A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination with Obinutuzumab or Acalabrutinib With Different Ramp-Up Periods in Previously Untreated Subjects with CLL

Conditions

Chronic Lymphocytic Leukemia

Brief summary

Part 1: Incidence of treatment-emergent laboratory TLS or treatment-emergent hyperkalemia per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment, Reduction of Tumor Burden from Baseline

Detailed description

Part 1: The incidence of treatment-emergent laboratory TLS or treatment-emergent hyperkalemia per Howard criteria that require a clinical intervention that has confirmed by an IRC assessment, Part 1: Incidence of Laboratory TLS per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment, Part 1: Incidence of Hyperkalemia per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment, Part 1: Incidence of Laboratory TLS per Howard criteria irrespective of clinical intervention, Part 1: Incidence of Hyperkalemia irrespective of clinical intervention, Part 1: Incidence of Clinical TLS per Howard criteria irrespective of clinical intervention, Part 1: Incidence of any single TLS-related lab abnormality requiring clinical intervention per Investigator (Hyperuricemia or Hyperphosphatemia or Hyperkalemia or Hypocalcemia), Adverse Events (AE) of TLS, Reduction of tumor burden from baseline

Related papers

No related papers found yet.

Interventions

DRUGVenetoclax

DRUGGazyvaro 1

DRUG000 mg concentrate for solution for infusion.

DRUGCalquence 100 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: Incidence of treatment-emergent laboratory TLS or treatment-emergent hyperkalemia per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment, Reduction of Tumor Burden from Baseline	—

Secondary

Measure	Time frame
Part 1: The incidence of treatment-emergent laboratory TLS or treatment-emergent hyperkalemia per Howard criteria that require a clinical intervention that has confirmed by an IRC assessment, Part 1: Incidence of Laboratory TLS per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment, Part 1: Incidence of Hyperkalemia per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment, Part 1: Incidence of Laboratory TLS per Howard criteria irrespective of clinical intervention, Part 1: Incidence of Hyperkalemia irrespective of clinical intervention, Part 1: Incidence of Clinical TLS per Howard criteria irrespective of clinical intervention, Part 1: Incidence of any single TLS-related lab abnormality requiring clinical intervention per Investigator (Hyperuricemia or Hyperphosphatemia or Hyperkalemia or Hypocalcemia), Adverse Events (AE) of TLS, Reduction of tumor burden from baseline	—

Measure

Time frame

Part 1: The incidence of treatment-emergent laboratory TLS or treatment-emergent hyperkalemia per Howard criteria that require a clinical intervention that has confirmed by an IRC assessment, Part 1: Incidence of Laboratory TLS per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment, Part 1: Incidence of Hyperkalemia per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment, Part 1: Incidence of Laboratory TLS per Howard criteria irrespective of clinical intervention, Part 1: Incidence of Hyperkalemia irrespective of clinical intervention, Part 1: Incidence of Clinical TLS per Howard criteria irrespective of clinical intervention, Part 1: Incidence of any single TLS-related lab abnormality requiring clinical intervention per Investigator (Hyperuricemia or Hyperphosphatemia or Hyperkalemia or Hypocalcemia), Adverse Events (AE) of TLS, Reduction of tumor burden from baseline

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Countries

France, Greece, Spain

Outcome results

None listed