Efficacy and Safety Study of Dasatinib in Patients With Chronic Myeloid Leukemia

NCT00895297 | Terminated Phase 2 DMC

• 2 other identifiers: 2008-001361-29CLWP-001-2008
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 7

Brief Summary

This is a phase II efficacy (indicates the capacity for beneficial change or therapeutic effect) and safety study of Dasatinib in patients with relapsed Chronic Myeloid Leukemia (CML) following a Stem Cell Transplant (SCT) and who are not benefiting from other treatment, such as imatinib therapy. A relapse is when an illness that has seemed to be getting better, or to have been cured, comes back or gets worse again. A total of 50 patients ≥18 years of age will be registered on the trial.

Conditions

Chronic Myeloid Leukemia

Keywords

Relapsing after allogeneic transplantation; Dasatinib; Sprycel; Philadelphia Chromosomes

Outcome Measures

Primary Outcomes (1)

• CMR as determined by two consecutive (-) RT-PCR tests for the presence of BCR-ABL transcripts in peripheral blood samples 1 year after starting Dasatinib therapy. The expected CMR of >30% would be regarded as being clinically relevant

  4 years

Secondary Outcomes (8)

• Complete haematological response (CHR) at 3 months post commencing Dasatinib for those that have relapsed at the haematological level.

  4 years

• Complete cytogenetic response (CCyR) at 6 and 12 months post commencing Dasatinib for those that have relapsed at the cytogenetic level.

  4 years

• Major molecular response (MMR) at 12 months post commencing Dasatinib for all patients.

  4 years

• Proportion of patients requiring DLI during the first 12 months

  4 years

• Overall survival (OS) - Limited to 3 years.

  4 years

Interventions

Dasatinib (Sprycel) DRUG

100mg of Dasatinib will be administered as tablets, by mouth, once a day (or twice in some cases depending on the stage of the disease) consistently either in the morning or evening for 12 months. Dose of Dasatinib will be modified according to the patients response.

Eligibility Criteria

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

You may qualify if:

• Male or female patients greater or equal to 18 years of age.
• Diagnosed with BCR-ABL (+) Chronic Myeloid Leukemia (they can be Philadelphia chromosome positive or negative)
• Prior therapy including imatinib
• Patients transplanted from an HLA-identical sibling or an HLA-matched unrelated donor.
• Patients transplanted in first chronic phase or accelerated phase.
• Patients with untreated relapse of BCR-ABL (+) CML (they can be Philadelphia chromosome positive or negative) after allogeneic transplantation and entered within 6 weeks of the first detection of relapse.
• Molecular, cytogenetic or haematological relapse in chronic or accelerated phase.
• Written informed consent.
• Absence of serious concomitant illness

You may not qualify if:

• Patients relapsing in blast crisis.
• Patients transplanted after blastic transformation of CML.
• Patients receiving any therapy for relapse other than withdrawal of immunosuppression (DLI is not permitted).
• Patients treated with other investigational agents during the previous 30 days
• Patients previously treated with Dasatinib.
• Absence of written informed consent.
• Presence of serious concomitant disease.
• History of a significant bleeding disorder unrelated to CML.
• Pregnancy or lactation status positive.
• SGOT and SGPT more than 2.5 x the upper limit of the normal range as determined by the laboratory where the analysis is performed.
• Total serum bilirubin level more than 2 x the upper limit of the normal range of the laboratory where the analysis is performed.
• Serum creatinine concentration more than 1.5 x the upper limit of the normal range of the laboratory where the analysis is performed.
• Category I drugs that are generally accepted to have a risk of causing Torsades de Points including: (Patients must discontinue drug 7 days prior to starting Dasatinib):
• quinidine, procainamide, disopyramide.
• amiodarone, sotalol, ibutilide, dofetilide.

Sponsors & Collaborators

• European Society for Blood and Marrow Transplantation: lead
• Bristol-Myers Squibb: collaborator

Study Sites (7)

E Herriot Hospital

Lyon, France

Location

University Hospital

Hamburg, Germany

Location

Uniklinik Leipzig

Leipzig, Germany

Location

Stiftung Deutsche Klinik für Diagnostik

Wiesbaden, Germany

Location

University Hospital

Basel, 4031, Switzerland

Location

Hopitaux Universitaires de Geneve

Geneva, Switzerland

Location

Hammersmith Hospital

London, W12 0NN, United Kingdom

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Eduardo L Olavarria, Dr

  Hospital De Navarra Irunlarrea, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 8, 2009
• Study Start: February 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 7, 2011

Record last verified: 2011-12

Locations

GB (1); DE (3); CH (2); FR (1)