Clinical trial · Interventional
GOAL: GA101 Plus Pixantrone for Relapsed Aggressive Lymphoma
The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obinutuzumab and Pixantrone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Obinutuzumab and Pixantrone
- description
- Obinutuzumab: 1000 mg flat dose on day 1, 8, 15 of cycle one and day 1 of subsequent cycles Pixantrone: 50 mg/m² Pixantrone on day 1,8,15 of each 28 d cycle
- interventionNames
- Drug: Obinutuzumab and Pixantrone
Primary outcomes (1)
- measure
- Objective overall response rate (ORR) after six treatment cycles or the individual end of treatment
- timeFrame
- 30 weeks
- description
- The response to treatment is measured by results of computer tomography (CT) for measurable lesions and evaluation for non-measurable lesions after cycle 6 or at the individual end of treatment.
Secondary outcomes (6)
- measure
- Safety of the combination treatment as measured by the rate of adverse events, which reflects tolerability of the treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available