CML and Ph+ALL MedDRA version: 8.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia
Conditions
Interventions
Product Name: MK-0457
Product Code: MK-0457
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75 per
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is male or female, and =18 years of age on day of signing informed consent; ECOG performance status as stated in the protocol; The interval from prior treatment (standard or investigational) to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for non-cytotoxic agents. The only exception is hydroxyurea which can be used to control peripheral leukemic cell counts prior to initiating study drug and during the first treatment cycle. Persistent clinically significant chronic toxicities from prior chemotherapy must not be greater than Grade 2 (except alopecia); Patient must have proper organ function as outlined in the protocol; Patients under consideration for inclusion into this study must have Ph+ (or BCR-ABL+) CML or ALL and meet one of the following disease inclusion criteria; Patients with documented BCR-ABL T315I mutation; 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: Patient has not fully recovered from acute side effects of prior anti-leukemic therapy to = Grade 2 toxicity, except alopecia; Patient within 3 months of allogeneic bone marrow transplant and/or has active and uncontrolled Graft-versus-Host disease following allogeneic bone marrow transplant and/or not on a stable dose of immunosuppressants for at least one month; Patient has uncontrolled symptomatic congestive heart failure, angina, or had a myocardial infarction in the preceding 3 months; Patient has known hypersensitivity to the components of study drug or its analogs; Patient has uncontrolled active infection; Patient has a known psychiatric or substance abuse disorder that in the opinion of the Investigator would interfere with cooperation with the requirements of the trial; Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the study; Patient has any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study; Patients with “currently active” second malignancy, other than non-melanoma skin cancer, should not be enrolled. Patients are not considered to have a “currently active” malignancy if they have completed therapy for a prior malignancy and are considered by their treating physician to be at less than 30% risk of relapse; Patient is known to be HIV seropositive or who has an AIDS-related illness; Patient has known active hepatitis B or C (and/or treated previously with abnormal liver function tests); Patient has adequate cardiac function by multigated radionucleotide angiography (MUGA) or echocardiography.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1). To evaluate the efficacy of MK-0457, as defined by major cytogenetic response in chronic phase CML and as major hematological response in accelerated phase CML, blastic phase CML, and Ph+-ALL, when given as a 5-day CIV infusion every 14 days. (2) To evaluate the safety of MK-0457 with this dose and regimen.;Secondary Objective: (1). To evaluate the durability of responses with MK-0457. (2). To assess the time to initial hematological response and best hematological response after treatment with MK-0457. (3) To measure the overall hematological response rate in advanced T315I mutant leukemias (i.e. accelerated phase CML, blastic phase CML, and Ph+-ALL), and complete hematological response rate in T315I mutant chronic phase CML. (4). To measure the cytogenetic response rates after treatment with MK-0457.;Primary end point(s): The primary endpoints of this protocol is major cytogenetic response (MCyR) for chronic phase CML patients and major hematological response (MHR) for accelerated phase CML, blastic phase CML, and Ph+-ALL patients. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed