Clinical trial NCT01640301: Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant
Official title: Phase I/II Study of Adoptive Immunotherapy After Allogeneic HCT With Virus Specific CD8+ T Cells That Have Been Transduced to Express a WT1-Specific T Cell Receptor for Patients With Relapsed AML
Conditions: Recurrent Adult Acute Myeloid Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Therapy-Related Acute Myeloid Leukemia
Donor
Hematopoietic Cell Transplant Recipient
HLA-A*0201 Positive Cells Present
Recurrent Acute Myeloid Leukemia
Summary: This phase I/II trial studies the side effects of laboratory-treated T cells and to see how well they work in treating patients with high-risk acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelogenous leukemia (CML) that has returned after a period of improvement (relapsed), previously treated with donor stem cell transplant. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop cancer cells from growing. Placing a gene that has been created in the laboratory into a person's T cells may make the body build an immune response to kill cancer cells.
Interventions:
description: Given SC
name: Aldesleukin
other_name: 125-L-Serine-2-133-interleukin 2
Proleukin
Recombinant Human IL-2
Recombinant Human Interleukin-2
r-serHuIL-2
type: Biological
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
SH T 586
type: Drug
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Given IV
name: WT1-Sensitized Allogeneic T-Lymphocytes
type: Biological
Study arms:
design_group_description: Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28.
design_group_title: Arm I (high-risk for relapse after HCT)
design_group_type: Experimental
design_group_description: Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28.
design_group_title: Arm II (relapsed after HCT)
design_group_type: Experimental
Sponsor: Fred Hutchinson Cancer Research Center
Collaborators: National Cancer Institute
Drug name mappings:
name: WT1-Sensitized Allogeneic T-Lymphocytes(NCI)
lang: EN
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: 阿地白介素
lang: CN
name: Aldesleukin
lang: EN