A clinical trial of NOX-A12 in patients with chronic lymphocytic leukemia who have been previously treated and who will be receiving bendamustine and rituximab treatment

Phase 1

Conditions: Relapsed chronic lymphocytic leukemia
MedDRA version: 15.0Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2011-004672-11-BE

Lead Sponsor: OXXON Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 33

Inclusion Criteria

1. Male of female, age = 18
2. Diagnosis of B cell CLL
3. Relapsed, bendamustine-sensitive (at least partial response with a duration of at least six months) or bendamustine-naive patients after at least one but not more than 3 prior treatments of their disease.
4. CLL in need of treatment (Binet C or A/B with active disease) according to the IWCLL guidelines
5. Subject must have measurable disease according to IWCLL guidelines
6. Pre-study WHO performance status of = 2 and modified cumulative illness rating scale (CIRS) of less than 7
7. Signed and dated, written informed consent
8. Men and women of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment. Medically acceptable methods of birth control are methods with a low failure rate of less than 1% per year; e.g. hormonal contraceptives for at least the 7 days before trial enrolment or an interuterine device, or double barrier method (male or female condom or diaphragm, in combination with a spermicidal gel). All women, including those with tubal ligation, are considered to be of childbearing potential unless they have been postmenopausal for at least 2 years. Hysterectomized women are considered surgically sterile and are not required to use any contraception.
9. Acceptable liver function at screening: bilirubin =1.5 x ULN, AST and/or ALT = 2.5 x ULN
10. Acceptable heamatological status: platelet count = 75 x10 9/L, ANC > 0.75 x 10 9/L
11. Acceptable renal function: serum creatinine =1.5 ULN and/or creatinine clearance = 50 ml/min (Cockcroft Gault formula)
12. No clinical significant abnormalities of liver volume, liver heamodynamics or elasticity, measured by abdominal ultrasound.
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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

1. Relapse of B-cell CLL within 6 months after last chemotherapy
2. Subjects who have progressed to more aggressive B-cell cancers such as Richter's syndrome
3. CLL with either deletion of the short arm of chromosome 17 (17p-) or mutations associated with the loss of p53
4. The subject has a history of or is clinically suspicious of cancer related CNS disease
5. Patients at risk of hemostasis or spleen rupture
6. Autoimmune hemolytic anemia
7. Prior allogeneic stem cell transplant or patients who are considered to be candidates for allo SCT as assessed by their treating physician
8. Patient has a history of other active malignancies within three years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confirmed and surgically resected with curative intent.
9. The patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection (viral, bacterial or fungal); diagnosis of fever and neutropenia within 1 week prior to study drug administration
10. Female subject is pregnant or breast feeding
11. Known infection with HIV, active Hepatitis B or Hepatitis C
12. The patient has a history of prior toxicity from bendamustine or rituximab that resulted in permanent discontinuation of treatments.
13. Treatment with other investigational drugs, or participation in another clinical trial within 30 days prior to study drug administration
14. Uncontrolled hypertension (defined as systolic blood pressure (BP) > 160 mmHg or diastolic BP >100mmHg)
15. Myocardial infarction or unstable angina within the past 6 months prior to study drug administration. Heart failure of New York Heart Association functional Class III or IV prior to study drug administration.
16. Systemic illnesses or other severe concurrent disease including alcoholism which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and efficacy of the investigational treatment
17. Known or suspected of not being able to comply with the trial protocol
18. Having previously enrolled in this clinical trial
19. Known hypersensitivity to rituximab or to any of the excipients or to murine proteins
20. History of recurring or chronic infections or underlying conditions which may further predispose patients to serious infection
21. Known hypersensitivity to bendamustine or to mannitol
22. Invasive surgery within 30 days prior to study drug administration

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

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