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Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT03207555
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : July 12, 2022
Pharmacyclics LLC.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The standard approach to managing chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) is to wait until you have symptoms before treatment is given.

The goal of this clinical research study is to learn if providing earlier treatment for CLL or SLL with ibrutinib in patients who do not have symptoms will be more effective than waiting until symptoms develop.

This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of patients with CLL or SLL. It is considered investigational to give ibrutinib to CLL and SLL patients before symptoms develop.

The study doctor can describe how the study drug is designed to work.

Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

Condition or disease Intervention/treatment Phase
Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic Chronic Lymphocytic Leukemia Small Lymphocytic Leukemia Drug: Ibrutinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ibrutinib Monotherapy in Early Stage Chronic Lymphocytic Leukemia (CLL) Without IWCLL/NCI-WG 2008 Treatment Indications But With High-Risk Features for Disease Progression
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Arm Intervention/treatment
Experimental: Ibrutinib
Participants take Ibrutinib by mouth 1 time every day for up to 2 years (24 cycles).
Drug: Ibrutinib
420 mg by mouth once daily.
Other Names:
  • PCI-32765
  • Imbruvica

Primary Outcome Measures :
  1. Complete Remission (CR) with Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL) [ Time Frame: 2 years ]
    Response assessed according to the IWCLL/NCI-WG 2008 criteria.

  2. Complete Remission with Incomplete Count Recovery (CRi) with Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL) [ Time Frame: 2 years ]
    Response assessed according to the IWCLL/NCI-WG 2008 criteria.

Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) with Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL) [ Time Frame: 2 years ]
    Response assessed according to the IWCLL/NCI-WG 2008 criteria.

  2. Overall response rate (ORR) of Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL) [ Time Frame: 6, 12 and 24 months ]
    Response assessed according to the IWCLL/NCI-WG 2008 criteria.

Information from the National Library of Medicine

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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:

  1. Patients must be age >/=18 years at the time of informed consent, understand and voluntarily sign an informed consent, and be able to comply with study procedures and follow-up examinations.
  2. No treatment indication according to IWCLL/NCI-WG (International Working Group in Chronic Lymphocytic Leukemia/National Cancer Institute-Working Group) 2008 criteria
  3. Estimated time to first treatment of 3 years or less according to MDACC nomogram
  4. ECOG performance status of 0-2
  5. Male and female subjects who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence , or sterilized partner) and a barrier method (eg., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug for females and 90 days for males. OR Female subjects who are of non-reproductive potential (ie, post-menopausal by history - no menses for >/=1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy)
  6. Adequate hepatic and renal function as indicated by all of the following: Total bilirubin </=1.5 x institutional Upper Limit of Normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease or of non-hepatic origin who will be allowed to participate, provided bilirubin is </=3 x institutional ULN; an ALT </=2.5 x ULN; and estimated creatinine clearance (CrCl) of > 30 mL/min, as calculated by the Cockcroft- Gault equation.
  7. PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder).
  8. Free of prior malignancies for 3 years with exception of patients diagnosed with basal cell or non-metastatic squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast, who are eligible even if they are currently treated or were treated and/or diagnosed in the past 3 years prior to study enrolment
  9. Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria

Exclusion Criteria:

  1. Receipt of any prior therapy for CLL. Patients who have received "early intervention" with INVAC-1 vaccine against hTERT will be eligible provided all of the following exist: i) They had no response to the vaccine treatment (persistent CLL >1% in bone marrow). ii) ≥3 months have elapsed since the last dose of vaccine. iii) No residual toxicities attributable to the vaccine exist at the time of study enrollment. iv) The patient does not meet IWCLL criteria for requiring treatment.
  2. Richter Transformation
  3. Active malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
  4. Systemic anticoagulation with warfarin or other Vitamin K antagonists
  5. Active and uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP) requiring daily prednisone dose of >/=20 mg
  6. Current and concurrent use of strong CYP3A4 inhibitors or inducers
  7. Pregnant or breast-feeding females
  8. Uncontrolled and active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
  9. Any other severe concurrent disease, or history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that, in the investigator's opinion, may place the patient at undue risk to undergo therapy with ibrutinib
  10. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
  11. History of ischemic stroke within 6 months prior to enrollment
  12. Evidence of bleeding diathesis or coagulopathy within 3 months (eg, von Willebrand's disease or hemophilia
  13. Any history of symptomatic intracranial hemorrhage
  14. Major surgical procedure with 4 weeks of first dose of study drug; open biopsy, or significant traumatic injury within 7 days prior to enrollment date; anticipation of need for major surgical procedure during the course of the study
  15. Minor surgical procedures, fine needle aspirations or core biopsies within 3 days prior to enrollment date. Bone marrow aspiration and/or biopsy are allowed
  16. Serious, non-healing wound, ulcer, or bone fracture
  17. Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
  18. Active, uncontrolled infection
  19. Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded
  20. Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification (see Appendix L)

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): NCT03207555

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pharmacyclics LLC.
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Principal Investigator: Philip A. Thompson, MBBS M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03207555    
Other Study ID Numbers: 2017-0039
NCI-2018-01121 ( Registry Identifier: NCI CTRP Clinical Trials Reporting Registry )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms stated as primary lymphoid haematopoietic
Chronic Lymphocytic Leukemia
Small Lymphocytic Leukemia
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell