NCT02499003

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 14, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3.4 years

First QC Date

July 6, 2015

Last Update Submit

March 30, 2022

Conditions

Lymphoma, Non-Hodgkin

Keywords

Diffuse large B-cell lymphomaFollicular lymphomaTransformed indolent lymphoma

Outcome Measures

Primary Outcomes (1)

  • Objective overall response rate (ORR) after six treatment cycles or the individual end of treatment

    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.

    30 weeks

Secondary Outcomes (6)

  • Safety of the combination treatment as measured by the rate of adverse events, which reflects tolerability of the treatment.

    30 weeks

  • Percentage of patients completing the entire trial treatment

    30 weeks

  • Evaluation of best response to trial treatment as measured as best response either during or post the entire treatment

    30 weeks

  • Progression free survival

    up to 3 years

  • Overall survival

    up to 3 years

  • +1 more secondary outcomes

Study Arms (1)

Obinutuzumab and Pixantrone

EXPERIMENTAL

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

Drug: Obinutuzumab and Pixantrone

Interventions

Obinutuzumab and PixantroneDRUG

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

Also known as: GA101 /Gazyvaro, Pixuvri
Obinutuzumab and Pixantrone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, Oncology and Pneumology; University Medical Center of the Johannes Gutenberg-University

Mainz, RLP, 55131, Germany

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Follicular

Interventions

obinutuzumabpixantrone

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-Cell

Study Officials

  • Georg Hess, MD

    Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Ivestigator

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 15, 2015

Study Start

August 14, 2015

Primary Completion

January 2, 2019

Study Completion

January 2, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

DE(1)