A clinical trial to test the safety and effectiveness of a new drug, tefinostat, for patients with chronic myelomonocytic leukaemia

Phase 1

• Conditions: Chronic myelomonocytic leukaemia (CMML); MedDRA version: 19.0Level: PTClassification code 10009018Term: Chronic myelomonocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002281-23-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-19
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients with newly-diagnosed or previously-treated CMML meeting WHO criteria with the following characteristics will be eligible for the study:

1. All CMML-2 patients are eligible
2. For patients classified as CMML-1, the following must be present:

• Symptomatic bone marrow failure / myeloproliferation defined as one or more of: red cell transfusion dependence with pre-transfusion Hb <90g/l, symptomatic anaemia (Hb <115g/l), thrombocytopenia (platelets <50 x 109/l), mptomatic bleeding due to platelet function defect or DIC/fibrinolysis, hite blood cell count >50 x 109/l

and/or

• CMML-specific Prognostic Score (CPSS) of intermediate-2 or high risk (16)
(details of derivation of CPSS score given below)

and/or

• Systemic symptoms including weight loss with no alternative explanation (10% of baseline weight within previous 6 months)
• Symptomatic splenomegaly
• Symptomatic extrameduallary involvement, eg. skin infiltration, serous effusions

3. Subject is able and willing to sign the Informed Consent Form
4. Age greater than or equal to 18 years at the time of signing the Informed Consent Form
5. Willingness to undergo scheduled assessments as per the study protocol including bone marrow assessments
6. ECOG performance status of 0-2 at study entry
7. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to starting study drug
8. Women of childbearing potential must use at least two effective contraceptive methods throughout the study and for three months following the date of the last dose of study drug
9. Men whose partner is a woman of childbearing potential must use at least two effective contraceptive methods

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

1. CMML with eosinophillia and 5q33 abnormality
2. Previous chemotherapy for CMML except Hydroxycarbamide and 5-azacitidine
3. Creatinine concentration > 2x the institutional upper limit of normal range
4. Liver transaminases (AST / ALT) > 3x the institutional upper limit of normal range or serum bilirubin > 4x the institutional upper limit of normal range
5. Pregnant or lactating females
6. Use of experimental drug or therapy within 28 days of registration
7. Other malignancy within the last 3 years other than curatively-treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated non-metastatic prostate cancer with negative prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional
cell bladder carcinoma
8. Known seropositivity for HIV infection or infectious hepatitis (type B or C)
9. Uncontrolled inter-current illness including, but not limited to, ongoing infection, psychiatric illness or social situation that the treating physician judges would limit compliance with study requirements

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified