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

NCT01085058 | Completed Phase 2

• 1 other identifier: WISP_CU01
• Study Type: interventional
• Target: 169
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

Primary Outcomes (2)

• Incidence of infections

• Time to platelet engraftment

Study Arms (1)

A: lenograstim

EXPERIMENTAL

total group

Drug: lenograstim

Interventions

lenograstim DRUG

A: lenograstim

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• WiSP Wissenschaftlicher Service Pharma GmbH: lead
• Ludwig-Maximilians - University of Munich: collaborator
• Chugai Pharma GmbH: collaborator

Related Publications (1)

• 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.

  PMID: 21163927 DERIVED

MeSH Terms

Conditions

Hodgkin Disease; Multiple Myeloma

Interventions

Lenograstim

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: May 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: March 11, 2010

Record last verified: 2010-03