Universitätsklinikum Ulm | Innere Medizin III
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About
The Alternative-C Trial is a prospective, multicenter Phase 2 Study to evaluate the efficacy of the chemotherapy-free combination of copanlisib and obinutuzumab in patients with previously untreated follicular lymphoma (FL) and a high tumor burden. Additionally, the combination should be evaluated in terms of secondary efficacy endpoints, treatment compliance, safety and patient-reported symptoms. The study Population includes Patients > 18 years of age with histologically confirmed follicular lymphoma grade 1, 2 or 3A with Ann Arbor Stage III/IV or stage II not suitable for radiotherapy and in need of therapy.
Enrollment
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Inclusion criteria
Subjects will only be included in the study, if they meet all of the following criteria:
Histologically confirmed follicular lymphoma grade 1, 2 or 3A with a biopsy performed within 12 months before study entry and with material available for central review and complementary scientific analyses
Ann Arbor stage III/IV, or stage II not suitable for radiotherapy, or stage II bulky disease
Age ≥ 18 years
No prior lymphoma therapy
Need for start of therapy as defined by at least one of the following criteria:
At least one bi-dimensionally measurable lesion (> 2 cm in its largest dimension by CT scan or MRI)
Performance status ≤ 2 on the ECOG scale
Adequate hematologic function (unless abnormalities are related to NHL), defined as follows:
Women are not breast feeding, are using highly effective contraception (see section 11.4.1), are not pregnant, and agree not to become pregnant during participation in the study and during the 18 months thereafter (pregnancy testing is mandatory for premenopausal women).
Men agree not to father a child during participation in the study and during the 18 months thereafter.
Written informed consent
Exclusion criteria
Subjects will not be included in the study if any of the following criteria apply:
Transformation to high-grade lymphoma (secondary to "low grade" FL)
Grade 3B follicular lymphoma
Presence or history of CNS disease (either CNS lymphoma or leptomeningeal lymphoma)
Known hypersensitivity to any of the study drugs
Known sensitivity to murine products
Patients with HbA1c > 8.5 % at Screening
Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment)
Regular use of corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 20 mg/day prednisone or administered as prephase treatment according to study protocol (see section 7.2 of study protocol)
Concomitant use of strong CYP3A4 inhibitors and/or inducers
Prior or concomitant malignancies except:
Serious disease interfering with a regular therapy according to the study protocol:
Positive test results for chronic HBV infection (defined as positive HBsAg serology) Patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing.
Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination or prior but cured hepatitis B are eligible.
Primary purpose
Allocation
Interventional model
Masking
98 participants in 1 patient group
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Central trial contact
Sabine Witt; Michael Unterhalt, Dr.
Data sourced from clinicaltrials.gov
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