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Phase I Study of Lenalidomide, Rituximab and Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

This study has been terminated.
(Recruitment difficulties)
ClinicalTrials.gov Identifier:
First Posted: July 25, 2014
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Georgetown University

This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on patients with CLL/SLL.

The hypothesis of the study is that it will be safe to give the three drugs in combination and the information learned from this trial will be used to study the 3 drug combination is a larger future trial.

Condition Intervention Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Drug: Lenalidomide, Ibrutinib, Rituximab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Lenalidomide in Combination With Rituximab and Ibrutinib in Relapsed and Refractory CLL and SLL

Resource links provided by NLM:

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Recommended Phase II dose [ Time Frame: 1year ]
    The dose at which less than 2 of 6 patients experience a dose limiting toxicity

Secondary Outcome Measures:
  • Safety [ Time Frame: 2 years ]
    adverse events, serious adverse events, adverse events leading to discontinuation, deaths

  • Antitumor efficacy [ Time Frame: 2 years ]
    Proportion of patients who achieve stable disease, partial or complete response; progression-free survival defined as duration of time from start of treatment to time of progression or death

Enrollment: 5
Study Start Date: April 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide, Ibrutinib, Rituximab
Rituximab on day 1, lenalidomide days 1-21 and ibrutinib continuously for 6 cycles or until disease progression or intolerance to the combination. Single agent ibrutinib will then be continued until disease progression or intolerance.
Drug: Lenalidomide, Ibrutinib, Rituximab
Dose level -2 Ibrutinib 280 mg; Lenalidomide 2.5 mg; Rituximab 375 mg/m2 Level -1 Ibrutinib 420 mg; Lenalidomide 2.5 mg; Rituximab 375 mg/m2 Level 1 Ibrutinib 420 mg; Lenalidomide 5 mg; Rituximab 375 mg/m2 Level 2 Ibrutinib 420 mg; Lenalidomide 10 mg; Rituximab 375 mg/m2 Level 3 Ibrutinib 420 mg; Lenalidomide 15 mg; Rituximab 375 mg/m2
Other Names:
  • Ibrutinib
  • PCI-32765
  • NSC# 748645
  • Imbruvica
  • Lenalidomide
  • alpha-[3-aminophthalimido] glutarimide
  • Revlimid
  • CC-5013
  • NSC#703813
  • Rituximab
  • IDEC-C2B8
  • Rituxan

Detailed Description:
Treatment consists of dose escalations of lenalidomide and ibrutinib and fixed doses of rituximab. A small expansion cohort to include 10 patients will follow once the recommended phase II dose is found.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma that requires treatment
  • No prior systemic treatment within 4 weeks of enrollment
  • No corticosteroids within 2 weeks prior to study entry
  • Measurable disease must be present
  • No concomitant anti-cancer therapies
  • ECOG status </= 2
  • Patients with HIV infection are eligible
  • Patients with treated CLL or SLL in CNS are eligible
  • Non-pregnant and non-nursing
  • Life expectancy greater than 60 days
  • Adequate bone marrow, kidney and liver function
  • No major surgery within 28 days or minor surgery within 5 days of starting treatment

Exclusion Criteria:

  • History od Richter's transformation
  • History of prior allogeneic transplant
  • Radioimmunotherapy within 1 year of enrollment
  • Prior Bruton's tyrosine kinase inhibitor or lenalidomide
  • History of allergic reactions to compounds similar to ibrutinib, lenalidomide or rituximab or hypersensitivity
  • active or uncontrolled autoimmune hemolytic anemia or ITP
  • Transfusion-dependent thrombocytopenia or bleeding disorders
  • Active hepatitis B or C infections
  • History of known Human Anti-Chimeric Antibody positivity
  • History of erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome
  • History of uncontrolled seizures
  • Autoimmune disorder that requires active immunosuppression
  • Stroke or intracranial hemorrhage within last 6 months
  • History of congestive heart failure, myocardial infarction, unstable angina, uncontrolled arrhythmia or any Class 3 or 4 heart disease in the last 6 months
  • No prior malignancy except if treated with curative intent with no active disease for more than 3 years; adequately treated non-melanoma skin cancer or cervical cancer in situ
  • using warfarin or similar Vitamin K antagonists Unable to swallow capsules or disease significantly affecting gastrointestinal function or inhibiting small intestine absorption
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02200848

United States, District of Columbia
Georgetown Lombardi Comprehensive Cancer Center
Washington, D.C., District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
National Cancer Institute (NCI)
Principal Investigator: Chaitra Ujjani, MD Georgetown Lombardi Comprehsnive Cancer Center
  More Information

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02200848     History of Changes
Other Study ID Numbers: NCI#9540
First Submitted: July 22, 2014
First Posted: July 25, 2014
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Georgetown University:

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents