A Phase 1/2 Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma

Completed · Phase 1/Phase 2

Conditions studied: Non-Hodgkin Lymphoma, Follicular Lymphoma

In brief

This study is a Phase 1/2 open-label three part study in patients with relapsed indolent Non-Hodgkin's lymohoma (NHL) (Parts A and C) or relapsed/refractory follicular lymphoma (FL) (Part B).

Key facts

Study ID

NCT01796171

Run by

Nordic Nanovector

People needed

191

Starts

2012-12-01

Expected to finish

2022-10-27

Last updated by the study team

2024-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed (by World Health Organization [WHO] classification) relapsed incurable non-Hodgkin B-cell lymphoma of following subtypes; follicular grade I-IIIA (for Part C, this excludes patients meeting Part B criteria, who should enter Part B), marginal zone, small lymphocytic, lymphoplasmacytic, mantle cell.
• Age ≥ 18 years.
• Part A: A pre-study WHO performance status of 0-1; Part C: WHO performance status of 0-2.
• Life expectancy should be ≥3 months.
• <25% tumour cells in bone marrow biopsy (biopsy taken from a site not previously irradiated).
• Measurable disease by radiological methods.
• Women of childbearing potential must:
• understand that the study medication is expected to have teratogenic risk.
• have a negative pregnancy test.
• agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study medication, throughout study medication therapy and for 12 months after end of study medication therapy, even if she has amenorrhoea.
• Male patients must agree to use condoms during intercourse throughout study medication therapy and the following 12 months.
• Patients previously treated with native rituximab are eligible.
• The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow up visits and examination.
• The patient has been fully informed about the study and has signed the informed consent form.

You may not qualify if…

• Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, uncontrolled asthma/allergy requiring systemic steroids, known to be human immunodeficiency virus (HIV) positive.
• Laboratory values within 15 days pre-registration:
• Absolute neutrophil counts (ANC) ≤1.5×109/L.
• Part A: Platelet count ≤150×109/L; Part C: Platelet count <150×109/L. For Part C, criteria 2a and 2b must be satisfied within 72 hours of the administration of rituximab
• Total bilirubin ≥30 mmol/L (Part A only). Total bilirubin > 1.5×ULN (except patients with documented Gilbert's syndrome [≥3.0 mg/dL]) (Part C only).
• Alkaline phosphatase (ALP) and alanine transaminase (ALT) ≥4×normal level (Part A only).
• Aspartate transaminase (AST), ALT or ALP >2.5×ULN (or >5.0×ULN with liver involvement by primary disease). (Part C only).
• Creatinine ≥115 µmol/L (men), 97 µmol/L (women) (Part A only). Serum creatinine ≥1.5×ULN (Part C only).
• Haemoglobin <9.0 g/dL (Part C only). 3. Known central nervous system (CNS) involvement of lymphoma. 4. Previous total body irradiation. 5. Positive test for human anti-murine antibody (HAMA) at screening. 6. Chemotherapy or immunotherapy received within the last 4 weeks prior to start of study treatment. Pre treatment with rituximab is allowed.
• Pregnant or lactating women. 8. Previous hematopoietic stem cell transplantation (autologous and allogenic). 9. Part A: Previous treatment with radioimmunotherapy. Part C: Not applicable. 10. Actively participating in another study or received an IMP within 4 weeks prior to enrolment.
• Receipt of live-attenuated vaccine within 30 days prior to enrolment. 12. Part A and Part C: Test positive for hepatitis B (HBsAg and anti-HBc). Part C only: Test positive for hepatitis C and human immunodeficiency virus (HIV).
• A known hypersensitivity to rituximab, lilotomab, Betalutin or murine proteins or any excipient used in rituximab, lilotomab, or Betalutin.
• Part B:
• Inclusion Criteria:
• Histologically confirmed (by WHO classification) relapsed non-Hodgkin B-cell FL (grade I IIIA).
• Male or female aged ≥18 years. 3. Received at least 2 prior systemic anti-neoplastic or immunotherapy-based regimens (maintenance therapy following a CR/PR is not considered to be a separate line of therapy). Systemic regimens including agents such as idelalisib or other PI3K inhibitors qualify as a prior line of therapy.
• Prior therapy must have included a rituximab/anti-CD20 agent and an alkylating agent - which may be been administered in separate regimens.
• Patients must be refractory to any at least one previous regimen that contained rituximab or an anti CD20 agent, with refractoriness defined as:
• i. no response (no CR or PR) during therapy, or ii. a response (CR/PR) lasting less than 6 months after the completion of a regimen including rituximab/anti-CD20 therapy (including occurrence of progressive disease (PD) during rituximab/anti-CD20 maintenance therapy, or within 6 months of completion of maintenance therapy).
• WHO performance status of 0-2. 7. Life expectancy of ≥3 months. 8. Bone marrow tumour infiltration <25% (in biopsy taken from a site not previously irradiated).
• Measurable disease by CT or MRI: longest diameter (LDi) >1.5 cm for nodal lesion, LDi >1.0 cm for extra nodal lesion on an assessment performed during the screening period.
• Criteria 10 and 11 must be satisfied within 72 hours of the administration of rituximab:
• ANC ≥1.5×109/L. 11. Platelet count ≥100×109/L.
• Criteria 12 to 15 must be verified at time of eligibility review within 2 weeks prior to rituximab administration:
• Haemoglobin ≥9.0 g/dL. 13. Total bilirubin ≤1.5×upper limit of normal (ULN) (except patients with documented Gilbert's syndrome [<3.0 mg/dL]).

Where it is running

• Pacific Shores Medical Group — Long Beach, California, United States
• University of California, San Francisco (UCSF) — San Francisco, California, United States
• Boca Raton Regional Hospital — Boca Raton, Florida, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• West Penn Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Dallas, Texas, United States
• Royal Hobart Hospital — Hobart, Australia
• Medizinische Universitaet Innsbruck — Innsbruck, Austria
• Medizinische Universität Wien - AKH Wien, Universitaetsklinik fuer Innere Medizin I — Vienna, Austria
• Universitair Ziekenhuis Gent (UZ Gent) — Ghent, Belgium
• CH Jolimont — La Louvière, Belgium
• UZ Leuven — Leuven, Belgium
• London Health Sciences Centre — London, Canada
• Sault Area Hospital — Sault Ste. Marie, Canada
• Princes Margaret Cancer Centre — Toronto, Canada
• Clinical Hospital Centre Zagreb — Zagreb, Croatia
• University Hospital Olomouc — Olomouc, Czechia
• University Of Arkansas For Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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