically or medically
compatible with this study

- Have serious preexisting medical conditions that, in the judgment of the
investigator, would preclude participation in this study (for example, pneumonia,
inflammatory bowel disease, history of major surgical resection involving the stomach
or small bowel)

- Have symptomatic metastasis to the central nervous system (CNS). Participants may
have CNS metastasis that is radiographically or clinically stable for at least 14
days prior to receiving study drug, regardless of whether they are receiving

- Have received an autologous or allogeneic stem-cell transplant within 75 days of the
initial dose of study drug. In addition, recipients of an allogenic stemcell
transplant must have discontinued immunosuppressive therapy at least 14 days before
study drug administration with no more than Grade 1 acute graft versus-host disease
on Day 1 of Cycle 1

- Females who are pregnant or lactating

- Have active bacterial, fungal, and/or known viral infection (for example, human
immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or
hepatitis C antibodies). Screening is not required for enrollment

- Have a baseline electrocardiogram (ECG) with any of the following findings:
ventricular tachycardia, ventricular fibrillation, abnormal QTcB (defined as ≥450
milliseconds for males and ≥470 milliseconds for females), or evidence of acute
myocardial ischemia

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Participants who Achieve Best Overall Disease Response of Complete Response (CR), Complete Response unconfirmed (CRu), Partial Response (PR) or Stable Disease (SD)

Outcome Time Frame:

Baseline until Disease Progression or Start of New Anticancer Therapy (Estimated up to 28 Months)

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

March 2013

Completion Date:

October 2014

Related Keywords:

  • Mantle Cell Lymphoma
  • Non- Hodgkins Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell