Clinical trial NCT02446964: Total Marrow and Lymphoid Irradiation and Chemotherapy Before Donor Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Leukemia
Official title: Phase I Study of Escalating Doses of Total Marrow and Lymphoid Irradiation (TMLI) During Conditioning for HLA-Haploidentical Hematopoietic Cell Transplantation With Post-Transplant Cyclophosphamide in Patients With Myelodysplasia or Acute Leukemia
Conditions: Adult Acute Lymphoblastic Leukemia in Complete Remission
Acute Myeloid Leukemia in Remission
Previously Treated Myelodysplastic Syndrome
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Childhood Acute Lymphoblastic Leukemia in Complete Remission
Summary: This phase I trial studies the side effects and best dose of total bone marrow and lymphoid irradiation when given together with chemotherapy before donor stem cell transplant in treating patients with myelodysplastic syndrome or acute leukemia. Total marrow and lymphoid irradiation is a type of radiation therapy that targets bone marrow and blood, where the cancer is, instead of applying radiation to the whole body. Stem cell transplants use high doses of chemotherapy and radiation therapy, such as total marrow and lymphoid irradiation, to kill cancer cells, but these treatments kill normal cells as well. After chemotherapy, healthy cells from a donor are given to the patient to help the patient grow new blood cells.
Interventions:
description: Undergo bone marrow transplant
name: Bone Marrow Transplantation
other_name: BMT
Bone Marrow Grafting
Bone Marrow Transplant
Marrow Transplantation
type: Procedure
description: Given IV
name: Cyclophosphamide
other_name: (-)-Cyclophosphamide
2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
CP monohydrate
CTX
CYCLO-cell
Carloxan
Ciclofosfamida
Ciclofosfamide
Cicloxal
Clafen
Claphene
Cycloblastin
Cycloblastine
Cyclophospham
Cyclophosphamid monohydrate
Cyclophosphamidum
Cyclophosphan
Cyclophosphane
Cyclophosphanum
Cyclostin
Cyclostine
Cytophosphan
Cytophosphane
Cytoxan
Fosfaseron
Genoxal
Genuxal
Ledoxina
Mitoxan
Neosar
Revimmune
Syklofosfamid
WR- 138719
type: Drug
description: Given IV
name: Fludarabine Phosphate
other_name: 2-F-ara-AMP
9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-
Beneflur
Fludara
Oforta
SH T 586
type: Drug
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Given PO or IV
name: Mycophenolate Mofetil
other_name: Cellcept
MMF
type: Drug
description: Undergo peripheral blood stem cell transplant
name: Peripheral Blood Stem Cell Transplantation
other_name: PBPC transplantation
Peripheral Blood Progenitor Cell Transplantation
Peripheral Stem Cell Support
Peripheral Stem Cell Transplantation
type: Procedure
description: Given IV and PO
name: Tacrolimus
other_name: FK 506
Fujimycin
Prograf
Protopic
type: Drug
description: Undergo TMLI
name: Total Marrow Irradiation
type: Radiation
Study arms:
design_group_description: CONDITIONING: Patients undergo TMLI BID on days -7 to -4 or -3 (depending on the dose level). Patients also receive fludarabine phosphate IV on days -7 to -3 and cyclophosphamide IV on days -7, -6, 3, and 4.<br/>TRANSPLANT: Patients undergo bone marrow or peripheral blood stem cell transplant on day 0.<br/>GHVD PROPHYLAXIS: Patients receive tacrolimus* IV QD or PO BID on days 5-180. Patients also receive mycophenolate mofetil PO TID or IV on days 5-35. Treatment with tacrolimus and mycophenolate mofetil may continue in the presence of active GVHD.<br/>*NOTE: Patients intolerant of tacrolimus may receive cyclosporine.
design_group_title: Treatment (TMLI, chemotherapy, transplant, GVHD prophylaxis)
design_group_type: Experimental
Sponsor: City of Hope National Medical Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 他克莫司
lang: CN
name: Tacrolimus
lang: EN
name: タクロリムス水和物
lang: JP
name: 吗替麦考酚酯
lang: CN
name: Mycophenolate Mofetil
lang: EN
name: ミコフェノール酸 モフェチル
lang: JP