A Prospective Multicenter Phase 2 Study of the Chemotherapy-Free Combination of the Intravenous Phosphatidylinositol-3-Kinase (PI3K) Inhibitor Copanlisib in Combination With Obinutuzumab in Patients With Previously Untreated Follicular Lymphoma (FL) and a High Tumor Burden (Alternative-C)

  • STATUS
    Recruiting
  • End date
    May 19, 2026
  • participants needed
    98
  • sponsor
    Ludwig-Maximilians - University of Munich
Updated on 3 June 2022
platelet count
remission
measurable disease
neutrophil count
follicular lymphoma
obinutuzumab
tumor burden

Summary

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.

Details
Condition Follicular Lymphoma
Treatment Obinutuzumab, Copanlisib
Clinical Study IdentifierNCT05387616
SponsorLudwig-Maximilians - University of Munich
Last Modified on3 June 2022

Eligibility

Yes No Not Sure

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
bulky disease at study entry according to the GELF criteria (nodal or extranodal mass > 7 cm in its greatest diameter)
B symptoms (fever, drenching night sweats, or unintentional weight loss of > 10% of normal body weight over a period of 6 months or less)
hematopoietic insufficiency (granulocytopenia < 1500/µl, Hb < 10 g/dl, thrombocytopenia < 100000/µl)
compressive syndrome or high risk for compression syndrome
pleural/peritoneal effusion
symptomatic extranodal manifestations
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
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1500/µl
Platelet count ≥ 75000/µl
Women are not breast feeding, are using highly effective contraception (see section
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
non-melanoma skin cancer or adequately treated in carcinoma in situ of the cervix
other malignant diseases not specified above which have been curatively treated by surgery alone and from which subject is disease-free for ≥ 5 years without further treatment
Serious disease interfering with a regular therapy according to the study protocol
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
pulmonary (e.g. chronic lung disease with hypoxemia)
endocrine (e.g. severe, not sufficiently controlled diabetes mellitus)
renal insufficiency (unless caused by the lymphoma): creatinine > 2x normal value and/or creatinine clearance < 50 ml/min)
impairment of liver function (unless caused by the lymphoma): transaminases > 3x normal or bilirubin > 2.0 mg/dl (unless caused by known Morbus Meulengracht [Gilbert-Meulengracht-Syndrome])
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
Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology
testing) Patients positive for HCV antibody are eligible only if PCR is negative for
HCV RNA
Clinically significant history of liver disease, including viral or other hepatitis
or cirrhosis
Known history of HIV seropositive status
Patients with a history of confirmed PML
Vaccination with a live vaccine within 28 days prior to registration
Recent major surgery (within 4 weeks prior to the start of Cycle 1)
History of stroke or intracranial hemorrhage within 6 months prior to registration
Serious underlying medical conditions, which could impair the ability of the patient
to undergo the treatment offered in the study (e.g. ongoing infection, gastric ulcers
active autoimmune disease)
Treatment within another clinical study within 30 days prior to study entry
Prior organ, bone marrow, or peripheral blood stem cell transplantation
Known or persistent abuse of medication, drugs, or alcohol
Any other co-existing medical or psychological condition that will preclude
participation in the study or compromise ability to give informed consent
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