Clinical trial NCT02960646: Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Official title: Phase I Clinical Trial Using an Engineered Peripheral Blood Graft for Haploidentical Transplantation
Conditions: Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Aplastic Anemia
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Chronic Myelomonocytic Leukemia
Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Lymphoblastic Lymphoma
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Plasma Cell Myeloma
Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Recurrent Hodgkin Lymphoma
Recurrent Non-Hodgkin Lymphoma
Recurrent Plasma Cell Myeloma
Therapy-Related Myelodysplastic Syndrome
Summary: This pilot phase I trial studies the side effects of engineered donor stem cell transplant in treating patients with hematologic malignancies. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Using T cells specially selected from donor blood in the laboratory for transplant may stop this from happening.
Interventions:
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
Cyclophosphamide Monohydrate
Cyclophosphamidum
Cyclophosphan
Cyclophosphane
Cyclophosphanum
Cyclostin
Cyclostine
Cytophosphan
Cytophosphane
Cytoxan
Fosfaseron
Genoxal
Genuxal
Ledoxina
Mitoxan
Neosar
Revimmune
Syklofosfamid
WR- 138719
type: Drug
description: Given SC
name: Filgrastim
other_name: G-CSF
Neupogen
Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
Tevagrastim
r-metHuG-CSF
rG-CSF
type: Biological
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: Melphalan
other_name: Alanine Nitrogen Mustard
CB-3025
L-PAM
L-Phenylalanine Mustard
L-Sarcolysin
L-Sarcolysin Phenylalanine mustard
L-Sarcolysine
Melphalanum
Phenylalanine Mustard
Phenylalanine Nitrogen Mustard
Sarcoclorin
Sarkolysin
WR-19813
type: Drug
description: Undergo CD45RA depleted peripheral blood stem cell transplantation
name: Peripheral Blood Stem Cell Transplantation
other_name: PBPC transplantation
PBSCT
Peripheral Blood Progenitor Cell Transplantation
Peripheral Stem Cell Support
Peripheral Stem Cell Transplant
Peripheral Stem Cell Transplantation
type: Procedure
description: Given IV
name: Rituximab
other_name: ABP 798
BI 695500
C2B8 Monoclonal Antibody
CT-P10
Chimeric Anti-CD20 Antibody
IDEC-102
IDEC-C2B8
IDEC-C2B8 Monoclonal Antibody
MabThera
Monoclonal Antibody IDEC-C2B8
PF-05280586
RTXM83
Rituxan
Rituximab ABBS
Rituximab Biosimilar ABP 798
Rituximab Biosimilar BI 695500
Rituximab Biosimilar CT-P10
Rituximab Biosimilar GB241
Rituximab Biosimilar IBI301
Rituximab Biosimilar JHL1101
Rituximab Biosimilar PF-05280586
Rituximab Biosimilar RTXM83
Rituximab Biosimilar SAIT101
Truxima
rituximab biosimilar TQB2303
rituximab-abbs
type: Biological
description: Given IV or PO
name: Tacrolimus
other_name: FK 506
Fujimycin
Hecoria
Prograf
Protopic
type: Drug
description: Undergo TBI
name: Total-Body Irradiation
other_name: TBI
Total Body Irradiation
Whole Body Irradiation
Whole-Body Irradiation
type: Radiation
Study arms:
design_group_description: Patients receive melphalan IV over 30 minutes on day -6 and fludarabine phosphate IV over 1 hour on days -6 to -3. Patients undergo TBI on day -2 and CD45RA depleted peripheral blood stem cell transplantation on day 0. Patients also receive cyclophosphamide IV over 3 hours on days 3-4. Beginning on day 5, patients receive tacrolimus IV for 2 weeks and PO for at least 4 months. Beginning on day 7, patients receive filgrastim SC daily. Patients with CD20 positive lymphoma may receive rituximab IV on days -13, -6, 1, and 8.
design_group_title: Treatment (peripheral blood stem cell transplantation)
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer 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: 非格司亭 （安进）
lang: CN
name: Filgrastim (Amgen)
lang: EN
name: フィルグラスチム（遺伝子組換え）
lang: JP
name: 美法仑
lang: CN
name: Melphalan
lang: EN
name: メルファラン
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: 利妥昔单抗
lang: CN
name: Rituximab
lang: EN
name: リツキシマブ（遺伝子組換え）
lang: JP