Clinical trial NCT04375631: CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia
Official title: CLAG-M or FLAG-Ida Chemotherapy Followed Immediately by Related/Unrelated Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1 Study
Conditions: Recurrent Acute Myeloid Leukemia
Recurrent Chronic Myelomonocytic Leukemia
Recurrent Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia
Refractory Chronic Myelomonocytic Leukemia
Refractory Mixed Phenotype Acute Leukemia
Refractory Myelodysplastic Syndrome
Refractory Acute Leukemia of Ambiguous Lineage
Refractory Acute Undifferentiated Leukemia
Summary: This phase I trial studies the best dose of total body irradiation when given with cladribine, cytarabine, filgrastim, and mitoxantrone (CLAG-M) or idarubicin, fludarabine, cytarabine and filgrastim (FLAG-Ida) chemotherapy reduced-intensity conditioning regimen before stem cell transplant in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Giving chemotherapy and total body irradiation before a donor peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can attack the body's normal cells called graft versus host disease. Giving cyclophosphamide, cyclosporine, and mycophenolate mofetil after the transplant may stop this from happening.
Interventions:
description: Given IV
name: Cladribine
other_name: 2-CdA
2CDA
CdA
Cladribina
Leustat
Leustatin
Leustatine
RWJ-26251
type: Drug
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 IV then PO
name: Cyclosporine
other_name: 27-400
Ciclosporin
CsA
Cyclosporin
Cyclosporin A
Cyclosporine Modified
Gengraf
Neoral
OL 27-400
Sandimmune
SangCya
type: Drug
description: Given IV
name: Cytarabine
other_name: .beta.-Cytosine arabinoside
1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-.beta.-D-Arabinofuranosylcytosine
1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-Beta-D-arabinofuranosylcytosine
1.beta.-D-Arabinofuranosylcytosine
2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
ARA-cell
Alexan
Ara-C
Arabine
Arabinofuranosylcytosine
Arabinosylcytosine
Aracytidine
Aracytin
Aracytine
Beta-cytosine Arabinoside
CHX-3311
Cytarabinum
Cytarbel
Cytosar
Cytosine Arabinoside
Cytosine-.beta.-arabinoside
Cytosine-beta-arabinoside
Erpalfa
Starasid
Tarabine PFS
U 19920
U-19920
Udicil
WR-28453
type: Drug
description: Given SC
name: Filgrastim
other_name: Filgrastim-aafi
Filgrastim-ayow
G-CSF
Neupogen
Nivestym
Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
Releuko
Tevagrastim
r-metHuG-CSF
rG-CSF
type: Biological
description: Undergo HCT
name: Hematopoietic Cell Transplantation
other_name: HCT
HSCT
Hematopoietic Stem Cell Infusion
Hematopoietic Stem Cell Transplantation
Stem Cell Transplant
stem cell transplantation
type: Procedure
description: Given IV
name: Mitoxantrone
other_name: Dihydroxyanthracenedione
Mitozantrone
type: Drug
description: Given IV or PO
name: Mycophenolate Mofetil
other_name: Cellcept
MMF
type: Drug
description: Given PO
name: Mycophenolate Sodium
other_name: ERL 080
ERL 080A
Socium Mycophenolate
type: Drug
description: Undergo TBI
name: Total-Body Irradiation
other_name: SCT_TBI
TBI
Total Body Irradiation
Whole Body Irradiation
Whole-Body Irradiation
type: Radiation
description: Given IV
name: Idarubicin
other_name: 4-DMDR
type: Drug
description: Given IV
name: Fludarabine
other_name: 9-Beta-D-arabinofuranosyl-2-fluoroadenine
Fluradosa
type: Drug
description: Given IV
name: Cytarabine
other_name: U-19920
Udicil
WR-28453
type: Drug
description: Undergo MUGA
name: Multigated Acquisition Scan
other_name: Blood Pool Scan
Equilibrium Radionuclide Angiography
Gated Blood Pool Imaging
Gated Heart Pool Scan
MUGA
Multi-Gated Acquisition Scan
Radionuclide Ventriculogram Scan
type: Procedure
description: Undergo ECHO
name: Echocardiography Test
other_name: EC
type: Procedure
description: Undergo x-ray
name: X-Ray Imaging
other_name: Conventional X-Ray
Diagnostic Radiology
Medical Imaging
type: Procedure
description: Undergo bone marrow biopsy and aspirate
name: Bone Marrow Biopsy
type: Procedure
description: Undergo bone marrow biopsy and aspirate
name: Bone Marrow Aspiration
type: Procedure
description: Undergo blood sample collection
name: Biospecimen Collection
other_name: Biological Sample Collection
type: Procedure
Study arms:
design_group_description: See detailed description.
design_group_title: Arm I (CLAG-M, TBI, HCT, GVHD prophylaxis)
design_group_type: Experimental
design_group_description: See detailed description.
design_group_title: Arm II (FLAG-Ida, TBI, HCT, GVHD prophylaxis)
design_group_type: Experimental
Sponsor: Fred Hutchinson Cancer Research Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 环孢素
lang: CN
name: Cyclosporine
lang: EN
name: シクロスポリン
lang: JP
name: 克拉屈滨
lang: CN
name: Cladribine
lang: EN
name: クラドリビン
lang: JP
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: 麦考酚钠
lang: CN
name: Mycophenolate Sodium
lang: EN
name: 盐酸米托蒽醌
lang: CN
name: Mitoxantrone Hydrochloride
lang: EN
name: ミトキサントロン塩酸塩
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
name: 阿糖胞苷
lang: CN
name: Cytarabine
lang: EN
name: シタラビン
lang: JP
name: 盐酸伊达比星
lang: CN
name: Idarubicin Hydrochloride
lang: EN
name: イダルビシン塩酸塩
lang: JP