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Lymphoma, Non-Hodgkin

Lymphoma, Large B-Cell, Diffuse

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Lymphoma, B-Cell

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B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

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Antibodies

Rituximab

Immunoglobulins

10 MBq/kg b.w., in escalated doses with lilotomab pre-dosing

Dose finding study, starting on 10 MBq/kg b.w. Betalutin® (lutetium (177Lu)-lilotomab satetraxetan), single injection with lilotomab pre-dosing.

Betalutin

Timothy Illidge, PhD MB BS

This study is a phase 1, dose finding, open-label study in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This is a dose escalating study to define the maximum tolerated dose (MTD) of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) in DLBCL patients who are not eligible for autologous stem cell transplant. The study will also assess safety and tolerability, pharmacokinetics, biodistribution and efficacy.

Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)

A Phase 1 Dose Finding Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) in Patients With Relapsed/Refractory, Diffuse Large B-cell Lymphoma, Not Eligible for Autologous Stem Cell Transplant

To determine the MTD of Betalutin that can be administered to DBLCL patients with lilotomab. The MTD was the highest dose at which less than two out of six participants experienced a dose limiting toxicity (DLT) defined as:

* Haematologic toxicity:

  * Grade 4 neutropenia observed for greater than 7 days' duration
  * Grade 4 thrombocytopenia observed for greater than 7 days' duration
  * Grade 3 or 4 neutropenia associated with fever (≥38.5°C) of any duration
  * Grade 3 or 4 thrombocytopenia with bleeding
  * Thrombocytopenia with any requirement for more than one platelet transfusion before recovering to Grade 1 or less
  * Grade 4 anaemia, unexplained by underlying disease
* Non-haematologic toxicity:

  * Grade 3 nausea/vomiting/diarrhoea lasting longer than 72 hours despite maximal care or Grade 4
  * Any other Grade 3 or 4 non-haematologic toxicities
  * Any Grade 3 or 4 electrolyte abnormalities that do not resolve to Grade 1 or baseline within 24 hours

Efficacy evaluations are measured by tumour response rates using CT and PET/CT imaging with responses classified as described in "Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification" (Cheson, 2014). The Cheson criteria, 2014 are a combined score taking into consideration, positive or negative scored PET scan, the contrast enhanced CT images and bone marrow biopsies when available.

Dosimetry will be evaluated by the estimated absorbed radiation dose to target organs.

Nordic Nanovector

Treatment emergent adverse events were summarized separately after rituximab and after Betalutin/lilotomab

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 .

60/10

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2.

100/10

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 .

100/15

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0.

100/20

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing on Day 0 following rituximab pre-treatment on Day -14.

Received rituximab pre-treatment on Day -14. Did not receive Betalutin or lilotomab

Rituximab Only

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

0-5 scale (5 the worst outcome) 0 Fully active, able to carry on all pre-disease performance without restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work
2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5. Dead

ECOG score

Eligible participants who received rituximab

Head of Clinical Operations

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing.

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.

Number of Participants With DLTs to Determine the MTD

Participants who had a baseline and at least one post-baseline computed tomography scan

The Best Overall Tumour Response

Liver

Spleen

Kidneys

Image-based Red Marrow

Total Body

Participants having dosimetry evaluation and having the schedule of whole body imaging or SPECT/CT scans

Dosimetry

Received Rituximab

Received Lilotomab and Betalutin

Symptoms and General Pathology

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Chelating Agents

Betalutin 15 MBq/kg b.w. with lilotomab pre-dosing

Betalutin 15MBq/kg b.w. with lilotomab pre-dosing

15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 1

Betalutin with lilotomab dose 1

15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 2

Betalutin with lilotomab dose 2

Andreas Buck, Prof. MD

This study is a phase I, open label, randomized study to assess pharmacokinetics, biodistribution and radiation dosimetry of lutetium (177Lu) lilotomab satetraxetan (Betalutin®) radioimmunotherapy in patients with relapsed non-Hodgkin lymphoma. The study will also investigate the safety, toxicity and efficacy of Betalutin and pre-dosing.

Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02)

A Phase 1, Open Label, Randomized Study to Assess Pharmacokinetics, Biodistribution and Radiation Dosimetry of Lutetium (177Lu) Lilotomab Satetraxetan (Betalutin®) Radioimmunotherapy in Patients With Relapsed Non-Hodgkin Lymphoma

Estimation of individual tumour/organ uptake and retention of radioactivity.

Best overall response rate by treatment group as measured by Cheson Criteria.

Estimation using decay correction measurements

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)	NCT02658968	Relapsed, Diffu... Refractory Diff...	Betalutin	18 Years -	Nordic Nanovector
Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)	NCT02658968	Relapsed, Diffu... Refractory Diff...	Betalutin	18 Years -	Nordic Nanovector
Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02)	NCT02657447	Non-Hodgkin Lym...	Betalutin with ... Betalutin with ...	18 Years -	Nordic Nanovector
Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)	NCT02658968	Relapsed, Diffu... Refractory Diff...	Betalutin	18 Years -	Nordic Nanovector

Spots Global Cancer Trial Database for betalutin

Every month we try and update this database with for betalutin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for betalutin

Every month we try and update this database with for betalutin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for betalutin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.