Diffuse-large B cell lymphoma (DLBCL)
Conditions
Interventions
Trade Name: Pixuvri®
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Pixantrone
CAS Number: 144510-96-3
Other descriptive name: PIXANTRONE
Concentration unit
Sponsors
Medical Center - University of Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained according to international guidelines and local laws 2. Male or female patients aged = 18 years without upper age limit 3. Previously untreated and histologically confirmed diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma grade 3B according to REAL/WHO classification 4. At least one objectively bi-dimensionally measurable lesion as demonstrated by CT, spiral CT, or MRI that can be followed for response as target lesion; patients with the following sites of disease are NOT eligible: - Patients with only skin lesions or only palpable lymph nodes - Patients with spleen or bone marrow as only site of disease 5. Life expectancy = 3 months according to investigator´s opinion 6. Ann Arbor stage: II-IV 7. Ability to understand the nature of the trial and the trial-related procedures and to comply with them 8. Criteria for stratification: Population 1: Age = 75 years (without limited cardiac function) not eligible for standard R-CHOP 21 treatment or Population 2: Impaired cardiac function, characterised by: First 10 patients: Ejection fraction: = 40% and = 50% Additional patients: Ejection fraction: > 30% and = 50% Note: Patients = 75 years of age with impaired cardiac function are eligible for population 2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Severe pulmonary, hepatic or renal comorbidities which make the patient ineligible for cytotoxic drug treatment 2. Severe cardiac impairment, e.g. NYHA class IV, (with the exception of inclusion criterion 8), or resting cardiac troponin T levels >0.05 ng/ml (according to > grade 1 CTCAE 3.0) which makes the patient ineligible for cytotoxic drug treatment 3. Prior treatment for lymphoma other than pre-treatment with steroids 4. History of indolent lymphoma 5. Manifestation of DLBCL disease in central nervous system (CNS) 6. Active hepatitis B or C, serologic positivity for HIV infection 7. HIV-related lymphoma 8. Immunisation with live virus vaccines within the last 14 days 9. Major thoracic and/or abdominal surgery within the 4 weeks before trial registration from which the patient has not fully recovered except for diagnosis of non-Hodgkin lymphoma (NHL); patients who have had minor surgery may be enrolled after a = 1 week recovery period except for diagnosis of NHL 10. Serious (NCI CTCAE grade 3-4) intercurrent infection at the time of trial registration or deep-seated or systemic mycotic infection. 11. Active or history of another malignancy except cured basal cell carcinoma of skin or carcinoma in situ of uterine cervix; patients who have been in remission from another previous malignancy for > 5 years will be considered eligible 12. Known hypersensitivity to pixantrone, or any drugs or excipients of the associated chemotherapy R-CPOP that the patient will receive 13. Simultaneous participation in other interventional trials and/or participation before the end of a required restriction period 14. Participation in a clinical trial within the last 30 days before being registered in this trial 15. Known or persistent abuse of medication, drugs or alcohol 16. Person who is in a relationship of dependence/employment with the sponsor or the investigator 17. For female patients of child-bearing potential: current or planned pregnancy, nursing period 18. Unwillingness to use an adequate contraception method during chemotherapy treatment until six months thereafter: for male patients (unless vasectomised): 18.1 a latex condom during sexual contact with females of childbearing potential for female patients of child-bearing potential: 18.2 mechanical method (female condom, diaphragm or coil) used in combination with a spermicide; hormonal intra-uterine device or hormonal contraception in combination with a mechanical method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of rate of complete remission after induction therapy;Secondary Objective: Assessment of: overall survival, progression-free survival, cardiac toxicity, and safety;Primary end point(s): Rate of complete remission after induction therapy as determined by PET-CT 6 weeks after last treatment (EOT visit);Timepoint(s) of evaluation of this end point: End of treatment visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival: time from start of trial treatment to death from any cause, considering patients, where the event of interest has not been observed, as censored observations. Progression-free survival: time from start of trial treatment to disease progression or death from any cause, whichever occurs first. Patients for whom the event of interest has not been observed are analysed as censored observations. Cardiac toxicity: echocardiography, ECG, troponin T, NT-proBNP during chemotherapy, at end of treatment and every 3 or 6 months during follow up; cardiac AEs according to CTCAE Safety: Rates of adverse events and serious adverse events according to CTCAE;Timepoint(s) of evaluation of this end point: endpoints: Overall survival: continuously during treatment and follow-up Progression-free-survival: continuously during treatment and follow-up Cardiac toxicity: continuously during treatment and follow-up Safety: continously during treatment phase | — |
Countries
Austria, Germany
Contacts
Public ContactClinical Trials Unit
Medical Center - University of Freiburg
Outcome results
None listed