Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Related HLA-Haploidentical Donors

  • STATUS
    Recruiting
  • End date
    Dec 7, 2022
  • participants needed
    20
  • sponsor
    European Institute of Oncology
Updated on 7 October 2021
cancer
immunosuppressant
graft versus host disease
cyclophosphamide
cell transplantation

Summary

The purpose of this study is 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 Human Leukocyte Antigen (HLA) haploidentical donors with pre and post-transplant cyclophosphamide as immunosuppression.

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) 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.

Details
Condition Hematologic Malignancy, Blood Cancer, Hematologic Neoplasms, hematologic malignancies, hematological tumor, Hematological Disorders, Hematologic Cancer, hematological malignancies, haematological malignancy, Blood disorder, hematological malignancy
Treatment cyclophosphamide, Hematopoietic Stem Cell Transplantation,
Clinical Study IdentifierNCT01374841
SponsorEuropean Institute of Oncology
Last Modified on7 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients 70 years old
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 <5% marrow blasts at the time of transplant
High-risk ALL defined as
CR1 with high-risk cytogenetics t(9;22), t(8;14), t(4;11), t(1;19) for adult
patients >4 wk to achieve CR1
CR2 Patients should have <5% marrow blasts at the time of transplant
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
Patients who have received a prior allogeneic HSCT and who have either rejected their grafts or who have become tolerant of their grafts with no active GvHD requiring immunosuppressive therapy could be enrolled

Exclusion Criteria

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)
CNS involvement with disease refractory to intrathecal chemotherapy
Presence of active, serious infection (e.g., mucormycosis, uncontrolled aspergillosis, tuberculosis)
Karnofsky Performance Status < 60% for adult patients (Appendix A)
Patients with the following organ dysfunction
Left ventricular ejection fraction <35%
DLCO <35% and/or receiving supplemental continuous oxygen
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
HIV-positive patients
Women of childbearing potential who are pregnant (-HCG+) or breast feeding
Fertile men and women unwilling to use contraceptives during and for 12 months post transplant
Life expectancy severely limited by diseases other than malignancy
Patients on any other investigational drug at time of enrolment
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