Outpatients high-dose chemotherapy supported by autologus peripheral blood stem and single-dose pegfilgrastim in patients with lymphoproliferative malignances. - ND

• Conditions: patients affected by linphoproliferative pathologies; MedDRA version: 9.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disorders

• Registration Number: EUCTR2006-002971-42-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with lymphoid malignancies (diffuse large cell

lymphoma-DLCL, Hodgkin lymphoma, chronic lymphocytic

leukemia-CLL, multiple myeloma-MM or other lymphoid

malignancies indicated for autologo transplantation).

2. Target graft size (unmanipulated)

- peripheral blood: 4 - 10 x 106 CD34+ cells/kg BW recipient

3. Age > 18 and < 65 years

4. Karnofsky Index > 80 %

5. Written informed consent
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Secondary malignancies

2. Severe concomitant illnesses / medical conditions (e.g.

impaired respiratory and/or cardiac function)

3. Active infectious disease

4. HIV- positivity or active hepatitis infection

5. Impaired liver function (Bilirubin > upper normal limit;

Transaminases > 3.0 x upper normal limit)

6. Impaired renal function (Creatinine-clearance < 60 ml/min;

Serum Creatinine > 1.5 x upper normal limit).

7. Pleural effusion or ascites > 1.0 L

8. Pregnancy or lactation

9. Known hypersensitivity to Pegfilfrastim

10. Participation in another experimental drug trial within 4 weeks

before day -6

11. Non-co-operative behaviour or non-compliance

12. Psychiatric diseases or conditions that might impair the ability

to give informed consent

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluation of mortality due to febrile neutropenia; evaluation of incidence of febrile neutropenia; percentage of readmissions to the hospital due to febrile neutropenia;Secondary Objective: number of days with neutrophils below 500/mcl;Primary end point(s): a. mortality due to febrile neutropenia<br><br>b. incidence of febrile neutropenia;<br><br>c. percentage of readmissions to the hospital due to<br><br>febrile neutropenia;