Evaluation of the efficacy and toxicity of GA 101 versus GA 101 plus Bendamustin, followed by GA 101 in medically non-fit patients < 60 years and in all patients = 60 years as first line therapy of advanced stage follicular lymphoma MedDRA version: 21.1 Level: PT Classification code 10016908 Term: Follicle centre lymphoma, follicular grade I, II, III stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Class
Conditions
Interventions
Trade Name: Gazyvaro®
Product Name: Gazyvaro®, Obinutuzumab®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OBINUTUZUMAB
CAS Number: 949142-50-1
Other descriptive name
Sponsors
Klinikum der Universität München
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - „Medically non-fit“ patients 2 or ECOG 0-2 with co-morbidities excluding intensive therapy according to local investigator’s discretion - All patients = 60 years in case of decision of investigator and patient to apply a reduced Treatment - Documentation of the CIRS-G, G8, IADL and ECOG Scores before start of treatment - Histologically confirmed follicular lymphoma grade I, II or IIIa with material available for central pathology review. - Stage III/IV and stage II without the option of curative radiotherapy - Age > 18 years - No prior therapy - Presence of at least one of the following symptoms or conditions requiring initiation of treatment: - Bulky disease according to the GELF criteria: nodal or extranodal mass > 7cm in its greater 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 (at least one of the following: granulocytopenia 1,5 cm in its largest dimension by CT scan or MRI) - 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 who are not breast feeding, are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 18 months thereafter. - Men who agree not to father a child during participation in the trial and during the 18 months thereafter. - Written informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
Exclusion criteria: - Medically fit” patient 3.0 mg/dl) - Known sensitivity or allergy to murine products - Known hypersensitivity to any of the study drugs - Treatment within a clinical lymphoma trial within 30 days prior to trial entry - Positive test results for chronic HBV infection (defined as positive HBsAg serology) (mandatory testing) 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 (mandatory hepatitis C virus [HCV] antibody serology testing) Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA. - Known history of HIV seropositive status. - Patients with a history of confirmed PML - Vaccination with a live vaccine within 28 days prior to registration - Prior organ, bone marrow or peripheral blood stem cell transplantation - Any other co-existing medical or psychological condition that will preclude participation in the study or compromise the ability to understand its nature, meaning and implications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: The objective of this study is to test the efficacy and toxicity of a combined OBINUTUZUMAB/bendamustine therapy or single agent OBINUTUZUMAB in younger (< 60 years) medically non-fit, ‘compromised’ patients and in all older patients (= 60 years) i. For the assessment of the anti-lymphoma activity the “overall response rate (ORR)” will be applied as primary endpoint. Overall response is defined as complete or partial response after 19 – 21 weeks ;Secondary Objective: Secondary objectives are to compare OBINUTUZUMAB/bendamustine with single agent OBINUTUZUMAB in terms of additional measures of anti-lymphoma activity, treatment related toxicities, treatment compliance, quality of life, and comorbidities, and the evaluation of geriatric and co-morbidity scores in the included medically non-fit FL population.;Primary end point(s): Overall response rate (ORR) defined as complete or partial response after 19-21 weeks.;Timepoint(s) of evaluation of this end point: Staging at week 19-21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? event free survival (EFS) ? CR Rate Time to Treatment Failure (TTF) ? Progression-free survival (PFS) ? Duration of Remission (RD) ? Time to next anti-lymphoma treatment ? Overall Survival (OS) ? Toxicities ? Frequency and Duration of Hospitalization ? Supportive Care ? Incidence of secondary transformation to aggressivelymphoma ? Incidence of secondary malignancies ? Treatment Compliance ? Quality of Life analysis (QoL) ? Geriatric and Comorbidity Scores lymphoma Incidence of secondary malignancies Treatment Compliance Quality of Life analysis (QoL) Geriatric and Comorbidity Scores;Timepoint(s) of evaluation of this end point: Staging at week 19-21 and 4-6 weeks after completion of the last OBINUTUZUMAB application (week 49-51). Follow-Up evaluation every three months during the first year and then every 6 months the subsequent years until documentation of disease progression or death. | — |
Countries
Germany
Contacts
Public ContactStudienzentrale für Hämatologie
Klinikum der Universität München, Med Klinik III
Outcome results
None listed