GOAL: GA101 Plus Pixantrone for Relapsed Aggressive Lymphoma

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the overall response rate of Obinutuzumab (GA101) in combination with Pixantrone in patients with relapsed aggressive B-cell lymphoma. 70 patients with diffuse large B-cell lymphoma, follicular lymphoma grade IIIB or transformed indolent lymphoma will receive up to 6 cycles of the described combination regimen. Follow up visits are scheduled for up to 3 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johannes Gutenberg University Mainz
• Collaborators: CTI BioPharma; Roche Pharma AG; Servier
• Treatments: Obinutuzumab; Pixantrone

Criteria

Inclusion Criteria:

• Patients aged ≥ 18 years

• Histologically proven diagnosis of diffuse large cell B-cell lymphoma (DLBCL), follicular lymphoma (FL) IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)

• Relapsed disease

• Eastern Cooperative Oncology Group (ECOG) performance Status ≤2, unless tumor associated

• Adequate cardiac reserve: Serum Troponin level must be consistent with no significant acute or chronic myocardial damage and there should be no evidence of symptomatic disease

• No curative option available

• At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration

• Adequate bone marrow (BM) reserve: Platelets of at least 100.000/µl (in case of extensive BM-infiltration 75.000/µl may be acceptable after discussion with the coordinating investigator), absolute neutrophil count of at least 1000/µl. Adequate hepatic and renal function: Alanine aminotransferase <2.5 x upper limit of normal (ULN); Aspartate aminotransferase <2.5 x ULN, total bilirubin <1.5 x ULN

• No active Hepatitis B or C or HIV-infection

• Measured or calculated creatinine clearance >30 mL/min

• Fresh tumor biopsy or archived tissue available

• Ability of patients to understand nature, importance and individual consequences of clinical trial.

• Signed informed consent

• Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (serum or urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment. Reliable contraception comprises systematic contraceptives (oral, implant, injection) or diaphragm / condoms / intrauterine devices (IUP) with spermicide.

• Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment

Exclusion Criteria:

• Lymphoma other than DLBCL, FL IIIB, transformed indolent Non-Hodgkin's lymphoma (NHL)

• Central nervous System (CNS) involvement (brain MRI (Magnetic resonance Imaging) is required only in cases of clinically suspicious involvement)

• Pregnant or breast-feeding women

• Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinaemia)

• Myocardial infarction within the last 6 months

• Active uncontrolled infections including HIV-positivity, active Hepatitis B or C

• Vaccination with live vaccine within last 4 weeks

• Mental status precluding patient's compliance

• Known CD20 negativity

• Diagnosed or treated for a malignancy other than NHL except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ (DCIS) of the breast, or other solid tumors curatively treated with no evidence of disease for >3 years, or prostate cancer with a life expectancy of more than 2 years

• Treatment with any approved anticancer agent within last 2 weeks. Any agents must have been stopped at least 2 weeks prior to day 1 of GOAL treatment and all treatment related adverse events must have returned to Grade 1.

• Prior exposition to Obinutuzumab or Pixantrone

• History of hypersensitivity to medicinal products with similar chemical structure as the trial medication

• Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation. Concurrent participation in non-treatment studies is not excluded

• Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.