Trial record 1 of 1 for:    nordic nanovector
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Nordic Nanovector
Sponsor:
Information provided by (Responsible Party):
Nordic Nanovector
ClinicalTrials.gov Identifier:
NCT01796171
First received: February 19, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

This study is a phase I/II, open-label study in patients with relapsed CD37 positive non-Hodgkin lymphoma. The Phase I part of the study is a dose escalating study to define the maximum tolerable dose of 177Lu-DOTA-HH1 (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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of 177Lu-HH1 (Betalutin)Radioimmunotherapy for Treatment of Relapsed CD37+ 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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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: 36
Study Start Date: December 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Betalutin
Betalutin, 10 MBq/kg b.w., in escalated doses.
Drug: Betalutin
Dose finding study, starting on 10 MBq/kg b.w. Betalutin (177Lu-Dota-tetulomab), single injection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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. CD37+, re-biopsy or test on existing tumour material if not known.
  7. Measurable disease by radiological methods
  8. 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 5 months after end of study drug therapy, even if she has amenorrhoea
  9. Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 5months
  10. Patients previously treated with native rituximab are eligible
  11. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination
  12. 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, steroid requiring asthma/allergy, 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 ≥ 110 µmol/l (men), 90 µmol/l (women))
    6. IgG ≤ 3 gr/l
  3. Known CNS involvement of lymphoma
  4. Previous total body irradiation, or irradiation of > 25% of the patient's bone marrow
  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796171

Contacts
Contact: Bjørg Bolstad +47 22 58 00 04 bb@nordicnanovector.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0310
Contact: Arne Kolstad, MD    +47 22934000    ARNEK@ous-hf.no   
Principal Investigator: Arne Kolstad, MD, PhD         
Sweden
Norrlands University Hospital Not yet recruiting
Umeå, Sweden
Contact: Martin Erlanson, MD         
Sponsors and Collaborators
Nordic Nanovector
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
Study First Received: February 19, 2013
Last Updated: February 19, 2013
Health Authority: Norway: Norwegian Medicines Agency
Norway: Regional Ethics Commitee
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014