Clinical trial NCT02921061: Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDS
Official title: Phase 1/2 Study of Concurrent Decitabine in Combination With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (G-CLAM) in Adults With Newly Diagnosed Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS)
Conditions: Mixed Phenotype Acute Leukemia
Previously Treated Myelodysplastic Syndrome
Recurrent Adult Acute Myeloid Leukemia
Recurrent High Risk Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia
Refractory High Risk Myelodysplastic Syndrome
Untreated Adult Acute Myeloid Leukemia
Summary: This phase I/II trial studies the side effects and best dose of decitabine when given together with filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed, has come back or has not responded to treatment. Drugs used in chemotherapy, such as decitabine, cladribine, cytarabine, and mitoxantrone hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Colony-stimulating factors, such as filgrastim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Decitabine, filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride may work better in treating patients with acute myeloid leukemia and myelodysplastic syndrome.
Interventions:
description: Given IV
name: Cladribine
other_name: 2-CdA
2CDA
CdA
Cladribina
Leustat
Leustatin
Leustatine
RWJ-26251
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 IV
name: Decitabine
other_name: 5-Aza-2'-deoxycytidine
Aza-TdC
Dacogen
Decitabine for Injection
Deoxyazacytidine
Dezocitidine
type: Drug
description: Given SC
name: Filgrastim
other_name: FILGRASTIM, LICENSE HOLDER UNSPECIFIED
G-CSF
Neupogen
Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
Tevagrastim
r-metHuG-CSF
rG-CSF
type: Biological
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Given IV
name: Mitoxantrone Hydrochloride
other_name: CL 232315
DHAD
DHAQ
Dihydroxyanthracenedione Dihydrochloride
Mitoxantrone Dihydrochloride
Mitoxantroni Hydrochloridum
Mitozantrone Hydrochloride
Mitroxone
Neotalem
Novantrone
Onkotrone
Pralifan
type: Drug
Study arms:
design_group_description: INDUCTION: Patients receive decitabine IV over 1 hour on days 1-10. Patients also receive filgrastim SC on days 0-5, cladribine IV over 2 hours on days 1-5, cytarabine IV over 2-4 hours on days 1-5, and mitoxantrone hydrochloride IV over 60 minutes on days 1-3.<br/>RE-INDUCTION: Patients who do not achieve MRDneg CR after first induction are eligible for re-induction. Patients receive the same treatment as during induction except that decitabine is omitted.<br/>CONSOLIDATION THERAPY: Beginning 6 weeks after achieving MRDneg CR or CR/CR with CRi after induction and/or re-induction, patients are eligible to receive filgrastim, cladribine, and cytarabine as in Induction. Treatment may be repeated for up to 4 courses in the absence of disease progression or unacceptable toxicity. Subsequent consolidation cycles would be given after recovery from the previous cycle (roughly 4-6 weeks).
design_group_title: Treatment (decitabine, G-CLAM)
design_group_type: Experimental
Sponsor: Fred Hutchinson Cancer Research Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 克拉屈滨
lang: CN
name: Cladribine
lang: EN
name: クラドリビン
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: 地西他滨
lang: CN
name: Decitabine
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: 阿糖胞苷
lang: CN
name: Cytarabine
lang: EN
name: シタラビン
lang: JP