High risk Hematologic Malignancies MedDRA version: 9.1 Level: HLGT Classification code 10024324 MedDRA version: 9.1 Level: HLGT Classification code 10025323
Conditions
Interventions
Trade Name: ENDOXAN BAXTER*INIET 10FL200MG
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Cyclophosphamide
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Patients =70 years old o Eligible diagnoses: - CML in AP - AML with high-risk cytogenetics [del(5q)/-5, del(7q)/-7, abnormal 3q, 9q, 11q, 20q, 21q, 17p, t(6:9), t(9;22), complex karyotypes (=3 abnormalities)] in CR1 - AML = CR2; patients should have int-1 per IPSS) after = 1 prior cycle of induction chemotherapy; should have=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Cross-match positive with donor - Patients with suitably matched related or unrelated donors - Patients with conventional transplant options (a conventional transplant should be the priority for eligible patients = 50 yr of age who have a related donor mismatched for a single HLA-A, -B or DRB1 antigen) - Presence of active, serious infection (e.g., mucormycosis, uncontrolled aspergillosis, - tuberculosis) - Patients with the following organ dysfunction: o Left ventricular ejection fraction <35% o DLCO <35% and/or receiving supplemental continuous oxygen o Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of - HIV-positive patients - Women of childbearing potential who are pregnant (ß-HCG+) or breast feeding - Fertile men and women unwilling to use contraceptives during and for 12 mo posttransplant - Life expectancy severely limited by diseases other than malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): -Donor engraftment at day +84 (efficacy) -Incidence and severity of GVHD (safety) -Non-relapse-related mortality at day +200 (safety);Main Objective: To determine if engraftment can be achieved safely in patients with high-risk hematologic malignancies who undergo non-myeloablative transplant with peripheral stem cells from HLA-haploidentical donors. | — |
Countries
Italy
Outcome results
None listed