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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02657447
• Date of registration: 22/12/2015
• Prospective Registration: Yes
• Primary sponsor: Nordic Nanovector
• Public title: Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02)
• Scientific title: 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
• Date of first enrolment: December 19, 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02657447
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Andreas Buck, Prof. MD
• Affiliation: Wuerzburg University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Histologically confirmed (by WHO classification) relapsed indolent non-Hodgkin B-cell
lymphoma of following subtypes: Follicular lymphoma (follicular grade I-IIIA),
Marginal zone lymphoma (exclusion of MZL if large lymphocytes > 50%), Small
lymphocytic lymphoma, Lymphoplasmacytoid and classical mantle cell lymphoma (no
blastoid MCL).

2. Requiring initiation of treatment for the NHL.

3. Relapsed after at least one line of therapy including rituximab combination
chemotherapy regimen.

4. Exhausted and/or ineligible for all standard treatment options.

5. Not a candidate for an autologous or allogeneic stem cell transplantation. Patients in
progression after successful stem cell collection before before high-dose therapy and
autologous stem cell transplantation may be considered for enrolment.

6. Age = 18 years..

7. A pre-study ECOG performance status of 0-2. In selected patients an ECOG score of 3
can be acceptable if it is clearly lymphoma-associated at the discretion of the
investigator.

8. Life expectancy should be = 3 months.

9. 9. < 25% tumour cells in bone marrow biopsy prior to lilotomab/Betalutin treatment
(biopsy taken from a site not previously irradiated).

10. All patients must have at least one bi-dimensionally measurable lesion (>1.5 cm in its
largest dimension by CT scan). Patients without such a target lesion can be accepted
on an individual basis if histological organ involvement can be evaluated for response
e.g. involvement of the skin or the gastrointestinal tract.

11. Women of childbearing potential must:

- have a negative serum pregnancy test at screening and before Betalutin injection

- understand that the study medication is expected to have teratogenic risk

- agree to use, and be able to comply with, highly effective method of birth
control with a Pearl-Index = 1%. Contraception is required without interruption,
4 weeks before starting study drug, throughout study drug therapy and for 12
months after end of study drug therapy, even if she has amenorrhoea.

12. Male subjects must agree to use condoms during intercourse throughout study drug
therapy and the following 12 months.

13. Patients previously treated with native rituximab are eligible.

14. The patient is willing and able to comply with the protocol, and agrees to return to
the hospital for follow-up visits and examination.

15. The patient has been fully informed about the study and has signed the informed
consent form.

16. Negative HAMA test.

17. CD37 positive, re-biopsy or test on existing tumour material if not known

Exclusion Criteria:

1. Medical contraindications, including uncontrolled infection, severe cardiac,
pulmonary, neurologic, psychiatric or metabolic disease, steroid requiring
asthma/allergy, known HIV positive.

2. Laboratory values during screening :

- Absolute Neutrophil Counts (ANC) = 1.5 x 109 /l

- Platelet count = 150 x 109 /l

- Total bilirubin = 30 mmol/l

- ALP and ALAT = 4x normal level

- GFR < 60 ml/min/1.73 m2 as measured by the CKD-EPI method.

3. Known or suspected CNS involvement of lymphoma

4. Previous total body irradiation, or irradiation of > 25% of the patient's bone marrow.

5. Chemotherapy, immunotherapy or another investigational drug received within the last 4
weeks prior to the patient entering screening.

6. Earlier treatment with radioimmunotherapy.

7. Exposure to another CD37 targeting drug.

8. Concurrent participation in another therapeutic treatment trial.

9. Previous hematopoietic stem cell transplantation (autologous and allogenic).

10. Pregnant or lactating women.

11. Transformed or potentially transformed NHL from indolent to aggressive

12. Receipt of live, attenuated vaccine within 30 days prior to enrolment

13. Test positive for hepatitis B (HBsAg and anti-HBc)

14. A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any
excipient used in rituximab, HH1 or Betalutin

15. Malignant disease, other than that being treated in this study. Exceptions include:
malignancies that were treated curatively and have not recurred within 3 years prior
to study entry; completely resected basal cell and squamous cell skin cancers;
completely resected carcinoma in situ of any type.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Hodgkin Lymphoma

Intervention(s)

Drug: Betalutin with lilotomab dose 1

Drug: Betalutin with lilotomab dose 2

Primary Outcome(s)

Dosimetry [Time Frame: 3 weeks]

Secondary Outcome(s)

Lilotomab pharmacokinetics [Time Frame: 3 weeks]

The number of participants with adverse events as assessed by NCTCAE. [Time Frame: 12 weeks]

Efficacy (Best overall response rate) [Time Frame: 3 months - 1 year]

Secondary ID(s)

EudraCT: 2013-003908-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors