Predictive Value of the "Cytocapacity Test" Patients With Lymphoproliferative Diseases and High-dose Therapy (CU01)

WiSP Wissenschaftlicher Service Pharma

Status and phase

Completed

Phase 3

Phase 2

Conditions

Non-Hodgkin Lymphomas

Hodgkin's Disease

Multiple Myelomas

Treatments

Drug: lenograstim

Study type

Interventional

Funder types

Other

Identifiers

NCT01085058

WISP_CU01

Details and patient eligibility

About

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

Enrollment

169 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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