Safety and Tolerability Open Label Dose Escalation Study of Acadesine in B-CLL Patients

NCT00559624 | Completed Phase 1 DMC

• 1 other identifier: ATH001-CLN01
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 8

Brief Summary

The main aim of this study is to test the safety of acadesine in patients with B-CLL and see what effects it has on patients and their leukaemia. The study also aims to examine the way acadesine is processed by the body. The study will look at the effects of acadesine in the body and the concentration of the drug and its main by-product (ZMP) in the blood to determine the dose and the frequency of dosing that is likely to be the most effective.

Conditions

Leukemia, B-Cell, Chronic

Keywords

safety; tolerability; dose-escalation

Outcome Measures

Primary Outcomes (1)

• adverse event and serious adverse events(incidence, causality, severity), local tolerability (including liver enzymes, blood glucose and uric acid) and vital signs.

  up to and including Day 22 follow up visit

Interventions

Acadesine DRUG

For part I of the study one 4 hour intravenous infusion will be given. In part II upto five 4 hour intravenous infusions will be given over 20 days.

Also known as: Acadra

Eligibility Criteria

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

You may qualify if:

• B-CLL patients with refractory or relapsed disease who have received one or more (≥ 1) prior lines of treatment which must have included either a fludarabine based regimen or an alkylator based regimen. Refractoriness is defined as any patient who has failed to achieve a CR, nPR or PR according to the National Cancer Institute (NCI) working group guidelines for CLL. Fludarabine refractoriness will also include patients who achieved a CR, nPR or PR of ≤ 6 months duration.
• Diagnosis of B-CLL according to NCI Working Group Criteria.
• Have an elevated B-cell count of ≥ 5000/mm3.
• Have a T-cell count ≥ 200/mm3.
• ECOG Performance Status ≤ 2.
• Have a life expectancy of at least 3 months.
• Age ≥ 18 years, of either gender.
• Have given written informed consent, prior to any study related procedure not part of the patient's normal medical care
• Receive allopurinol prophylaxis for hyperuricaemia.

You may not qualify if:

• Patients who, in the opinion of the Investigator, need immediate treatment with proven chemotherapy and/or immunotherapy, and/or transplantation.
• Have B-CLL with central nervous system involvement.
• Have participated in any other investigational drug study or have undergone an experimental therapeutic procedure considered to potentially interfere with the study in the 30 days preceding Day 1.
• Have received chemotherapy or radiotherapy treatment in the 30 days preceding Day 1.
• Require oral or parenteral steroids with the exception of inhaled steroids or low-dose oral steroids (\<10mg prednisolone per day or equivalent) for an indication other than B-CLL.
• Have a serious medical or psychiatric condition that could, in the Investigator's opinion, potentially interfere with their treatment and/or participation in the study.
• Have uncontrolled diabetes mellitus
• Have a history of gout.
• Have a serious concomitant disease including:
• Significant cardiac disease - New York Heart Association Classes III or IV or have suffered a myocardial infarction in the last 6 months.
• Chronic pulmonary obstructive disease with hypoxemia.
• Clinically active auto-immune disease.
• Active infection such as tuberculosis, CMV (Cytomegalovirus).
• Any secondary malignancy requiring active treatment (except hormonal therapy).
• Have inadequate bone marrow reserve: neutrophils \< 1.0 x 109/L, platelet count \< 50 x 109/L (unsupported by transfusion), or coagulation abnormalities.

Sponsors & Collaborators

• Advancell - Advanced In Vitro Cell Technologies, S.A.: lead
• Nexus Oncology Ltd: collaborator

Study Sites (8)

Hematology Department, ZNA Stuivenberg

Antwerp, Belgium

Location

Cliniques universitaires Saint-Luc Haematology Dept

Brussels, Belgium

Location

Hematology Department UZ Gasthuisberg

Leuven, Belgium

Location

Hôpital Avicenne

Bobigny, France

Location

Service des maladies du sang Hôpital HURIEZ, CHRU

Lille, France

Location

Hematologia Clinica, Institut Catala d'Oncologia

Barcelona, 08907, Spain

Location

Hospital Madrid Nortesanchinarro

Madrid, 28050, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

acadesine

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Van Den Neste, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 10, 2011

Record last verified: 2011-05

Locations

ES (3); BE (3); FR (2)