onmyeloablative Hematopoietic Stem Cell Transplantation for Patients with High-Risk Hematologic Malignancies using Related, HLA-Haploidentical Donors: A Phase II Trial of Combined Immunosuppression with cyclophosfamide administered Before and After Transplantation. A monocentric study. - ND

• Conditions: High risk Hematologic Malignancies; MedDRA version: 9.1Level: HLGTClassification code 10024324; MedDRA version: 9.1Level: HLGTClassification code 10025323

• Registration Number: EUCTR2009-018083-94-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-26
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

oPatients =70 years old
oEligible 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 <5% marrow blasts at the time of transplant
-High-risk ALL
-MDS (>int-1 per IPSS) after = 1 prior cycle of induction chemotherapy; should have<5% marrow blasts at the time of transplant
-MM Stage II or III patients who have progressed after an initial response to chemotherapy or autologous HSCT or MM patients with refractory disease who may benefit from tandem autologous-nonmyeloablative allogeneic transplant
-CLL, NHL or HD who are ineligible for autologous HSCT or who have resistant/refractory disease and who may benefit from tandem autologous nonmyeloablative allogeneic transplant.
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

-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:
oLeft ventricular ejection fraction <35%
oDLCO <35% and/or receiving supplemental continuous oxygen
oLiver 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Secondary Objective: ;Primary end point(s): -Donor engraftment at day +84 (efficacy)<br>-Incidence and severity of GVHD (safety) <br>-Non-relapse-related mortality at day +200 (safety)