Study of Pixantrone in CD20+ Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma
NCT ID: NCT03458260
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
74 participants
INTERVENTIONAL
2018-03-26
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
Pixantrone plus rituximab, ifosfamide and etoposide.
Pixantrone
6 cycles - dose = 80mg/m²
Ifosfamide
6 cycles - 1500 mg/m2
Etoposide
6 cycles - 150 mg/m2
Rituximab
6 cycles - 375 mg/m2
Transplant
after 2 or 6 cycles
Interventions
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Pixantrone
6 cycles - dose = 80mg/m²
Ifosfamide
6 cycles - 1500 mg/m2
Etoposide
6 cycles - 150 mg/m2
Rituximab
6 cycles - 375 mg/m2
Transplant
after 2 or 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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
18 Years
ALL
No
Sponsors
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The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Luc-Matthieu Fornecker
Role: PRINCIPAL_INVESTIGATOR
CHU de Strasbourg
Eric Van den Neste
Role: PRINCIPAL_INVESTIGATOR
UCL St Luc Bruxelles
Sandy Amorin
Role: PRINCIPAL_INVESTIGATOR
Hôpital St Louis - Paris
Locations
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AZ Sint Jan
Bruges, , Belgium
Institut Jules Bordet - Centre des tumeurs de l'ULB
Brussels, , Belgium
Centre Hospitalier de Jolimont
Haine-Saint-Paul, , Belgium
CH d'Avignon
Avignon, , France
Centre Hospitalier de la Côte Basque
Bayonne, , France
CHU Jean Minjoz
Besançon, , France
Hôpital Haut-Lévèque
Bordeaux, , France
Centre Hospitalier William Morey
Chalon-sur-Saône, , France
Clinique Victor Hugo
Le Mans, , France
CHRU de Lille
Lille, , France
CHU Lyon Sud
Lyon, , France
CHU de la Conception
Marseille, , France
Centre Lacassagne
Nice, , France
Hopital La Pitié Salpétriere
Paris, , France
Hôpital St louis
Paris, , France
CHU de Poitiers
Poitiers, , France
Centre Hospitalier Annecy Genevois
Pringy, , France
CH de Cornouaille
Quimper, , France
Hôpital Robert Debré
Reims, , France
CHU de Rouen
Rouen, , France
CHU de Strasbourg
Strasbourg, , France
CHU de Tours
Tours, , France
Countries
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Other Identifiers
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PIVeR
Identifier Type: -
Identifier Source: org_study_id
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