SCH 727965 in Patients With Mantle Cell Lymphoma or B-Cell Chronic Lymphocytic Leukemia (Study P04715)
- Conditions
- -C851 B-cell lymphoma, unspecified-C911 Chronic lymphocytic leukaemia of B-cell typeB-cell lymphoma, unspecifiedChronic lymphocytic leukaemia of B-cell typeC851C911
- Registration Number
- PER-048-08
- Lead Sponsor
- SCHERING PLOUGH DEL PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 2
• The subjects must be 18 years of age or older, and belong to any sex and race.
• Subjects must have a diagnosis of LM according to the criteria of the World Health Organization (pMS), or B-CLL checked according to the criteria of! working group of the National Cancer Institute of the United States (NCI-WG.
• Subjects must meet the requirements listed below with respect to previous chemotherapy treatment: For LW1: they must have received at least one previous chemotherapy treatment, but no more than two previous regimens including stem cell transplantation. For LLC-B; they must have previously received at least one treatment based on an alkylating agent and a regimen containing fludarabine, but must not have received more than two previous treatments.
• Subjects must have measurable disease or be evaluated by the Revised Response Criteria for Malignant Lymphomas in the case of subjects with SCI or by the criteria of the NCI-WG group in the case of subjects with B-CLL.
• The subjects must have a general status of 0, 1 or 2 on the scale of the Eastern Cooperative Oncology Group (ECOG).
• The subjects must have an adequate organic function and laboratory parameters that include: a. Absolute neutrophil count> 1.0 x 10 9 / L; b. Platelet count> 50 x 10 9 / L: c. Serum creatinine <2 times the upper limit of normal (ULN) or calculated creatinine clearance> 50 mL / min; d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 times ULN; and. Total bilirubin <2 times e! ULN
• Subjects (and / or the legally acceptable representative of a subject with an inability to independently consent) must be willing to give written informed consent and be able to comply with the dose and visit schedule.
• Women of childbearing age or men and their female sexual partners of childbearing age, who are currently having sexual intercourse, must agree to use a medically acceptable method of contraception before their incorporation, while they are receiving the medication specified in the protocol, and for 6 months after stopping the medication Acceptable methods of contraception include double barrier methods such as condoms (male or female) combined with spermicide or diaphragm or cervical plug with spermicide; or intrauterine device Indicated by medical prescription. Contraceptive medication (ie, oral contraceptives), vasectomy, and tubal ligation should be considered, separately, as simple barrier methods.
• Women of childbearing age or men and their female sex partners of childbearing age without current sexual activity should agree to use a medically acceptable method of contraception if they decide to have sex while participating in the study
• Subjects with LM or LLC-B with confirmed involvement of the central nervous system.
• Subjects who have received some radiotherapy within 4 weeks prior to the start of treatment.
• Subjects with a history of a second malignant tumor. Nonmelanoma skin cancer or carcinoma in situ of the cervix treated with curative intent at least 2 years before the start of treatment or another malignancy properly treated and from which the subject has remained free for> 5 years is accepted.
• Subjects with LM will be excluded for any of the following reasons: a. pretreatment with bortezomib; b. confirmed hypersensitivity to bortezomib, boron, or mannitol.
• Subjects with CLL-B will be excluded by any of the following reasons: a. previous treatment with aiemtuzumab; b. confirmed hypersensitivity to aiemtuzumab or its excipients; c. Leukocyte count> 200 x 10 ^ / L. Note: If there is no evidence of tumor lysis syndrome in the first 10 subjects treated with SCH 727965, subjects with a white blood cell count> 200 x 10® / L will be allowed to enroll.
• Subjects who have received prior treatment with SCH 727965 or other CDK inhibitors.
• Subjects with allergy / sensitivity to SCH 727965 or its excipients.
• Subjects who have received any of the treatments listed in Table 2 before the indicated period of pharmacological rest has elapsed prior to the start of treatment or who must continue receiving treatment listed in Table 2.
• Subjects without resolution of the toxic effects of the previous treatment (the incorporation of subjects with Grade 1 residual toxicity resulting from the previous treatment may be considered, after analyzing it with the sponsor).
• Subjects with confirmed human immunodeficiency virus.
• Subjects with hepatitis B or active hepatitis C confirmed.
• Subjects with any serious or uncontrolled infection.
• Women who are breastfeeding, pregnant or expect to become pregnant.
• Subjects with any situation or clinically significant condition, other than the one being studied that, in the opinion of the researcher, would interfere with the study´s evaluations or the optimal participation in the study.
• Subjects with little probability of completing the study and the corresponding follow-up visits.
• Subjects who are receiving concomitant treatment in any other clinical study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Determined using the Revised Response Criteria for Malignant Lymphomas in the case of the LM, and the Revised Guidelines of the NCI-WG group in the case of the LLC-B.<br>Measure:response rate (Complete response + partial response) of treatment with SCH 727965 and the comparator drug<br>Timepoints:After treatment<br>
- Secondary Outcome Measures
Name Time Method