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A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-01)

This study is currently recruiting participants.
Verified September 2017 by Nordic Nanovector
Sponsor:
ClinicalTrials.gov Identifier:
NCT01796171
First Posted: February 21, 2013
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Nordic Nanovector
  Purpose
This study is a phase I/II, open-label study in patients with relapsed positive non-Hodgkin lymphoma. The Phase I part of the study is a dose escalating study to define the maximum tolerable dose of (177Lu)-lilotomab (Betalutin), assess safety and toxicity, pharmacokinetics, biodistribution and efficacy. After completion of the phase I study, a dose will be selected for the phase II part of the study which is designed to investigate tumour response rate, progression free survival, confirmation of the selected dose as well as safety and toxicity.

Condition Intervention Phase
Non-Hodgkin Lymphoma Drug: Betalutin Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of (177Lu)-Lilotomab (Betalutin®) Radioimmunotherapy for Treatment of Relapsed Non-Hodgkin Lymphoma.

Resource links provided by NLM:


Further study details as provided by Nordic Nanovector:

Primary Outcome Measures:
  • Safety/Dose limiting toxicity [ Time Frame: 12 weeks ]

    Patients are closely monitored during and after injection of Betalutin over a 12 week period. Thereafter, at certain intervals up to 5 years. Safety evaluations are vital signs, physical examination, hematology and serum biochemistry.

    Adverse events and abnormal laboratory values will be graded for toxicity according to CTCAE version 4.



Secondary Outcome Measures:
  • Efficacy [ Time Frame: 3 months - 5 years ]
    CT or PET/CT imaging will be used to quantify changes in lesions on baseline imaging, with responses classified according to revised response criteria for NHL (Cheson, 2007.)


Estimated Enrollment: 77
Actual Study Start Date: December 2012
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: With lilotomab pre-dosing
Betalutin, 10 MBq/kg b.w. in escalated doses with lilotomab pre-dosing.
Drug: Betalutin
Dose finding study, starting on 10 MBq/kg b.w. Betalutin ((177Lu)-lilotomab), single injection.
Experimental: Without pre-dosing
Betalutin, 15 MBq/kg b.w. in escalated doses without pre-dosing.
Drug: Betalutin
Dose finding study, starting on 10 MBq/kg b.w. Betalutin ((177Lu)-lilotomab), single injection.
Experimental: With rituximab pre-dosing
Betalutin, 15 MBq/kg b.w. in escalated doses with rituximab pre-dosing.
Drug: Betalutin
Dose finding study, starting on 10 MBq/kg b.w. Betalutin ((177Lu)-lilotomab), single injection.
Experimental: Different lilotomab pre-dosing regimen
Betalutin, 15 MBq/kg b.w. in escalated doses with a different lilotomab pre-dosing regimen.
Drug: Betalutin
Dose finding study, starting on 10 MBq/kg b.w. Betalutin ((177Lu)-lilotomab), single injection.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed (by WHO classification) relapsed incurable non-Hodgkin B-cell lymphoma of following subtypes; follicular grade I-IIIA, marginal zone, small lymphocytic, lymphoplasmacytic, mantle cell.
  2. Age ≥ 18 years
  3. A pre-study WHO performance status of 0-1
  4. Life expectancy should be ≥ 3 months
  5. <25% tumour cells in bone marrow biopsy
  6. Measurable disease by radiological methods
  7. Women of childbearing potential must:

    1. understand that the study medication is expected to have teratogenic risk
    2. have a negative pregnancy test
    3. agree to use, and be able to comply with, effective contraception 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
  8. Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 12 months
  9. Patients previously treated with native rituximab are eligible
  10. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination
  11. The patient has been fully informed about the study and has signed the informed consent form

Exclusion Criteria:

  1. Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, uncontrolled asthma/allergy requiring systemic steroids, known HIV positive
  2. Laboratory values within 15 days pre-registration:

    1. Absolute Neutrophil Counts (ANC) ≤ 1.5 x 109 /l
    2. Platelet count ≤ 150 x 109 /l
    3. Total bilirubin ≥ 30 mmol/l
    4. ALP and ALAT ≥ 4x normal level)
    5. Creatinine ≥ 115 µmol/l (men), 97 µmol/l (women))
  3. Known CNS involvement of lymphoma
  4. Previous total body irradiation
  5. Known history of HAMA
  6. Chemotherapy or immunotherapy received within the last 4 weeks prior to start of study treatment. Pretreatment with rituximab is allowed
  7. Pregnant or lactating women
  8. Previous hematopoietic stem cell transplantation (autologous and allogenic)
  9. Previous treatment with radioimmunotherapy
  10. Actively participating in another study or received an investigational drug within 4 weeks prior to enrolment
  11. Receipt of live, attenuated vaccine within 30 days prior to enrolment
  12. Test positive for hepatitis B (HBsAg and anti-HBc)
  13. A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, HH1 or Betalutin
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796171


Contacts
Contact: Laurie Baylor Curtis +44 (0)7950502495 lbaylorcurtis@nordicnanovector.com

Locations
Austria
Recruiting
Innsbruck, Austria, 6020
Recruiting
Linz, Austria, 4020
Recruiting
Wien, Austria, 1090
Croatia
Not yet recruiting
Zagreb, Croatia
Czechia
Recruiting
Olomouc, Czechia, 779 00
Recruiting
Ostrava-Poruba, Czechia, 708 52
Italy
Recruiting
Bologna, Italy, 40138
Not yet recruiting
Firenze, Italy, 50134
Norway
Recruiting
Bergen, Norway
Recruiting
Oslo, Norway, 0310
Recruiting
Trondheim, Norway, 7006
Poland
Recruiting
Krakow, Poland, 50-510
Not yet recruiting
Warszawa, Poland, 02-097
Sweden
Recruiting
Borås, Sweden, 50455
Recruiting
Linköping, Sweden, 581 85
Recruiting
Umeå, Sweden
United Kingdom
Recruiting
Poole, Dorset, United Kingdom, BH15 2JB
Recruiting
Bristol, United Kingdom, BS2 8ED
Recruiting
Glasgow, United Kingdom, G12 0YN
Recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Nordic Nanovector
ICON Clinical Research
Investigators
Principal Investigator: Arne Kolstad, MD, PhD Oslo University Hospital
  More Information

Publications:
Responsible Party: Nordic Nanovector
ClinicalTrials.gov Identifier: NCT01796171     History of Changes
Other Study ID Numbers: EudraCT: 2011-000033-36
First Submitted: February 19, 2013
First Posted: February 21, 2013
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Nordic Nanovector:
Radioimmunotherapy
Lu-177
Phase I study
Phase II study
Betalutin

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases