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New treatment option for B-cell Non Hodgkin Lymphoma
Official title A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT05991388
What this study is testing
What is Odronextamab?
Odronextamab is an investigational medicine, being studied as a potential treatment for b-cell non hodgkin lymphoma.
Also referred to as REGN-1979.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The Glo-BNHL trial is trying to find better medicines for children and young people with B-cell non-Hodgkin Lymphoma (B-NHL) that does not go away (refractory B-NHL) or does but comes back again (relapsed B-NHL). B-NHL is a type of cancer that develops inside or outside of lymph nodes (glands) and organs such as the liver or spleen.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 25
You may be able to join if
- applicable to all treatment arms:
- Histologically proven mature B-NHL (Diffuse Large B-Cell Lymphoma (DLBCL), Burkitt Lymphoma/Leukaemia or atypical Burkitt/Burkitt-like lymphoma...
- Radiologically and/or histologically proven B-NHL in first relapse (only one prior line of therapy) or subsequent relapse (more than one prior line...
- If relapse occurs more than two years after previous therapy, a biopsy must be performed
- Evaluable disease as per the international paediatric non-Hodgkin Lymphoma response criteria, including:
You likely can't join if
- B-cell Acute Lymphoblastic Leukaemia (B-ALL)/B-cell Lymphoblastic Lymphoma (B-LBL)
- Patients within:
- 90 days after an allogenic HSCT procedure
- 45 days after an autologous HSCT procedure
- 28 days of experiencing graft versus host disease (GvHD) requiring systemic therapy, and/or immunosuppressive treatment
- 14 days of previous investigational treatment
See the full eligibility criteria
Who can join
- applicable to all treatment arms:
- Histologically proven mature B-NHL (Diffuse Large B-Cell Lymphoma (DLBCL), Burkitt Lymphoma/Leukaemia or atypical Burkitt/Burkitt-like lymphoma, primary mediastinal large B-cell lymphoma (PMLBL), and mature B-NHL/Not...
- Radiologically and/or histologically proven B-NHL in first relapse (only one prior line of therapy) or subsequent relapse (more than one prior line of therapy) or refractory(\ ) B-NHL. (Note: relapses following prior...
- If relapse occurs more than two years after previous therapy, a biopsy must be performed
- Evaluable disease as per the international paediatric non-Hodgkin Lymphoma response criteria, including:
- at least one bi-dimensionally measurable nodal lesion \>1.5 cm in its longest dimension;
- or at least one bi-dimensionally measurable extra-nodal lesion \>1.0 cm in its longest dimension on computerised tomography (CT) or Magnetic Resonance Imaging (MRI);
- or bone marrow involvement (≥25% involvement from bone marrow, if only site of disease. Any standard method of assessment is acceptable i.e. cytomorphology, flow cytometry and/or immunohistochemistry);
- or, dependent on treatment arm, evaluable Central Nervous System (CNS) only disease (evaluable by imaging or Cerebrospinal Fluid (CSF) analysis)(\ \ )
- Age from birth to ≤25 years old at the time of trial entry
- Performance status ≥50 using Karnofsky or Lansky performance scores
- Life expectancy of ≥8 weeks
- Adequate bone marrow function documented by:
- Platelet count ≥50x 10\^9/L (no platelet transfusion therapy within seven days prior to treatment) unless bone marrow involvement(\ \ \ )
- Absolute neutrophil count (ANC) ≥0.75 x 10\^9/L (no granulocyte colony stimulating factor within 2 days prior to treatment) unless bone marrow involvement(\ \ \ )
- Adequate hepatic function documented by:
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤5 x upper limit of normal (ULN)
- Total bilirubin ≤1.5 X ULN \ \ \ Patients with known Gilbert syndrome will be excluded if the total bilirubin value is \>4 x ULN for the local general population
- Documented negative pregnancy test for female patients of childbearing potential within seven days prior to trial entry
- Patients of reproductive potential agrees to use effective contraception whilst on trial treatment and for 12 months following treatment discontinuation
- Written informed consent given by patient and/or parents/legal representative applicable to treatment arm I only:
- Male patients of reproductive potential must agree not to donate sperm whilst on trial treatment and for 6 months following treatment discontinuation
- Adequate renal function, creatinine clearance \>45 ml/min by measurement or estimation (if creatinine levels are normal for the patient's age, using the Cockroft-Gault Equation is sufficient)
- For patients with bone marrow involvement(\ \ \ ) or splenic sequestration, adequate bone marrow function documented by:
- Platelet count ≥25 x 10\^9/L (no platelet transfusion therapy within three days prior to treatment)
- Haemoglobin level ≥7 g/dL
- Absolute neutrophil count (ANC) ≥0.5 x 10\^9/L (no granulocyte colony stimulating factor within two days prior to treatment)
- Patients who have received CAR T-cell therapy or other cellular therapies more than 28 days prior must demonstrate recovery from acute toxicities and have measurable disease applicable to treatment arm II only:
- Adequate renal function, by measured glomerular filtration rate (GFR) \>60 ml/min/1.73m\^2 (estimated GFR is not sufficient)
- For patients with bone marrow involvement(\ \ \ ) or splenic sequestration, requirements for bone marrow function do not apply (\ ) Refractory disease The following patients are considered to have refractory disease and...
