- Patient population In the dose escalation cohorts: Patients with pathologically confirmed B cell malignancy (i.e. DLBCL, CLL, small lymphocytic lymphoma [SLL], follicular lymphoma [FL], mantle cell lymphoma (MCL), Morbus Waldenström), with at least 1, but not more than 3 prior lines of therapy.
In the dose expansion cohort: Patients with relapsed/refractory DLBCL (ABC subtype) histo-pathologically confirmed by gene expression profiling (GEP) tested at a central laboratory or MCL with documented overexpression of either cyclin D1 or t(11;14), with at least 1, but not more than 3 prior lines of therapy, and measurable disease according to the Cheson criteria.
- Life expectancy of greater than 4 months from the first dose of M7583 and Eastern Cooperative Oncology Group (ECOG) performance status of less than equal to (<=) 2 at Screening
- Adequate hematological function in the absence of transfusions defined (within 6 weeks prior to first dose of study medication) defined by white blood cell (WBC) count greater than equal to (>=) 3 x 109/liter (L) with absolute neutrophil count (ANC) >= 1.0 x 109/L, platelet count >= 50 x 109/L, and haemoglobin >=9 gram per decilitre (g/dL).
- Adequate hepatic function defined by a total bilirubin level <= 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) <= 2.5 x ULN, and alanine aminotransferase (ALT) <= 2.5 x ULN.
- Adequate renal function defined by an estimated glomerular filtration rate (GFR) greater than (>) 45 milliliter per minute (mL/min) according to the 4-component Modification of Diet in Renal Disease (MDRD) equation. (GFR [mL/min/1.73 m2] = 175 x serum creatinine (Scr)-1.154 x age-0.203 x 1.212 [if African American] x 0.742 [if female]).
- Documented disease progression (based on Cheson and Halleck criteria) after the most recent treatment regimen.
- The patient must also agree to pretreatment and on-treatment tumor biopsies of an affected lymph node or bone marrow aspirates if bone marrow is involved.
- Adult male and female patients aged ≥ 18 years.
Previous exposure to any BTK inhibitor.
- Known central nervous system lymphoma or leukemia.
- History of Richter's transformation or prolymphocytic leukemia.
- Prior therapy with:
Anticancer treatment with chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or with any other anticancer therapy within 28 days prior to Cycle 1 Day 1 (C1D1) of trial drug treatment; (6 weeks for nitrosurea or mitomycin C).
Any investigational agent within 28 days prior to C1D1 of trial drug treatment.
- Not recovered from toxicity due to prior therapy, to pretherapy status or Grade 1 or less (except alopecia).
- Received surgical intervention within 21 days prior to C1D1 of M7583 treatment or received prior allogeneic stem cell transplant or autologous bone marrow transplantation within 6 months prior to first dose of M7583.
- Current significant cardiac conduction abnormalities, including corrected QT duration (QTc) prolongation of > 480 msec or a history of past or paroxysmal atrial fibrillation or significant cardiac arrhythmia.
- A history of cardiovascular/cerebrovascular disease as follows: not fully recovered cerebral vascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (less than (<) 6 months prior to enrolment), unstable angina or congestive heart failure (New York Heart Association Classification Class >= II).
- Current hypertension uncontrolled by medication.
- Concomitant treatment with non-permitted drugs, including but not limited, to warfarin or other Vitamin K antagonists.
Patients receiving medications, herbal supplements, or food known to be moderate or strong inhibitors of CYP3A within 7 days prior to the first dose of M7583, or moderate or strong inducers of CYP3A within 21 days prior to the first dose of M7583, or drugs mainly metabolized by CYP3A with a narrow therapeutic index that cannot be stopped before the first dose of trial treatment.
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|