PHASE II STUDY OF BMS-354825 IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA IN A BLASTIC LYMPHOID PHASE OR WITH ACUTE LYMPHOBLASTIC LEUKEMIA POSITIVE PHILADELPHIA CHROMOSOME THAT ARE REFRACTORY OR INTOLERANT TO THE IMATINIB MESILATE TREATMENT

Not Applicable

• Conditions: -C929 Myeloid leukaemia, unspecified-C919 Lymphoid leukaemia, unspecified; Lymphoid leukaemia, unspecified; Myeloid leukaemia, unspecified; C919; C929

• Registration Number: PER-016-05
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Patients must provide written informed consent.
2) Subjects with chronic myeloid leukemia in the blastic lymphoid phase that are Ph + chromosome (or BCR / ABL-h), whose disease has primary or acquired haematological resistance to imatinib mesylate, or are intolerant to imatinib mesylate.
3) Available for a scheduled follow-up.
4) Score of 0 - 2 in the performance status ECOG
5) Adequate liver function.
6) Adequate renal function.
7) Serum levels of potassium and magnesium within normal institutional limits.
8) Men and women 18 years of age or older.

Exclusion Criteria

1) MEF that are not willing or able to use a method of birth control that is acceptable.
2) MEF who are using a prohibited contraceptive method.
3) MEF who are pregnant or breastfeeding.
4) Women who have obtained a positive result in the pregnancy test performed during enrollment.
5) Sexually active men whose sexual partners may become pregnant, who are unwilling or unable to use a method of birth control
that is acceptable.
6) Subjects who are eligible and willing to undergo a transplant during the selection period.
7) Severe non-controlled medical condition or active infection that could impair the possibility of the subject receiving the protocol therapy.
8) Significant or uncontrolled cardiovascular disease.
9) Dementia or mental state altered that would prevent understanding the informed consent.
10) History of significant hemorrhagic disorder not associated with CML.
11) Concurrent incurable neoplasia different from CML.
12) Evidence of orogenic dysfunction or digestive dysfunction that would prevent the administration of therapy.
13) Subjects who received: Imatinib mesylate in the 7 days prior to admission, Interferon in the 14 days prior to admission, antineoplastic molecule therapy within 14 days prior to admission, any other antineoplastic or investigational drug.
15) Individuals who are taking medications that irreversibly inhibit platelet function

Study & Design

• Study Type: Interventional
• Study Design: Not specified