A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) with the T315I BCR-ABL Gene Mutatio

• Conditions: Chronic Myeloid Leukaemia; MedDRA version: 8.1Level: LLTClassification code 10009015Term: Chronic myeloid leukemia

• Registration Number: EUCTR2006-000176-32-HU
• Lead Sponsor: Stragen France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-22
• Last Update Posted: 7 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 81

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 in peripheral blood or bone marrow, >=30% blasts + promyelocytes in peripheral blood or bone marrow, >=20% basophils in peripheral blood or bone marrow; platelet count <100 x 109/L unrelated to therapy or clonal evolution
b) CML in blast phase will be defined as >=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 will have failed prior imatinib therapy, with either primary (never achieved a response) or secondary resistance (loss of response), following imatinib therapy of at least 400 mg/day for chronic phase CML or 600 mg/day for accelerated and blast phase CML, or if such doses were not tolerated, the highest dose
tolerated in the patient.
5. 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.
6. Bilirubin = 2.0 times upper limit of normal (ULN)
ALT = 3 times ULN
Creatinine = 1.5 times ULN
7. ECOG performance status 0-2
8. Be able to comply with the requirements of the entire study
9. Be able and willing to provide written informed consent prior to any study related procedure. (In the event that the patient is rescreened for study participation or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed.)
10. Sexually active patients and their partners must use an effective double barrier method of contraception associated with a low failure rate (i.e., less than 1% per year) during and for six months after completion of study therapy. The following are considered effective contraceptives: (1) oral contraceptive pill, (2) condom, (3) diaphragm plus spermicide, (4) abstinence, (5) patient or partner surgically sterile, (6) patient or partner more than 2 years post-menopausal or (7) injectable or implantable agent/device

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

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
7. Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent
8. Patient is a candidate for bone marrow or stem cell transplantation

Study & Design

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