Recruitment

Recruitment Status
Recruiting

Inclusion Criteria

AML ≥ CR2; patients should have <5% marrow blasts at the time of transplant
Eligible diagnoses:
Patients ≤70 years old
...
AML ≥ CR2; patients should have <5% marrow blasts at the time of transplant
Eligible diagnoses:
Patients ≤70 years old
High-risk ALL defined as:
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

Exclusion Criteria

Fertile men and women unwilling to use contraceptives during and for 12 months post transplant
Left ventricular ejection fraction <35%
CNS involvement with disease refractory to intrathecal chemotherapy
...
Fertile men and women unwilling to use contraceptives during and for 12 months post transplant
Left ventricular ejection fraction <35%
CNS involvement with disease refractory to intrathecal chemotherapy
HIV-positive patients
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)
Women of childbearing potential who are pregnant (β-HCG+) or breast feeding
Patients with suitably matched related or unrelated donors
Presence of active, serious infection (e.g., mucormycosis, uncontrolled aspergillosis, tuberculosis)
Life expectancy severely limited by diseases other than malignancy
Karnofsky Performance Status < 60% for adult patients (Appendix A)
Patients on any other investigational drug at time of enrolment
Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL or symptomatic biliary disease.
DLCO <35% and/or receiving supplemental continuous oxygen

Summary

Conditions
Hematologic Neoplasms
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

It is important to extend the option of nonmyeloablative, hematopoietic stem cell transplantation (HSCT) for potential therapy of hematologic malignancies to patients who do not have an HLA-matched donor. Almost all patients would have a related donor identical for one HLA haplotype (haploidentical)...

It is important to extend the option of nonmyeloablative, hematopoietic stem cell transplantation (HSCT) for potential therapy of hematologic malignancies to patients who do not have an HLA-matched donor. Almost all patients would have a related donor identical for one HLA haplotype (haploidentical) and mismatched at HLA-A, B or DR of the unshared haplotype. Thus far, nonmyeloablative HSCT from HLA-mismatched donors has been associated with a high rate of graft failure and graft-versus-host disease (GVHD). In this protocol, we will use a combination of immunosuppressive agents including cyclophosphamide administered before and after HSCT to facilitate engraftment and to delete highly alloreactive T-cell clones presumably involved in GVHD.

Inclusion Criteria

AML ≥ CR2; patients should have <5% marrow blasts at the time of transplant
Eligible diagnoses:
Patients ≤70 years old
...
AML ≥ CR2; patients should have <5% marrow blasts at the time of transplant
Eligible diagnoses:
Patients ≤70 years old
High-risk ALL defined as:
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

Exclusion Criteria

Fertile men and women unwilling to use contraceptives during and for 12 months post transplant
Left ventricular ejection fraction <35%
CNS involvement with disease refractory to intrathecal chemotherapy
...
Fertile men and women unwilling to use contraceptives during and for 12 months post transplant
Left ventricular ejection fraction <35%
CNS involvement with disease refractory to intrathecal chemotherapy
HIV-positive patients
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)
Women of childbearing potential who are pregnant (β-HCG+) or breast feeding
Patients with suitably matched related or unrelated donors
Presence of active, serious infection (e.g., mucormycosis, uncontrolled aspergillosis, tuberculosis)
Life expectancy severely limited by diseases other than malignancy
Karnofsky Performance Status < 60% for adult patients (Appendix A)
Patients on any other investigational drug at time of enrolment
Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL or symptomatic biliary disease.
DLCO <35% and/or receiving supplemental continuous oxygen

Tracking Information

NCT #
NCT01374841
Collaborators
Not Provided
Investigators
  • Principal Investigator: Rocco Pastano, MD European Institute of Oncology
  • Rocco Pastano, MD European Institute of Oncology
About Us
Innovation
Privacy
Terms
Copyright
Get Well Soon © Copyright 2024