Trial document




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  DRKS00000718

Trial Description

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Title

R-CPOP as first line therapy for elderly patients with DLBCL and for patients with limited cardiac function with DLBCL

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Trial Acronym

Pix in DLBCL first line

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URL of the Trial

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Brief Summary in Lay Language

Primary objective of the trial is a first evaluation of the efficiency of R-CPCOP (rituximab - cyclophophamide, pixantrone, vincristine, prednisone) as first line therapy for elderly patients and patients with limited cardiac function with diffuse large B-cell lymphoma (DLBCL).

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Brief Summary in Scientific Language

! Recruiting ongoing, recruiting complete was an error! The primary objective of the trial is a first evaluation of the efficiency of R-CPOP as first line therapy in patients with diffuse large B-cell lymphoma (DLBCL), measured as treatment response (CR) after induction. Two populations characterized as follows will be investigated:
I.) by age (≥ 75 years) (without limited cardiac function) or
II.) by limited cardiac function
In addition to complete remission (CR) rates, overall und progression-free survival and cardiac toxicity of this regimen will be monitored and compared to historical controls

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Organizational Data

  •   DRKS00000718
  •   2015/10/19
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  •   yes
  •   Approved
  •   562/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   2014-005069-60 
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Health Condition or Problem studied

  •   C83.3 -  Diffuse large B-cell lymphoma
  •   C82 -  Follicular lymphoma
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Interventions/Observational Groups

  •   Population 1 (age ≥ 75 years, without limited cardiac function):
    Rituximab 375 mg/m2 i.v. d0 or d1
    Cyclophosphamide 750 mg/m² i.v. d1
    Pixantrone* 88 mg/m² i.v. d1 (= 150 mg/m2 pixantrone dimaleate)
    Vincristine 1.0mg absolute i.v. d1
    Prednisone 100 mg orally d1-5

    Population 2 (patients with impaired cardiac function):
    Rituximab 375 mg/m2 i.v. d0 or d1
    Cyclophosphamide 750 mg/m² i.v. d1
    Pixantrone* 88 mg/m² i.v. d1 (= 150 mg/m2 pixantrone dimaleate)
    Vincristine 1.4 mg/m² (maximum dose 2 mg) i.v. d1
    Prednisone 100 mg orally d1-5

    *investigational medicinal product

    Treatment schedule for both populations:
    6 cycles R-CPOP every 21 days
    additional 2 cycles of rituximab (R) every 21 days
    Follow-Up per patient: 2 years
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   Yes
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Primary Outcome

Rate of complete remission after induction therapy (6 x R-CPOP + 2 x R) as assessed by PET-CT at end of treatment

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Secondary Outcome

Key secondary endpoints:

• Overall survival
• Progression-free survival

Assessment of safety:
• Cardiac toxicity (echocardiography, ECG, NT-proBNP, Troponin T, NYHA classification) at the end of treatment and every 3 or 6 months during follow up
• Adverse events (AEs) and serious adverse events (SAEs) continuously

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/02/03
  •   60
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Innere Medizin I
    • Mr.  PD Dr.  Reinhard  Marks 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Innere Medizin I
    • Mr.  PD Dr.  Reinhard  Marks 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Servier Affaires Médicales
    • 35 rue de Verdun
    • 92284  Suresnes Cedex
    • France
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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