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Trial record 89 of 430 for:    ifosfamide

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 : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

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.

Condition or disease Intervention/treatment Phase
Aggressive Non-Hodgkin Lymphoma Drug: Pixantrone Other: Ifosfamide Other: Etoposide Other: Rituximab Procedure: Transplant Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 89 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : March 2025


Arm Intervention/treatment
Experimental: Experimental
Pixantrone plus rituximab, ifosfamide and etoposide.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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. ]
  5. 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. ]
  6. 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

  7. 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



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

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

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): NCT03458260


Contacts
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Contact: Laetitia Melgar +33472669333 laetitia.melgar@lysarc.org

Locations
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France
CH d'Avignon Recruiting
Avignon, France
Contact: Borhane Slama         
Hôpital Haut-Lévèque Recruiting
Bordeaux, France
Contact: Krimo Bouabdallah         
CHRU de Lille Recruiting
Lille, France
Contact: Franck Morschhauser         
CHU Lyon Sud Recruiting
Lyon, France
Contact: Gilles Salles         
CHU de la Conception Recruiting
Marseille, France
Contact: Vadim Ivanov         
Centre Lacassagne Recruiting
Nice, France
Contact: Antoine Thyss         
Hopital La Pitié Salpétriere Recruiting
Paris, France
Contact: Sylvain Choquet         
Hôpital St louis Recruiting
Paris, France
Contact: Sandy Amorin         
CHU de Poitiers Recruiting
Poitiers, France
Contact: Vincent Delwail         
CH de Cornouaille Recruiting
Quimper, France
Contact: Ronan Le Calloch         
CHU de Rouen Recruiting
Rouen, France
Contact: Hervé Tilly         
CHU de Strasbourg Recruiting
Strasbourg, France
Contact: Luc-Matthieu Fornecker         
CHU de Tours Recruiting
Tours, France
Contact: Emmanuel Gyan         
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Investigators
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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

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Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT03458260     History of Changes
Other Study ID Numbers: PIVeR
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by The Lymphoma Academic Research Organisation:
Diffuse Large B-Cell Lymphoma (DLBCL)
relapsed or refractory

Additional relevant MeSH terms:
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Ifosfamide
Isophosphamide mustard
Lymphoma
Lymphoma, Non-Hodgkin
Aggression
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Rituximab
Etoposide
Etoposide phosphate
Pixantrone
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents