Chronic Myeloid Leukaemia
Conditions
Interventions
Product Name: Ceflatonin
Product Code: HHT
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 26833-87-4
Other descriptive name: HHT
Concentration unit: mg milligram(s)
Con
Sponsors
Stragen France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, age 18 years or older 2. Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase. a) Patients in accelerated phase will meet one or more of the following criteria: >=15% - =30% blasts + promyelocytes in peripheral blood or bone marrow, >=20% basophils in peripheral blood or bone marrow; platelet count =30% blasts in the bone marrow or presence of extramedullary disease. c) All other patients will be considered to have chronic phase CML 3. The patient will have the T315I BCR-ABL gene mutation. 4. Patients must have completed all previous anti-leukemic therapy for at least 2 weeks, prior to the first planned dose of HHT, except as noted below, and must have fully recovered from side effects of a previous therapy, unless disease progression necessitates early therapy. In patients with rapidly proliferating disease, hydroxyurea may be administered during the first two cycles of treatment, if clinically indicated, to control disease. In such cases, complete hematologic response (CHR) must be sustained for >= 4 weeks for accelerated and blast phase CML and for >= 8 weeks for chronic phase CML, following the discontinuation of hydroxyurea, to be considered as a CHR. Patients may receive anagrelide for up to 28 days (in countries where the product is registered). Leukapheresis is allowed up to 24 hours prior to registration. 5. Bilirubin = 2.0 times upper limit of normal (ULN) ALT = 3 times ULN Creatinine = 1.5 times ULN 6. ECOG performance status 0-2. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension or congestive heart failure. 2. Myocardial infarction in the previous 12 weeks. 3. Other concurrent illness which would preclude study conduct and assessment, including but not limited to another active malignancy (excluding squamous or basal cell skin cancer and in situ cervical cancer), uncontrolled and active infection, positive HIV status or positive HTLV I/II status. 4. Pregnant or lactating. 5. Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol. 6. Lymphoid Ph+ blast crisis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of subcutaneous administration of homoharringtonine (HHT) (omacetaxine) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have the T315I BCR-ABL gene mutation;Secondary Objective: ;Primary end point(s): The primary endpoint will be the proportion of patients achieving a clinical response, defined for each patient subpopulation, as follows: Chronic phase CML: Achievement of a complete hematologic response (CHR) or major cytogenetic response (complete or partial response, up to 35% Ph+ metaphases). The response must last >= 8 weeks to be considered meaningful. Accelerated phase CML: Achievement of either a complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase CML. The response must last >=4 weeks to be considered meaningful. Cytogenetic responses will also be evaluated. Blast phase CML: Achievement of either a complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase CML. The response must last >= 4 weeks to be considered meaningful. Cytogenetic responses will also be evaluated. | — |
Countries
Germany, Hungary, Italy, United Kingdom
Outcome results
None listed