None listed
Conditions
Interventions
Group 1 with ML Type of group
SCH 727965 40 mg / m2 is administered once every 21 days (Day 1 of each 21-day cycle) by IV infusion.
Group name:Group 2 with LLC-B Type of group
Alemtuzumab will be administered to subjects with CLL-B in the form of a 2-hour IV infusion three times a week or in the form of a subcutaneous injection administered three times a week for a total of 12 weeks. The route of administration depends on the welfare standards of the treating institution. For treatment with Alemtuzumab the dose will be adjusted to a target maintenance dose of 30 mg / day.
Sponsors
SCHERING PLOUGH DEL PERU S.A.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Measure:response rate (Complete response + partial response) of treatment with SCH 727965 and the comparator drug Timepoints:After treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as the time elapsed from the date of randomization until the first date of proven progression of the disease or death due to progression of the disease. Measure:TTP of Treatment with SCH 727965 Timepoints:After treatment ; Outcome name:It is defined as the time elapsed from the date of randomization until the first date of proven progression of the disease or death due to progression of the disease. Measure:TTP of the treatment with the comparator drug Timepoints:After treatment ; Outcome name:Based on the evaluation of adverse events, results of laboratory tests, electrocardiograms and vital signs. Measure:Safety and tolerability of treatment with SCH 727965 Timepoints:During treatment ; Outcome name:Measurement of plasma concentration and pharmacokinetic profiles Measure:Profiles of plasma concentration and pharmacokinetics of single doses of SCH 727965 after IV infusion Timepoints:During treatment ; Outcome name:Showing a> 30% decrease in standard uptake value (SUV) measurements in response to treatment with SCH 727965 compared to the SUV prior to treatment. Measure:Metabolic images obtained by FDG PET / CT Timepoints:During treatment | — |
Countries
Brazil, Canada, Peru, United States
Outcome results
None listed