Clinical trial NCT03440567: Avelumab, Utomilumab, Rituximab, Ibrutinib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma
Official title: A Phase I Study of Avelumab Plus Utomilumab-Based Combination Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Mantle Cell Lymphoma
Conditions: Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory Mantle Cell Lymphoma
Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Summary: This phase I trial studies the side effects and best dose of avelumab, utomilumab, rituximab, ibrutinib, and combination chemotherapy in treating patients with diffuse large B-cell lymphoma or mantle cell lymphoma that has come back or does not respond to treatment. Monoclonal antibodies, such as avelumab, utomilumab, and rituximab, may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide phosphate, carboplatin, and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving avelumab, utomilumab, rituximab, ibrutinib, and combination chemotherapy may work better in treating patients with diffuse large B-cell lymphoma or mantle cell lymphoma.
Interventions:
description: Undergo autologous hematopoietic stem cell transplantation
name: Autologous Hematopoietic Stem Cell Transplantation
other_name: AHSCT
Autologous Hematopoietic Cell Transplantation
Stem Cell Transplantation, Autologous
autologous stem cell transplantation
type: Procedure
description: Given IV
name: Avelumab
other_name: Bavencio
MSB-0010718C
MSB0010718C
type: Drug
description: Given IV
name: Carboplatin
other_name: Blastocarb
CBDCA
Carboplat
Carboplatin Hexal
Carboplatino
Carboplatinum
Carbosin
Carbosol
Carbotec
Displata
Ercar
JM-8
Nealorin
Novoplatinum
Paraplatin
Paraplatin AQ
Paraplatine
Platinwas
Ribocarbo
type: Drug
description: Given IV
name: Etoposide Phosphate
other_name: Etopophos
type: Drug
description: Given PO
name: Ibrutinib
other_name: BTK Inhibitor PCI-32765
CRA-032765
Imbruvica
PCI-32765
type: Drug
description: Given IV
name: Ifosfamide
other_name: Asta Z 4942
Asta Z-4942
Cyfos
Holoxan
Holoxane
IFO
IFO-Cell
IFX
Ifex
Ifolem
Ifomida
Ifomide
Ifosfamidum
Ifoxan
Iphosphamid
Iphosphamide
Iso-Endoxan
Isoendoxan
Isophosphamide
MJF 9325
MJF-9325
Mitoxana
Naxamide
Seromida
Tronoxal
Z 4942
Z-4942
type: Drug
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
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
name: Utomilumab
other_name: PF 05082566
PF 5082566
PF-05082566
PF-2566
type: Biological
Study arms:
design_group_description: Patients receive rituximab IV on day 1, etoposide phosphate IV on days 1-3, avelumab IV over 60 minutes on day 2, ifosfamide IV over 24 hours on day 2, and carboplatin IV on day 2 or rituximab IV on day 1, etoposide phosphate IV on days 1-3, avelumab IV over 60 minutes on days 2, utomilumab IV over 60 minutes on day 2, ifosfamide IV over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may then undergo autologous hematopoietic stem cell transplantation.
design_group_title: Cohort I (avelumab, utomilumab, RICE)
design_group_type: Experimental
design_group_description: Patients receive rituximab IV on day 1, avelumab IV over 60 minutes on days 2 and 16, and ibrutinib PO QD or rituximab IV on day 1, avelumab IV over 60 minutes on days 2 and 16, utomilumab IV on day 2, and ibrutinib PO QD. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. (Closed as of 12/12/2019)
design_group_title: Cohort II (avelumab, utomilumab, rituximab, ibrutinib)
design_group_type: Experimental
Sponsor: City of Hope National Medical Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 伊布替尼
lang: CN
name: Ibrutinib
lang: EN
name: イブルチニブ
lang: JP
name: 阿维单抗
lang: CN
name: Avelumab
lang: EN
name: アベルマブ（遺伝子組換え）
lang: JP
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 磷酸依托泊苷
lang: CN
name: Etoposide Phosphate
lang: EN
name: 异环磷酰胺
lang: CN
name: Ifosamide
lang: EN
name: イホスファミド
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: Utomilumab
lang: EN