Clinical trial NCT03576547: Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
Official title: A Phase I/II Study of the Combination of Venetoclax, Ponatinib and Corticosteroids in Patients With Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia and Lymphoid Blast Phase Chronic Myelogenous Leukemia
Conditions: Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Philadelphia Chromosome Positive
Recurrent Acute Lymphoblastic Leukemia
Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Refractory Acute Lymphoblastic Leukemia
Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
t(9;22)
Summary: This phase I/II trial studies the best dose of venetoclax when given together with ponatinib and dexamethasone and to see how well they work in treating participants with Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukemia or chronic myelogenous leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as venetoclax and dexamethasone, 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. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax, ponatinib, and dexamethasone may work better in treating participants with acute lymphoblastic leukemia or chronic myelogenous leukemia.
Interventions:
description: Given PO or IV
name: Dexamethasone
other_name: Aacidexam
Adexone
Aknichthol Dexa
Alba-Dex
Alin
Alin Depot
Alin Oftalmico
Amplidermis
Anemul mono
Auricularum
Auxiloson
Baycuten
Baycuten N
Cortidexason
Cortisumman
Decacort
Decadrol
Decadron
Decalix
Decameth
Decasone R.p.
Dectancyl
Dekacort
Deltafluorene
Deronil
Desamethasone
Desameton
Dexa-Mamallet
Dexa-Rhinosan
Dexa-Scheroson
Dexa-sine
Dexacortal
Dexacortin
Dexafarma
Dexafluorene
Dexalocal
Dexamecortin
Dexameth
Dexamethasonum
Dexamonozon
Dexapos
Dexinoral
Dexone
Dinormon
Fluorodelta
Fortecortin
Gammacorten
Hexadecadrol
Hexadrol
Lokalison-F
Loverine
Methylfluorprednisolone
Millicorten
Mymethasone
Orgadrone
Spersadex
Visumetazone
type: Drug
description: Given PO
name: Ponatinib Hydrochloride
other_name: AP24534 HCl
Iclusig
type: Drug
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 Biosimilar ABP 798
Rituximab Biosimilar BI 695500
Rituximab Biosimilar CT-P10
Rituximab Biosimilar GB241
Rituximab Biosimilar IBI301
Rituximab Biosimilar PF-05280586
Rituximab Biosimilar RTXM83
Rituximab Biosimilar SAIT101
type: Biological
description: Given PO
name: Venetoclax
other_name: ABT-0199
ABT-199
ABT199
GDC-0199
RG7601
Venclexta
type: Drug
Study arms:
design_group_description: The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
design_group_title: Phase I (400 mg Ponatinib) Treatment (ponatinib, venetoclax, dexamethasone, rituximab)
design_group_type: Experimental
design_group_description: The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
design_group_title: Phase I (800 mg Ponatinib) Treatment (ponatinib, venetoclax, dexamethasone, rituximab)
design_group_type: Experimental
design_group_description: Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
design_group_title: Phase II Ponatinib MDT
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 维奈克拉
lang: CN
name: Venetoclax
lang: EN
name: ベネトクラクス
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: 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
name: 盐酸普纳替尼
lang: CN
name: Ponatinib Hydrochloride
lang: EN
name: ポナチニブ塩酸塩
lang: JP