Study of pixantrone in patients with lymphoma.

Phase 1

• Conditions: Patients with CD20-positive relapsed or refractory aggressive non-Hodgkin lymphoma; MedDRA version: 20.0Level: HLTClassification code 10029608Term: Non-Hodgkin's lymphomas unspecified histology aggressiveSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000719-17-BE
• Lead Sponsor: YSARC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-10
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

1 - Histologically proven CD20+ aggressive non-Hodgkin lymphoma (diffuse large B-cell lymphoma (DLBCL), de novo or transformed DLBCL from previously low grade non-Hodgkin lymphoma or grade 3b follicular lymphoma) note previously treated with more than 2 lines of cytotoxic agents before transformation, as per the WHO 2016 criteria agents

2 - Relapsed or refractory disease, defined as follows:
a. Patients eligible for ASCT who failed to achieve a CR after at least one salvage therapy (eg, R-ICE, R-ESHAP, or R-DHAP), patients who were previously refractory to R-ICE (stable disease or progressive disease) are not eligible to the study).
b. Or patients in first relapse after ASCT
c. 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 between 18 and 79 years included, at the time of informed consent signature

4 - Eastern Cooperative Oncology Group (ECOG) performance status under or equal to 2

5 - Subjects must have evaluable disease based on 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

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 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1 - Any other histological type of lymphoma (Burkitt lymphoma, mantle-cell lymphoma…)
2- Any history of indolent NHL previously treated by more than 2 lines of cytotoxic agents before transformation
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:
a. Absolute neutrophil count (ANC) < 1.0 G/L
b. Platelet count < 100 G/L
c. Creatinine clearance < 40 mL/min for patients < 70 y, or creatinine clearance < 60 mL/min for patients = 70 y., by MDRD method
d. Total bilirubin level > 1,5xULN
e. Serum AST/SGOT or ALT/SGPT > 2,5x ULN
7 - Known HIV positive
8 - Active hepatitis C (Positive HCV serology with positive PCR for HCV RNA)
9 - Active hepatitis B :
a. HBsAg positive
b. HBsAg negative, Ac anti-HBs positive and/or Ac anti-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 VHB DNA is negative)
10 - Cumulative dose of doxorubicine or equivalent > 450mg/m2
11 - Left ventricular ejection fraction (LVEF) < 45% measured by echocardiography or isotopic method
12 - Congestive heart failure NYHA stage III or IV
13 - History of a myocardial infarction within 6 months prior to enrolment
14 - Pregnant or lactating females
15 - Prior history of other malignancies with the exception of non-melanoma skin tumors (basal cell or squamous cell carcinoma) or in situ cervical carcinoma unless the patient has been free of the disease for = 3 years after curative treatment including surgical resection, chemotherapy or radiotherapy.
16 - Any serious active disease or co-morbid medical condition according to the investigator’s decision
17 - Adult person unabled to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
18 - Use of any standard or experimental anti-cancer drug therapy within 28 days before the first study drug administration and any evolutive toxicity that could interfere with the assessment of the safety profile of the trial
19 - Use of corticosteroids prior to baseline PET-CT

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified