R-CPOP (Rituximab plus Cyclophosphamid, Pixantron, Vincristin, Prednison) as first line therapy for elderly patients with diffuse-large B cell lymphoma (DLBCL) and for patients with limited cardiac function with DLBC

Phase 1

• Conditions: Diffuse-large B cell lymphoma (DLBCL); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005069-60-DE
• Lead Sponsor: Medical Center - University of Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-30
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

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