Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Related, HLA-… (NCT01374841) | Clinical Trial Compass
UnknownPhase 2
Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors
Italy20 participantsStarted 2010-08
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …