BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia

Exclusion Criteria

• •1. Allogenic bone marrow transplant within 12 months prior to the first dose of BI-1206 or presence of chronic graft versus host disease.
• •2. Patients with clinically active leptomeningeal or central nervous system lymphoma/leukaemia.
• •3. Doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) are not permitted whilst on the study other than as pre-medication. During the screening period, doses of up to 20 mg per day may be given but the dose must be reduced to 10 mg/day by Cycle 1 Day 1 (or Day -7 in the CLL combination expansion).
• •4. Known or suspected hypersensitivity to study drugs.
• •5. Cardiac or renal amyloid light-chain (AL) amyloidosis.
• •6. Radiotherapy, endocrine therapy, immunotherapy, chemotherapy or investigational medicinal products during the previous 4 weeks before treatment.
• •7. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the Sponsor should not exclude the patient.
• •8. Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one highly effective form plus a barrier method) \[oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom\] or agree to sexual abstinence\^4 for four weeks before entering the trial, during the trial and for twelve months after completing treatment are considered eligible.
• •9. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception \[condom plus spermicide\] or to sexual abstinence effective from the first administration of BI-1206 or rituximab on the study, throughout the trial and for twelve months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence4). Men with pregnant or lactating partners should be advised to use barrier method contraception (e.g. condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
• •10. Major thoracic or abdominal surgery from which the patient has not yet recovered.
• •11. At high medical risk because of non-malignant systemic disease including infection.
• •12. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
• •13. Patients with an active, known or suspected autoimmune disease (not including CLL auto-immune disease). Patients with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger will be permitted to participate.
• •14. Concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association \[NYHA\]), prior history of cardiac ischaemia or prior history of cardiac arrhythmia.
• •15. Patients for whom rituximab is contraindicated due to severe previous hypersensitivity or any other reason (Arm 2 in Parts A and B \[combination arms\] only).
• •16. Ongoing infection requiring treatment with antibiotics, antifungals or antivirals. Prophylactic use of antibiotics, antifungals or antivirals would not have excluded patients.
• •17. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
• •18. Is a participant or plans to participate in another interventional clinical study, whilst taking part in this Phase I/IIa study of BI-1206. Participation in an observational study would be acceptable.
• •19. Current malignancies of other types, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial.