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Trial record 1 of 3 for:    betalutin
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Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)

This study is currently recruiting participants.
Verified April 2017 by Nordic Nanovector
Sponsor:
ClinicalTrials.gov Identifier:
NCT02658968
First Posted: January 20, 2016
Last Update Posted: April 10, 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.
Information provided by (Responsible Party):
Nordic Nanovector
  Purpose
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 tolerable dose 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 toxicity, pharmacokinetics, biodistribution and efficacy.

Condition Intervention Phase
Relapsed, Diffuse Large B-cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma Drug: Betalutin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nordic Nanovector:

Primary Outcome Measures:
  • Determine the Maximum Tolerated Dose [ Time Frame: 12 weeks ]
    To determine the maximum tolerated dose of Betalutin that can be given to patients with relapsed/refractory, diffuse large B-cell lymphoma, not eligible for autologous stem cell transplant.


Secondary Outcome Measures:
  • The best overall tumour response rate [ Time Frame: 3 months - 2 years ]
    Efficacy evaluations are measured by tumour response rates using CT and PET/CT imaging with responses classified according to revised response criteria for NHL (Cheson, 2014).

  • Dosimetry [ Time Frame: 3 weeks ]
    Dosimetry will be evaluated by the estimated absorbed radiation dose to target organs.


Estimated Enrollment: 18
Study Start Date: January 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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® (lutetium (177Lu)-lilotomab satetraxetan), single injection with lilotomab pre-dosing.
Other Name: Betalutin, lutetium (177Lu)-lilotomab satetraxetan

  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. Male or female aged ≥18 years.
  2. Histologically confirmed DLBCL (WHO classification).
  3. Received at least one prior line of therapy including immuno-chemotherapy.
  4. In first or subsequent relapse, or refractory to the last treatment (defined as less than a complete metabolic response to the last treatment, or within 6 months from the last treatment).
  5. Not suitable for, or declined high dose chemotherapy and autologous stem cell transplantation (ASCT).
  6. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (at least one objectively bi-dimensionally measurable (nodal) lesion (>2 cm in its largest dimension by CT scan).
  7. Negative human anti-murine antibody (HAMA) test.
  8. Life expectancy of at least 3 months.
  9. Bone marrow tumour infiltration <25% tumour cells.
  10. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  11. Normal organ and bone marrow function defined as:

    1. Absolute neutrophil count ≥1.5 x 109/L;
    2. Platelet count ≥150 x 109/L;
    3. Haemoglobin ≥9 g/dL;
    4. Total bilirubin ≤1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome);
    5. Liver enzymes: Aspartate transaminase (AST); Alanine transaminase (ALT) or Alkaline phosphatase (ALP) ≤2.5 x ULN (or ≤5.0 x ULN if liver involvement by primary disease);
    6. Adequate renal function as demonstrated by a serum creatinine ≤1.5 mg/dL or a creatinine clearance >60 mL/min;
    7. Normal coagulation parameters (elevated international normalized ratio (INR), prothrombin time or activated partial thromboplastin time (APTT) ≤1.3 ULN range acceptable).
  12. Women of childbearing potential must

    1. understand that the study medication may have teratogenic risk
    2. have a negative serum pregnancy test at screening and before Betalutin injection
    3. commit to continued abstinence from heterosexual intercourse (excluding periodic abstinence or the withdrawal method) or begin two acceptable methods of birth control with a Pearl-Index ≤ 1%. without interruption from 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. Apart from abstinence, acceptable methods of birth control are:

      • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
      • oral
      • intravaginal
      • transdermal
      • Progestogen-only hormonal contraception associated with inhibition of ovulation
      • oral
      • injectable
      • implantable
      • Intrauterine device (IUD)
      • Intrauterine hormone-releasing system ( IUS)
      • Bilateral tubal occlusion
      • Vasectomised partner
  13. Male patients must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
  14. Ability to give written, informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
  15. Capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document.
  16. A negative Hepatitis B test (HBsAg and anti-HBc) and negative HIV test during screening

Exclusion Criteria:

  1. Prior hematopoietic allogenic stem cell transplantation.
  2. Prior autologous stem cell transplantation.
  3. Previous total body irradiation, or irradiation of >25% of the patient's bone marrow.
  4. Prior anti-lymphoma therapy (chemotherapy, immunotherapy or other investigational agent) within 4 weeks prior to start of study treatment (corticosteroid treatment at doses of ≤20 mg/day, G-CSF or GM CSF are permitted up to 2 weeks prior to start of study treatment.). Note: excluding pre-treatment with rituximab as part of this study
  5. Patients who are receiving any other investigational agents.
  6. Patients with known or suspected central nervous system involvement of lymphoma.
  7. History of a previous treated cancer except for the following:

    1. adequately treated local basal cell or squamous cell carcinoma of the skin;
    2. cervical carcinoma in situ;
    3. superficial bladder cancer;
    4. localized prostate cancer undergoing surveillance or surgery;
    5. localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy;
    6. other adequately treated Stage 1 or 2 cancer currently in complete remission;
  8. Pregnant or breastfeeding women.
  9. Exposure to another CD37 targeting drug.
  10. Allergy to X ray contrast agents.
  11. A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, HH1 or Betalutin.
  12. Has received a live attenuated vaccine within 30 days prior to enrolling in the study.
  13. Evidence of severe or uncontrolled systemic diseases:

    1. uncontrolled infection including evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment;
    2. pulmonary conditions e.g. unstable or uncompensated respiratory disease
    3. hepatic, renal neurological or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives.
    4. psychiatric conditions e.g. patients unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the study
    5. history of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome;
    6. cardiac conditions, including

      • history of acute coronary syndromes (including unstable angina)
      • class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system;
      • known uncontrolled arrhythmias (except sinus arrhythmia) in the past 24 weeks.
  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): NCT02658968


Contacts
Contact: Laurie Baylor Curtis +44 75950502495 lbaylorcurtis@nordicnanovector.com

Locations
United States, California
Not yet recruiting
San Diego, California, United States, 92093
Not yet recruiting
San Francisco, California, United States, 94117
United States, Florida
Recruiting
Miami, Florida, United States, 33146
Germany
Not yet recruiting
Munich, Germany, 81675
Italy
Recruiting
Bologna, Italy, 40138
Recruiting
Torino, Italy, 10126
Not yet recruiting
Verona, Italy, 37134
Spain
Recruiting
Valencia, Spain, 46026
Not yet recruiting
Zaragoza, Spain, 50012
United Kingdom
Recruiting
Bristol, United Kingdom, BS2 8ED
Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Tim Illidge         
Sponsors and Collaborators
Nordic Nanovector
Investigators
Principal Investigator: Timothy Illidge, PhD MB BS University of Manchester, The Christie NHS Foundation Trust
  More Information

Publications:
Responsible Party: Nordic Nanovector
ClinicalTrials.gov Identifier: NCT02658968     History of Changes
Other Study ID Numbers: EudraCT: 2015-001933-26
First Submitted: December 22, 2015
First Posted: January 20, 2016
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nordic Nanovector:
Betalutin
Radioimmunotherapy
Lu-177
Phase I study
ARC
Antibody Radionuclide Conjugate
HH1
Rituximab
177Lu-DOTA-HH1
Lilotomab
Lutetium (177Lu)-lilotomab satetraxetan
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Diffuse Large B-Cell Lymphoma
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
DLBCL
Refractory DLBCL
Relapsed DLBCL

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


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