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Trial record 1 of 1 for:    NCT03458260
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Study of Pixantrone in CD20+ Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT03458260
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

Tracking Information
First Submitted Date  ICMJE February 26, 2018
First Posted Date  ICMJE March 8, 2018
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE March 26, 2018
Actual Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
Overall Metabolic Response rate (OMR) according to local investigator [ Time Frame: After 42 days of treatment (2 cycles) or at permanent treatment discontinuation. ]
by local investigator according to Lugano classification 2014
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03458260 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
  • Complete Metabolic Response rate (CMR) according to local investigator [ Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation. ]
    according to local investigator
  • Overall Metabolic Response rate (OMR) according to central review [ Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation. ]
    according to local investigator
  • Complete Metabolic Response rate (CMR) according to central review [ Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation. ]
    according to local investigator
  • Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: After 42 or 126 days of treatment (2 or 6 cycles of 21 days) or at permanent treatment discontinuation. ]
  • Number of patients for whom Partial Metabolic Response (PMR) is transformed into CMR [ Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation. ]
  • Rate of ASCT [ Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation. ]
    Number of patients who perform an ASCT out of total number of patients
  • Success of stem cell collection after treatment [ Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation. ]
    Rate of successful stem cell collection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pixantrone in CD20+ Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma
Official Title  ICMJE A Multicentre, Phase II, Open Label, Single Arm Study of Pixantrone in Patients With CD20-positive Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma Treated With Rituximab, Ifosfamide and Etoposide.
Brief Summary This study will evaluate the efficacy of Pixantrone with rituximab, ifosfamide and etoposide as measured by the overall metabolic response rate after 2 cycles of treatment or at permanent treatment discontinuation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aggressive Non-Hodgkin Lymphoma
Intervention  ICMJE
  • Drug: Pixantrone
    6 cycles - dose = 80mg/m²
    Other Name: Pixuvri
  • Other: Ifosfamide
    6 cycles - 1500 mg/m2
    Other Name: Holoxan
  • Other: Etoposide
    6 cycles - 150 mg/m2
    Other Name: Vepeside
  • Other: Rituximab
    6 cycles - 375 mg/m2
    Other Name: Mabthera
  • Procedure: Transplant
    after 2 or 6 cycles
Study Arms  ICMJE Experimental: Experimental
Pixantrone plus rituximab, ifosfamide and etoposide.
Interventions:
  • Drug: Pixantrone
  • Other: Ifosfamide
  • Other: Etoposide
  • Other: Rituximab
  • Procedure: Transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2018)
89
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2025
Actual Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically proven CD20+ aggressive non-Hodgkin lymphoma (diffuse large B-cell lymphoma (DLBCL), de novo or transformed DLBCL from previously untreated low grade non-Hodgkin lymphoma or grade 3b follicular lymphoma) as per the World Health Organization (WHO) 2016 criteria
  2. Relapsed or refractory disease, defined as follows:

    1. Patients eligible for ASCT who failed to achieve a Complete Response (CR) after at least one salvage therapy (eg, Rituximab-Etoposide- Methylprednisolone - Cytarabine - Cisplatin (R-ESHAP) or Rituximab- Dexamethasone- High-dose Cytarabine - Cisplatin (R-DHAP), patients who were previously refractory to Rituximab-Ifosfamide-Cytarabine-Etoposide (R-ICE) (stable disease or progressive disease) are not eligible to the study)
    2. Or patients in first relapse after Autologous Stem Cell Transplant (ASCT)
    3. Or patients not eligible for ASCT who failed to achieve a CR after at least one prior treatment (and no more than 4 previous lines) or in relapse after at least one prior treatment (and no more than 4 previous lines).
  3. Age > or =18 years
  4. Eastern Cooperative Oncology Group (ECOG) performance status < or = 2
  5. Subjects must have evaluable disease based on positron emission tomography (PET-CT) scan
  6. Minimum life expectancy of 6 months
  7. Signed written informed consent
  8. Patient covered by any social security system
  9. Men must agree to use a barrier method of contraception during the treatment period and until 6 months after the last dose of chemotherapy
  10. Women of childbearing potential must agree to use an adequate method of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception during the treatment period and until 12 months after the last dose of chemotherapy

Exclusion Criteria:

  1. Any other histological type of lymphoma (Burkitt lymphoma, mantle-cell lymphoma…)
  2. Any history of previously treated indolent non-Hodgkin lymphoma
  3. Symptomatic central nervous system or meningeal involvement by the lymphoma
  4. Contraindication to any drug contained in the Pixantrone with rituximab, ifosfamide and etoposide regimen
  5. Treatment with any investigational drug within 28 days before the first study drug administration
  6. Any of the following lab abnormalities unless related to the lymphoma or bone marrow infiltration:

    1. Absolute neutrophil count (ANC) < 1.0 G/L
    2. Platelet count < 100 G/L
    3. Creatinine clearance < 40 mL/min for patients < 70 y, or creatinine clearance < 60 mL/min for patients > or = 70 y, by Modification of Diet in Renal Disease (MDRD) method.
    4. Total bilirubin level > 1,5 x Upper Limit of Normal (ULN)
    5. Serum ASpartate Transaminase (AST) or ALanine Transaminase (ALT)> 2,5x ULN
  7. Known Human Immunodeficiency Virus (HIV) positive
  8. Active hepatitis C virus (HCV) (Positive HCV serology with positive Polymerase Chain Reaction (PCR) for HCV RNA)
  9. Active hepatitis B (HB) :

    1. HBsAg positive
    2. HBsAg negative, Ac anti-HBs positive and/or Ac anti-HB core (HBc) positive (Patients who are seropositive due to a history of hepatitis B vaccine are eligible. Patients with Ac anti-HBs positive and/or Ac anti-HBc positive and no history of hepatitis B vaccine are eligible only if PCR for HB virus DNA is negative)
  10. Cumulative dose of doxorubicine or equivalent > 450mg/m2
  11. Left ventricular ejection fraction (LVEF) < 50% measured by echocardiography or isotopic method
  12. Congestive heart failure (any stage from New York Heart Association (NYHA) classification)
  13. Uncontrolled arterial hypertension
  14. Severe rhythmic heart disease
  15. Uncontrolled ischemic heart disease, including patients with stable angina
  16. Significant valvular heart disease
  17. History of a myocardial infarction within 6 months prior to enrolment
  18. Pregnant or lactating females
  19. Prior history of malignancies with the exception of non-melanoma skin tumors (basal cell or squamous cell carcinoma) or in situ cervical carcinoma
  20. Any serious active disease or co-morbid medical condition according to the investigator's decision
  21. Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
  22. Use of any standard or experimental anti-cancer drug therapy within 28 days before the first study drug administration
  23. Use of corticosteroids prior to baseline PET-CT
  24. Person deprived of his/her liberty by a judicial or administrative decision
  25. Person hospitalized without consent
  26. Adult person under legal protection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laetitia Melgar +33472669333 laetitia.melgar@lysarc.org
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03458260
Other Study ID Numbers  ICMJE PIVeR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Lymphoma Academic Research Organisation
Study Sponsor  ICMJE The Lymphoma Academic Research Organisation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luc-Matthieu Fornecker CHU de Strasbourg
Principal Investigator: Eric Van den Neste UCL St Luc Bruxelles
Principal Investigator: Sandy Amorin Hôpital St Louis - Paris
PRS Account The Lymphoma Academic Research Organisation
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP