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Safety Study of CC-292 and Rituximab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety Study of CC-292 and Rituximab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Phase 1b, Multi-center, Open Label, Study to Determine the Safety and Activity of CC-292 in Combination With Rituximab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma.

NCT01744626•Celgene Corporation

View on ClinicalTrials.gov

Summary

This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and Rituximab in subjects with CLL.

Detailed Description

This dose finding study uses a 3 + 3 dose escalation and expansion design to establish the recommended Phase 2 dose (RP2D). Treatment will consist 28 day treatment cycles with a single Rituximab infusion per cycle for 6 cycles and twice daily (days 1-28) administration of CC-292 with a starting dose cohort of 375mg twice a day. Following safety review of the data from the initial cohort and confirmation that the initial dose is tolerable, the next dose level will be enrolled with a once per cycle Rituximab infusion for 6 cycles and twice daily CC-292 at 500 mg. Determination of the maximum tolerated dose and/or optimal biologic effect will be used to establish a dose for evaluation in an expansion cohort of 24 subjects. Evaluation of the data for subjects in the expansion cohorts will result in establishment of a RP2D.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female subjects 18 years of age and older at the time of signing the informed consent document.
•2. Understand and voluntarily sign an informed consent document (ICD) prior to any study related assessments/procedures being conducted.
•3. Able to adhere to the study visit schedule and other protocol requirements.
•4. Body weight ≥ 50 kg.
•5. Must have a documented diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (International Workshop) guidelines for the diagnosis and treatment of CLL (Appendix A), or lymphoma guidelines (Appendix B) for diagnosis and treatment of SLL by investigator assessment.
•6. Have failed ≥ 1 previous treatments for CLL/SLL, and have relapsed or refractory disease following last prior treatment.
•1. Refractory is defined as CLL/SLL that does not achieve at least a partial response (PR) to therapy or that progresses within 6 months of treatment. Relapsed CLL/SLL refers to disease that progresses after ≥ 6 months in subjects who had achieved a PR or complete response (CR) to therapy.
•2. Subjects must have failed, refused, be ineligible, or not otherwise appropriate, per the investigator's judgment, for autologous stem cell transplant (SCT) unless enrollment in this study is anticipated to debulk lesions in preparation for SCT.
•7. Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤ 2
•8. Life expectancy of at least 3 months form the time of signing the ICD.
+6 more criteria

Exclusion Criteria

•1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
•2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
•3. Any condition that confounds the ability to interpret data from the study.
•4. Autologous stem cell transplant within 3 months of screening date.
•5. Uncontrolled intercurrent illness including, but not limited to:
•1. Ongoing or active infection requiring parenteral antibiotics.
•2. Uncontrolled diabetes mellitus as defined by the investigator.
•3. Chronic symptomatic congestive heart failure (Class III or IV of the New York Heart. Association Classification for Heart Disease; AppendixG).
•4. Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months of signing the ICD.
•5. Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia. Subjects with controlled atrial fibrillation that is asymptomatic are eligible.
+35 more criteria

Locations (8)

Clearview Cancer Institute

Huntsville, Alabama, United States

Horizon Oncology Research, Inc

Lafayette, Indiana, United States

Hackensack UMC

Hackensack, New Jersey, United States

The West Clinic

Memphis, Tennessee, United States

Universitätsklinik Ulm

Ulm, Bavaria, Germany

Städt. Klinikum München-Schwabing

Bayern, Germany

Universitatsklinikum Wurzburg

Bayern, Germany

Universitätsklinik Köln

Cologne, Germany

Key Dates

Start Date

December 1, 2012

Primary Completion Date

December 1, 2015

Completion Date

December 1, 2015

Last Updated

April 19, 2016

Enrollment

ACTUAL participants

Conditions

Leukemia Lymphocytic Chronic B-Cell

Interventions

CC-292

DRUG

Rituximab

DRUG