- Patients with who do not achieve PR or CR with last therapy
- Patients with partial response to last therapy (biopsy proven), with no evidence of progression (\ \ ) CNS only disease Patients with CNS only disease may be eligible depending on the treatment arm. Please refer to the...
What rules you out
- B-cell Acute Lymphoblastic Leukaemia (B-ALL)/B-cell Lymphoblastic Lymphoma (B-LBL)
- Patients within:
- 90 days after an allogenic HSCT procedure
- 45 days after an autologous HSCT procedure
- 28 days of experiencing graft versus host disease (GvHD) requiring systemic therapy, and/or immunosuppressive treatment
- 14 days of previous investigational treatment
- 28 days of receiving craniospinal radiation; or 14 days of any other radiation
- For patients who have received any CAR T-cell therapy or other cellular therapies, see treatment arm specific eligibility criteria
- Patients who have ongoing acute toxicities from most recent lymphoma directed therapy
- Patients with known DNA repair disorder or known primary immunodeficiency
- Patients who are pregnant or breastfeeding (exclusively or partially)
- Patients who cannot regularly be followed up in accordance with the protocol due to psychological, social, geographical or other issues
- Patients for whom non-compliance with treatment or trial procedures is expected
- Uncontrolled concomitant infection. Severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of trial entry
- Known HIV positivity
- Hepatitis B carrier status, history of Hepatitis B Virus or positive serology. A patient is considered as a Hepatitis B Virus carrier or to have (had) Hepatitis B Virus infection in case of:
- Unimmunized and HBsAg and/or anti-HBs antibody and/or anti- HBc antibody positive,
- Immunized and HBsAg and/or anti-HBc antibody positive.
- Live vaccine within 28 days prior to trial entry
- Known history of hypersensitivity to any of the treatments or excipients Exclusion criteria applicable to treatment arm I only:
- Central Nervous System (CNS) only disease
- Patients within 28 days of any CAR-T cell therapy or other cellular therapies
- Left ventricular shortening fraction (LVSF) \<27% or left ventricular ejection fraction (LVEF) \<50%, as determined by ECHO or MUGA, any evidence of pericardial effusion (except trace or physiological) as determined by...
- Known CD20 negative disease at initial diagnosis
- Seizure within the last 12 months
- Prior treatment with CD20 x CD3 bispecific therapy
- Known hypersensitivity to both allopurinol and rasburicase Exclusion criteria applicable to treatment arm II only:
- Patients within 42 days of any CAR-T cell therapy or other cellular therapies
- Clinically significant (Grade ≥2) third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
- Steroid treatment for more than a total of seven days in the 14 days prior to trial entry
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Perth, Washington, Australia
- Vienna, Austria
- Leuven, Belgium
- Utrecht, Netherlands
- Auckland, New Zealand
- Gothenburg, Sweden
- Birmingham, United Kingdom
- Bristol, United Kingdom
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Brisbane, Queensland, Australia; Perth, Washington, Australia; Vienna, Austria; Leuven, Belgium; Utrecht, Netherlands and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.