A study to evaluate the efficacy and safety of ibrutinib and ofatumumab in untreated patients with chronic lymphocytic leukemia or small cell lymphocytic lymphoma.
- Conditions
- Chronic Lymphocytic Leukemia or Lymphocytic Small Cell Lymphoma without previous treatmentMedDRA version: 20.0Level: LLTClassification code 10051812Term: Small cell lymphocytic lymphomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004937-26-ES
- Lead Sponsor
- Fundación PETHEMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Physically fit patients with treatment-naïve chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
1. Adult patients with previously untreated CLL or SLL defined following IWCLL criteria (Hallek, 2008).
2. Must understand and voluntarily sign an informed consent form.
3. Age = 18 years at the time of signing the informed consent form and must be able to adhere to the study visit schedule and other protocol requirements.
4. Must have a documented diagnosis of CLL or SLL [IWCLL guidelines for diagnosis and treatment of CLL (Hallek, 2008)] meeting at least one of the following criteria:
• Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia.
• Massive (i.e. > 6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
• Massive nodes (i.e. > 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
• Progressive lymphocytosis with an increase of > 50% over a 2 month period, or lymphocyte doubling time (LDT) of less than 6 months.
• A minimum of any one of the following disease-related symptoms: unintentional weight loss = 10% within the previous 6 months, significant fatigue (i.e., ECOG PS 2; cannot work or unable to perform usual activities), fevers of greater than 38.0° C or 100.5F for 2 or more weeks without other evidence of infection, or night sweats for more than 1 month without evidence of infection.
5. Physically fit patients defined as CIRS < 6.
6. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of =2.
7. All sexually active subjects (male and female) must use accepted methods of barrier contraception (ie, condoms) during the course of the study and for 3 months after discontinuation of study treatments. (For women of childbearing potential and for men who can father a child, a second method of barrier contraception in addition to condom use is recommended).
8. Female subjects of childbearing potential must have a negative pregnancy test at screening. Females of child bearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42
1. Prior treatment for CLL or SLL.
2. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
3. Systemic infection that has not resolved prior to initiating study treatment in spite of adequate anti-infective therapy.
4. Pregnant or lactating females.
5. Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating study therapy.
6. Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
7. Prior history of malignancies, other than CLL, unless the patient has been free of the disease for = 3 years.
Exceptions include the following:
• Basal cell carcinoma of the skin
• Squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
8. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
9. Any of the following laboratory abnormalities:
• Serum creatinine = 2 x ULN or estimated Glomerular Filtration Rate (Cockroft GaultAppendix C) = 40 mL/min/1.73m2
• Absolute neutrophil count (ANC) < 1.0 X 10E9/L, unless secondary to bone marrow involvement by CLL.
• Platelet count <100,000/mm3 or <50,000/mm3 if bone marrow involvement independent of transfusion support in either situation
• Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetictransaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) >3 x upper limit of normal (ULN).
• Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert’s syndrome.
10. Presence of autoimmune haemolytic anemia or thrombocytopenia.
11. Disease transformation [i.e. Richter’s Syndrome (lymphomas) or prolymphocytic leukemia.
12. Major surgery within the last 28 days prior to registration.
13. History of stroke or intracranial haemorrhage within 6 months prior to enrolment.
14. Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 3 months prior to enrolment.
15. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 28 days of first dose of study drug.
16. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method