RELAPSED/REFRACTORY PEDIATRIC ACUTE EITHER LYMPHOBLASTIC OR MYELOID LEUKEMIA AND SECONDARY ACUTE MYELOID LEUKEMIA. MedDRA version: 14.1 Level: LLT Classification code 10060356 Term: Acute myeloid leukaemia without mention of remission System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10059034 Term: Acute myeloid leukaemia recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and u
Conditions
Interventions
Trade Name: EVOLTRA*4FL 20ML 1MG/ML
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CLOFARABINE
CAS Number: 123318-82-1
Current Sponsor code: NA
Other descriptive name:
Sponsors
AZIENDA SANITARIA OSPEDALIERA O.I.R.M. - S. ANNA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age at diagnosis between 1 and 21 years (20 years and 364 days) - Second or subsequent isolated bone marrow relapses of ALL - Refractory ALL - First or subsequent isolated bone marrow relapses of AML - Either refractory or secondary AML in patients who received previous chemotherapy - Lansky or Karnofsky Performance Status score > 60% - Life expectancy > 6 weeks - Normal Heart function (VEF = 55% 2-D echocardiography) and history negative for concomitant medication to treat cardiopathy -Good organ function defined by: 1) serum creatinine =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Isolated extramedullary relapse of ALL and AML -First isolated bone marrow relapse of ALL -Patients with involvement of central nervous system (CNS) at diagnosis of refractory / relapse of ALL and AML or of secondary AML -Early (<3 months) bone marrow relapse after HSCT (hematopoietic Stem Cell Transplantation) -acute promyelocytic leukemia -Acute leukemia in first or subsequent isolated bone marrow relapse or refractory in patients with Down Syndrome - Current or recent (<30 days) history of either fungal or bacterial infections requiring treatment at diagnosis of either relapsed/refractory ALL/AML or secondary AML -Chemotherapy treatment in the 2 weeks before study entry. Granulocyte growth factor, leukapheresis and cranial irradiation should be discontinued at least 48 hours before the beginning of the protocol - Severe organ dysfunction, especially liver, kidneys, heart and lungs -Other concurrent severe disease that makes it inappropriate to enroll the patient in the study - History of a previous veno-occlusive disease (VOD) -Expected non-compliance to protocol schedule or unable to have regular follow-up due to psychological, social, familial reasons -Hypersensitivity to cytarabine, clofarabine, liposomal daunorubicin -Concomitant administration of any other experimental drug under investigation, or concurrent treatment with any other anti-cancer therapy other than specified in the protocol is not allowed -Pregnant or lactating patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 66 days since the beginning of therapy;Main Objective: EVALUATION OF EFFICACY OF CLOFARABINE IN COMBINATION WITH CYTARABINE AND LIPOSOMAL DOXORUBICIN IN CHILDREN WITH RELAPSED/REFRACTORY ACUTE EITHER LYMPHOBLASTIC OR MYELOID ACUTE LEUKEMIA AND SECONDARY ACUTE MYELOID LEUKEMIA;Secondary Objective: safety and tolerability of clofarabine in combination with cytarabine and liposomal doxorubicin in children with relapsed/refractory acute either lynphoblastic or myeloid acute leukemia and secondary acute myeloid leukemia;Primary end point(s): -Overall Response Rate (ORR) = CR+CRi+PR= Complete Remission+ Complete Remission without either platelets or neutrophils recovery without blasts+ Partial Remission -Complete Remission Rate (CR+Cri) -Partial Remission Rate (RP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)EFS (Event Free Survival), PFS (Progression Free Survival) and OS (Overall Survival) 2)Incidence of adverse grade = 3 events (NCI CTAE version 4.0) excluding nausea and vomit 3)Number of patients who will proceed to HSCT;Timepoint(s) of evaluation of this end point: 1) 12 and 18 months since the beginning of therapy 2)-3) Until HSCT | — |
Countries
Italy
Contacts
Public ContactS.C. ONCOEMATOLOGIA E CENTRO TRAP.
AZIENDA OSPEDALIERA O.I.R.M.-S.ANNA
Outcome results
None listed