A Phase Ib study of lenalidomide in combination with imatinib for adult patients with chronic myeloid leukaemia in second molecular remission

South Australian Health & Medical Research Institute (SAHMRI)0 sites3 target enrollmentNovember 2, 2015

Overview

No summary available.

Registry

who.int

Start Date

November 2, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

South Australian Health & Medical Research Institute (SAHMRI)

•1\. Diagnosis of chronic myeloid leukaemia associated with BCR\-ABL quantifiable by RQ\-PCR at the time of commencing imatinib therapy.
•2\. Patient experienced molecular recurrence of BCR\-ABL during a previous medically supervised period of imatinib withdrawal, resulting in resumption of imatinib treatment, and:
•a. MR4\.5 at the time of having previously stopped imatinib.
•b. No more than two BCR\-ABL results above 0\.01% in the two year period prior to having stopped imatinib.
•c. Willing and able to provide all BCR\-ABL RQ\-PCR results from the two year period prior to having stopped imatinib, and for the period up to the time of restarting imatinib treatment.
•3\. Patient regained MR4\.5 after restarting imatinib treatment (as detailed in criterion 3\) and has maintained MR4\.5 on at least 2 tests in the 12 months prior to screening, and:
•a. No BCR\-ABL result above 0\.1% (MMR) in the 12 month period prior to screening.
•b. No more than one BCR\-ABL result above 0\.01% in the 12 month period prior to screening.
•c. Willing and able to provide copies of all BCR\-ABL RQ\-PCR test results from the 12 month period prior to screening.
•4\. Currently taking imatinib and no other current or planned anti\-leukaemia therapies.

•1\. Patient has received another investigational agent for treatment of CML within last 12 months.
•2\. Atypical BCR\-ABL transcript not quantifiable by standard RQ\-PCR.
•3\. Another primary malignant disease, except those which do not currently require treatment (adequately treated conditions, such as excised non\-melanoma skin cancer or cervical intra\-epithelial neoplasia would not be considered exclusion criteria. If in doubt, please refer to the Principal Investigator).
•4\. Another severe and/or life\-threatening medical disease.
•5\. Active liver disease (e.g., chronic active hepatitis, cirrhosis).
•6\. History of deep venous thrombosis (in the case of clearly provoked thrombosis more than 2 years prior, please refer to the Principal Investigator).
•7\. Known diagnosis of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
•8\. History of non\-compliance or inability to grant informed consent.
•9\. Prior allogeneic stem cell transplantation.