Clinical trial NCT01085058: Predictive Value of the "Cytocapacity Test" Patients With Lymphoproliferative Diseases and High-dose Therapy
Official title: Predictive Value of the "Cytocapacity Test" Following a Single-dose of rHu-G-CSF in Patients With Lymphoproliferative Diseases and High-dose Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hodgkin's Disease
Non-Hodgkin Lymphomas
Multiple Myelomas
Keywords: Lymphoproliferative diseases (Hodgkin's disease, non-Hodgkin's lymphomas, multiple myelomas) and high-dose therapy
Lead sponsor: WiSP Wissenschaftlicher Service Pharma GmbH
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
name: Chugai Pharma GmbH
First posted: 2010-03-11
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This investigator initiated trial was a prospective, open, single-arm, diagnostic-prognostic study. Patients who received high-dose therapy with autologous stem cell transplantation for the treatment of their lymphoproliferative disease were included into the study.

After completion of the high-dose therapy (day -2 with respect to the stem cell transplantation) the first blood sample A for the cytocapacity test with determination of leukocytes and neutrophils was taken in the evening of day -1. Directly thereafter the study medication was administered. The second blood sample B for the cytocapacity test with determination of leukocytes and neutrophils was taken in the morning of day 0, 12-14 hours after administration of the study medication. Thereafter the stem cell re-infusion was performed.

The primary objective of this study was to show that the cytocapacity test with lenograstim is a useful predictive tool with respect to the risk of post-transplant complications and prolonged myelosuppression, typically occurring after high-dose chemotherapy.

The primary variables were:

* the rate of patients with documented infections
* the time to platelet engraftment


Eligibility criteria: Inclusion Criteria:

* Presence of histologically proven lymphoproliferative disease specified as Hodgkin's disease, non-Hodgkin's lymphoma (NHL) or multiple myeloma
* Indication of high-dose therapy and autologous peripheral blood stem cell transplantation
* Availability of a sufficient amount of blood stem cells (CD34+ cells \>= 2.0 x 106/kg)
* Age between 18 and 70 years
* High-dose therapy with one of the following high-dose regimes: Melphalan 140 mg/m2 or 200 mg/m2, BEAM, BEAC, BUCY or CBV (the last permitted according to amendment 2, see Section 9.8.1)
* Patient's written consent to participation in this trial

Exclusion Criteria:

* Previous high-dose therapy and blood stem cell transplantation except for melphalan 140 mg/m2 or 200 mg/m2 in patients with multiple myeloma who did not participate in the cytocapacity test previously (according to amendment 2, see Section 9.8.1).
* Known intolerance to lenograstim
* Out-patient therapy following high-dose therapy and blood stem cell transplantation
* Myocardial infarction \< 6 months prior to inclusion into the study
* Cardiac arrhythmias Lown IV b
* Clinically manifest cardiac insufficiency (\> NYHA II)
* Renal insufficiency with serum creatinine \> 2 mg%
* Hepatic diseases with elevated levels of transaminases and bilirubin greater than 3-fold above normal
* Severe infections (HIV, Hepatitis B/C)
* Severe psychiatric diseases
* Non-curative treatment of other malignoma within the past 5 years
* Pregnant women or women breast-feeding

Primary outcomes:
measure: Incidence of infections
measure: Time to platelet engraftment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Straka C, Sandherr M, Salwender H, Wandt H, Metzner B, Hubel K, Silling G, Hentrich M, Franke D, Schwerdtfeger R, Freund M, Sezer O, Giagounidis A, Ehninger G, Grimminger W, Engert A, Schlimok G, Scheid C, Hellmann P, Heinisch H, Einsele H, Hinke A, Emmerich B. Testing G-CSF responsiveness predicts the individual susceptibility to infection and consecutive treatment in recipients of high-dose chemotherapy. Blood. 2011 Feb 17;117(7):2121-8. doi: 10.1182/blood-2010-06-290080. Epub 2010 Dec 16.