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

Primary Purpose

Hodgkin's Disease, Non-Hodgkin Lymphomas, Multiple Myelomas

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

lenograstim

About this trial

This is an interventional diagnostic trial for Hodgkin's Disease focused on measuring Lymphoproliferative diseases (Hodgkin's disease, non-Hodgkin's lymphomas, multiple myelomas) and high-dose therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A: lenograstim

Arm Description

total group

Outcomes

Primary Outcome Measures

Incidence of infections

Time to platelet engraftment

Secondary Outcome Measures

Full Information

NCT ID

NCT01085058

First Posted

March 10, 2010

Last Updated

March 10, 2010

Sponsor

WiSP Wissenschaftlicher Service Pharma GmbH

Collaborators

Ludwig-Maximilians - University of Munich, Chugai Pharma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01085058

Brief Title

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

Acronym

CU01

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

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

WiSP Wissenschaftlicher Service Pharma GmbH

Collaborators

Ludwig-Maximilians - University of Munich, Chugai Pharma GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin's Disease, Non-Hodgkin Lymphomas, Multiple Myelomas

Keywords

Lymphoproliferative diseases (Hodgkin's disease, non-Hodgkin's lymphomas, multiple myelomas) and high-dose therapy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

169 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: lenograstim

Arm Type

Experimental

Arm Description

total group

Intervention Type

Drug

Intervention Name(s)

lenograstim

Primary Outcome Measure Information:

Title

Incidence of infections

Title

Time to platelet engraftment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Citations:

PubMed Identifier

21163927

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.

Results Reference

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

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