Clinical trial NCT02553460: Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
Official title: Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
Conditions: Acute Lymphoblastic Leukemia
Summary: The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia cells, but it could also cause additional side effects. Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other cancers in adults, but they have not been approved for treating children with leukemia. With this research, we plan to meet the following goals:
PRIMARY OBJECTIVE:
* Determine the tolerability of incorporating bortezomib and vorinostat into an ALL chemotherapy backbone for newly diagnosed infants with ALL.
SECONDARY OBJECTIVES:
* Estimate the event-free survival and overall survival of infants with ALL who are treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone.
* Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR.
* Compare end of induction, end of consolidation, and end of reinduction MRD levels to Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant outcomes.
Interventions:
description: Given intrathecally (IT).
name: ITMHA
other_name: Intrathecal Triples
Methotrexate/hydrocortisone/cytarabine
type: Drug
description: Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
name: Dexamethasone
other_name: Decadron®
Dexameth®
Dexone®
Hexadrol®
type: Drug
description: Given IV.
name: Mitoxantrone
other_name: Mitozantrone
Novantrone®
type: Drug
description: Given IV. If participant is allergic to pegaspargase, Asparaginase Erwinia Chrysanthemi will be used.
name: Pegaspargase
other_name: Oncaspar®
PEG-asparaginase
type: Drug
description: Asparaginase Erwinia Chrysanthemi will be used in case of allergy or intolerance of participant to PEG-asparaginase. Given IV (preferred) or intramuscularly (IM).
name: Asparaginase Erwinia Chrysanthemi
other_name: Crisantaspase
Erwinase®
Erwinaze^T^M
Erwinia chrysanthemi
type: Drug
description: Given IV.
name: Bortezomib
other_name: LDP-341
MLN341
PS-341
Velcade®
type: Drug
description: Taken PO or NG.
name: Vorinostat
other_name: SAHA
Solinza®
Suberoylanidide Hydroxamic Acid
type: Drug
description: Given IV.
name: Cyclophosphamide
other_name: Cytoxan®
type: Drug
description: Given PO or NG.
name: Mercaptopurine
other_name: 6-MP
Purinethol®
type: Drug
description: Given IV, IM or PO.
name: Methotrexate
other_name: High Dose MTX
MTX
type: Drug
description: Leucovorin rescue PO or IV.
name: Leucovorin Calcium
other_name: Folinic acid
Wellcovorin®
type: Drug
description: Given IV.
name: Cytarabine
other_name: Ara-C
Cytosar-U®
type: Drug
description: Given IV. In case of participant allergy, etoposide phosphate (Etopophos®) will be given.
name: Etoposide
other_name: VP-16
Vepesid®
type: Drug
description: Given IV.
name: Vincristine
other_name: Oncovin®
type: Drug
Study arms:
design_group_description: Participants who meet eligibility requirements will receive remission induction, consolidation treatment, reinduction, reintensification and maintenance therapy.<br/>Interventions: ITMHA, dexamethasone, mitoxantrone, pegaspargase or asparaginase Erwinia chrysanthemi, bortezomib, vorinostat, cyclophosphamide, mercaptopurine, methotrexate, leucovorin calcium, cytarabine, etoposide, and vincristine.
design_group_title: Treatment
design_group_type: Experimental
Sponsor: St. Jude Children's Research Hospital, Inc.
Collaborators: Gateway for Cancer Research
Baylor College of Medicine
Drug name mappings:
name: 伏立诺他
lang: CN
name: Vorinostat
lang: EN
name: ボリノスタット
lang: JP
name: 依托泊苷
lang: CN
name: Etoposide
lang: EN
name: エトポシド
lang: JP
name: 培门冬酶
lang: CN
name: Pegaspargase
lang: EN
name: ペグアスパルガーゼ
lang: JP
name: 巯嘌呤
lang: CN
name: Mercaptopurine
lang: EN
name: メルカプトプリン水和物
lang: JP
name: 硼替佐米
lang: CN
name: Bortezomib
lang: EN
name: ボルテゾミブ
lang: JP
name: 甲氨蝶呤
lang: CN
name: Methotrexate
lang: EN
name: メトトレキサート
lang: JP
name: 阿糖胞苷
lang: CN
name: Cytarabine
lang: EN
name: シタラビン
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: 亚叶酸钙
lang: CN
name: Leucovorin Calcium
lang: EN
name: ホリナートカルシウム
lang: JP
name: 地塞米松磷酸钠
lang: CN
name: Dexamethasone Sodium Phosphate
lang: EN
name: デキサメタゾンリン酸エステルナトリウム
lang: JP
name: 氢化可的松
lang: CN
name: Hydrocortisone
lang: EN
name: ヒドロコルチゾン
lang: JP
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: 硫酸长春新碱
lang: CN
name: Vincristine Sulfate
lang: EN
name: ビンクリスチン硫酸塩
lang: JP