A trial to test if decitabine can be used to treat patients with Myelodysplastic Syndrome (MDS) that have already been treated with Azacitidine (AZA)

Phase 1

• Conditions: Myelodysplastic Syndromes Acute Myeloid Leukaemia Chronic Myelomonocytic Leukaemia; MedDRA version: 14.1 Level: LLT Classification code 10054350 Term: Chronic myelomonocytic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: PT Classification code 10009018 Term: Chronic myelomonocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2009-017098-40-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-29
• Study Completion: 2014-08-14
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1.Written signed informed consent.
2.18 years of age or older
3.At study entry, diagnosed MDS with 5% or more marrow blasts and IPSS risk intermediate 2 or high risk; or chronic myelomonocytic leukemia (CMML-2); or AML with 20-30% bone marrow blasts (previously defined as RAEB-t by the FAB MDS classification).
4.Patients who have failed therapy with azacitidine* see definition below.
5.Performance status 0-2 (ECOG scale).
6.Adequate hepatic (bilirubin < 1.5 X ULN or AST< 2.5 X ULN) and renal functions (creatinine <1.5 X ULN).

*Failure of treatment with 5-azacitidine is defined as:

1.Refractory
Progression, immediately and without reaching prior response (CR, PR, mCR, HI), under therapy with 5-azacitidine given for at least 6 cycles

2.Relapsed on therapy
Progression, after prior response (CR, PR, mCR, HI, SD), under therapy with 5-azacitidine

3.Relapsed off therapy
Patients who had previously attained a response (CR, PR, mCR, HI, SD) while on 5-azacitidine, but have subsequently relapsed within 3 months from last 5-azacitidine course

4.Toxicity failure
5-azacitidine-related non-haematological toxicity precluding its further administration

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Patients with >30% bone marrow blasts at study entry.
2.Nursing and pregnant females.
3.Women of childbearing potential (WCBP) † and males not willing to practice an effective method of contraception whilst receiving decitibine and for 2 months after the last infusion.
† A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or bilateral oopherectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).
4.Patients with concurrent malignancy.
5.Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
6.Ongoing oral corticosteroids are not permitted. However, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
7.Patients who have received any investigational agent within the 30 days preceding the first dose of study drug.
8.Patients who have received prior intensive combination chemotherapy or high-dose cytarabine (>/= 1g/m*2 per dose) for the treatment of MDS or AML. (Prior biologic therapies, targeted therapies and single agent chemotherapy are allowed).
9.Patients who have an active viral or bacterial infection. Note: No patient is allowed to enter the study unless infections have been fully treated and the patient has remained afebrile for 7 days without antibiotics.
10.Patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.
11.Patients who have previously been treated with decitabine.
12.Patients who have known positive serology for HIV.
13.Patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.

Study & Design

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