Ibrutinib in Treating Minimal Residual Disease in Patients With Chronic Lymphocytic Leukemia After Front-Line Therapy

NCT02649387 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: MC1481NCI-2015-0215315-004991
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the side effects and how well ibrutinib works in treating patients with chronic lymphocytic leukemia who responded to initial treatment used to reduce a cancer (front-line therapy) but have residual disease. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Conditions

Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Rate of Confirmed MRD-negative Response

  This outcome is summarized by the proportion of patients achieving MRD negative status. A confirmed MRD-negative response is defined as an achievement of MRD-negative status in both the blood and the bone marrow on two consecutive evaluations at least 3 months apart.

  3 years

Secondary Outcomes (6)

• Duration of MRD-negative Response

  5 years

• Improvement in Clinical Response

  Baseline to up to 5 years

• Incidence of Adverse Events

  Up to 30 days after the last day of study drug treatment

• Progression-free Survival

  Up to 5 years

• Time to MRD-negative Response

  5 years

Study Arms (1)

Treatment (ibrutinib)

EXPERIMENTAL

Patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks\* for up to 36 courses in the absence of disease progression or unacceptable toxicity. Note: \*The last course may last up to 56 days to accommodate the study drug discontinuation visit.

Drug: Ibrutinib; Other: Laboratory Biomarker Analysis

Interventions

Ibrutinib DRUG

Given PO

Also known as: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765

Treatment (ibrutinib)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (ibrutinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form
• Able to adhere to the study visit schedule and other protocol requirements including willing to provide blood, baseline bone marrow aspirate, and control deoxyribonucleic acid (DNA) samples for correlative research purposes
• Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL), confirmed by flow cytometry and as per the criteria outlined by the IWCLL/Hallek December 2008
• Prior frontline therapy for B-CLL must have been discontinued \>= 56 days but =\< 365 days prior to registration; NOTE: Patients on supportive care therapy due to use of specific induction regimen such as antibiotics may continue on those treatments at the discretion of the treating physician
• Patient must have completed a frontline induction therapy (minimum of 2 treatment cycles); NOTE: Standard therapies/therapeutic agents are defined as those listed in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of CLL; also, patients who received induction regimen as part of a clinical trial and is not necessarily mentioned in the NCCN guidelines, will also be eligible as long as the patient has completed at least 2 treatment cycles of induction regimen, achieved a clinical response (PR or CR) and is able to meet all other criteria for the study; however, patients who have previously received ibrutinib or have been randomized to ibrutinib containing arms in a clinical trial will not be eligible for this study
• Patients must have a sustained clinical response (PR, nodular PR \[nPR\], complete clinical response \[CCR\], CR with incomplete marrow recovery \[CRi\], CR) with documented residual disease (\>= 1 CLL cell per 10,000 leukocytes or \>= 0.01% MRD) either in the blood, bone marrow or a lymph node \>= 3.5 cm by any available techniques
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at registration
• Absolute neutrophil count \>= 1000/mm\^3
• Platelet count \>= 30,000/mm\^3
• Serum creatinine =\< 1.5 x upper limit of normal (ULN)
• Total bilirubin =\< 1.5 mg/dL or direct bilirubin =\< 1.0 mg/dL for patients with Gilbert's syndrome
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3.5 x ULN
• Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• Since this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown, any of the following will deem the subject ineligible for the study:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Use of any other experimental drug or therapy =\< 28 days prior to registration on this study; NOTE: Patients on low dose prednisone (=\< 10 mg) for treatment of conditions other than CLL are eligible
• Patients who have received more than 1 prior therapy; NOTE: Prior therapy is defined as any single agent or combination regimen that is included as treatment for symptomatic CLL; treatment(s) given prior to the symptomatic phase of the disease (preventive strategy) will not be considered as prior induction therapy; for the purpose of a particular therapy/regimen to be counted towards the number of prior treatments a patient must have received at least 2 cycles of the induction regimen e.g., a patient who change their treatment regimen after only 1 cycle (due to toxicity or any other reason) will not be considered to have "2" prior therapies
• Patients who have progressive disease or relapse (as defined by the IWCLL criteria) at or any time before registration on this study
• Patients with history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off therapy for that disease for \> 3 years)
• Patients who are already MRD- (both in the blood and the bone marrow) after frontline therapy and have lymph nodes \< 3.5 cm
• Concomitant use of warfarin or other vitamin K antagonists
• Requires treatment with a strong cytochrome P450 modulators (cytochrome P450, family 3, subfamily A \[CYP3A\] inhibitor and/or CYP3A inducers)
• Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
• Major surgery =\< 4 weeks prior to registration

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Asher Alban Chanan Khan
• Organization: Mayo Clinic

Chanan-Khan.Asher@mayo.edu

904-953-0450

Study Officials

• Asher Chanan-Khan, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Sikander Ailawadhi, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 7, 2016
• Study Start: February 8, 2016
• Primary Completion: December 14, 2023
• Study Completion: January 15, 2026
• Last Updated: February 10, 2026
• Results First Posted: July 24, 2025

Record last verified: 2026-01

Locations

US (1)