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Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04759586
Recruitment Status : Not yet recruiting
First Posted : February 18, 2021
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

Condition or disease Intervention/treatment Phase
Primary Mediastinal (Thymic) Large B-Cell Lymphoma Drug: Cyclophosphamide Drug: Doxorubicin Hydrochloride Drug: Etoposide Phosphate Biological: Filgrastim Biological: Nivolumab Biological: Pegfilgrastim Drug: Prednisolone Drug: Prednisone Radiation: Radiation Therapy Biological: Rituximab Biological: Rituximab and Hyaluronidase Human Drug: Vincristine Sulfate Phase 3

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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
Estimated Study Start Date : June 15, 2021
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Nivolumab

Arm Intervention/treatment
Active Comparator: Arm A (DA-EPOCH-R)
Patients receive prednisone or prednisolone PO QD on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive etoposide phosphate, doxorubicin hydrochloride, and vincristine sulfate IV over 96 hours on days 1-4 and cyclophosphamide IV over 30-60 minutes on day 5. Beginning 24-72 hours after completing cyclophosphamide, patients receive filgrastim or pegylated filgrastim SC daily until ANC is >= 500/uL after the expected nadir. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • 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

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos

Biological: Filgrastim
Given SC
Other Names:
  • Filgrastim-aafi
  • G-CSF
  • Neupogen
  • Nivestym
  • r-metHuG-CSF
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  • rG-CSF
  • Tevagrastim

Biological: Pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • filgrastim-SD/01
  • Fulphila
  • HSP-130
  • Jinyouli
  • Neulasta
  • Neulastim
  • Nyvepria
  • Pegcyte
  • Pegfilgrastim Biosimilar HSP-130
  • Pegfilgrastim Biosimilar Nyvepria
  • Pegfilgrastim Biosimilar Pegcyte
  • Pegfilgrastim Biosimilar Udenyca
  • Pegfilgrastim Biosimilar Ziextenzo
  • pegfilgrastim-apgf
  • pegfilgrastim-bmez
  • pegfilgrastim-cbqv
  • Pegfilgrastim-jmdb
  • SD-01
  • SD-01 sustained duration G-CSF
  • Udenyca
  • Ziextenzo

Drug: Prednisolone
Given PO
Other Names:
  • (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
  • .delta.1-Hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoid
  • Cortalone
  • Cortisolone
  • Dacortin H
  • Decaprednil
  • Decortin H
  • Delta(1)Hydrocortisone
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolone
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metacortandralone
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafcortelone
  • Precortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prelone
  • Prenilone
  • Sterane

Drug: Prednisone
Given PO
Other Names:
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltasone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Orasone
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisone Intensol
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone

Biological: Rituximab
Given IV
Other Names:
  • ABP 798
  • BI 695500
  • C2B8 Monoclonal Antibody
  • Chimeric Anti-CD20 Antibody
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 Monoclonal Antibody
  • MabThera
  • Monoclonal Antibody IDEC-C2B8
  • PF-05280586
  • 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
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilar TQB2303
  • rituximab-abbs
  • RTXM83
  • Truxima

Biological: Rituximab and Hyaluronidase Human
Given SC
Other Names:
  • Rituxan Hycela
  • Rituximab Plus Hyaluronidase
  • Rituximab/Hyaluronidase
  • Rituximab/Hyaluronidase Human

Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate

Experimental: Arm B (DA-EPOCH-R, nivolumab)
Patients receive treatment as in Arm A. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • 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

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos

Biological: Filgrastim
Given SC
Other Names:
  • Filgrastim-aafi
  • G-CSF
  • Neupogen
  • Nivestym
  • r-metHuG-CSF
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  • rG-CSF
  • Tevagrastim

Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo

Biological: Pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • filgrastim-SD/01
  • Fulphila
  • HSP-130
  • Jinyouli
  • Neulasta
  • Neulastim
  • Nyvepria
  • Pegcyte
  • Pegfilgrastim Biosimilar HSP-130
  • Pegfilgrastim Biosimilar Nyvepria
  • Pegfilgrastim Biosimilar Pegcyte
  • Pegfilgrastim Biosimilar Udenyca
  • Pegfilgrastim Biosimilar Ziextenzo
  • pegfilgrastim-apgf
  • pegfilgrastim-bmez
  • pegfilgrastim-cbqv
  • Pegfilgrastim-jmdb
  • SD-01
  • SD-01 sustained duration G-CSF
  • Udenyca
  • Ziextenzo

Drug: Prednisolone
Given PO
Other Names:
  • (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
  • .delta.1-Hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoid
  • Cortalone
  • Cortisolone
  • Dacortin H
  • Decaprednil
  • Decortin H
  • Delta(1)Hydrocortisone
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolone
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metacortandralone
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafcortelone
  • Precortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prelone
  • Prenilone
  • Sterane

Drug: Prednisone
Given PO
Other Names:
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltasone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Orasone
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisone Intensol
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone

Biological: Rituximab
Given IV
Other Names:
  • ABP 798
  • BI 695500
  • C2B8 Monoclonal Antibody
  • Chimeric Anti-CD20 Antibody
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 Monoclonal Antibody
  • MabThera
  • Monoclonal Antibody IDEC-C2B8
  • PF-05280586
  • 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
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilar TQB2303
  • rituximab-abbs
  • RTXM83
  • Truxima

Biological: Rituximab and Hyaluronidase Human
Given SC
Other Names:
  • Rituxan Hycela
  • Rituximab Plus Hyaluronidase
  • Rituximab/Hyaluronidase
  • Rituximab/Hyaluronidase Human

Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate

Active Comparator: Arm C (R-CHOP)
Patients receive prednisone or prednisolone PO QD on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV over 1-15 minutes or up to 60 minutes, and vincristine sulfate IV over 1 or up to 60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Prednisolone
Given PO
Other Names:
  • (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
  • .delta.1-Hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoid
  • Cortalone
  • Cortisolone
  • Dacortin H
  • Decaprednil
  • Decortin H
  • Delta(1)Hydrocortisone
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolone
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metacortandralone
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafcortelone
  • Precortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prelone
  • Prenilone
  • Sterane

Drug: Prednisone
Given PO
Other Names:
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltasone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Orasone
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisone Intensol
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone

Biological: Rituximab
Given IV
Other Names:
  • ABP 798
  • BI 695500
  • C2B8 Monoclonal Antibody
  • Chimeric Anti-CD20 Antibody
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 Monoclonal Antibody
  • MabThera
  • Monoclonal Antibody IDEC-C2B8
  • PF-05280586
  • 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
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilar TQB2303
  • rituximab-abbs
  • RTXM83
  • Truxima

Biological: Rituximab and Hyaluronidase Human
Given SC
Other Names:
  • Rituxan Hycela
  • Rituximab Plus Hyaluronidase
  • Rituximab/Hyaluronidase
  • Rituximab/Hyaluronidase Human

Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate

Experimental: Arm D (R-CHOP, nivolumab)
Patients receive treatment as in Arm C. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo

Drug: Prednisolone
Given PO
Other Names:
  • (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
  • .delta.1-Hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoid
  • Cortalone
  • Cortisolone
  • Dacortin H
  • Decaprednil
  • Decortin H
  • Delta(1)Hydrocortisone
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolone
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metacortandralone
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafcortelone
  • Precortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prelone
  • Prenilone
  • Sterane

Drug: Prednisone
Given PO
Other Names:
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltasone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Orasone
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisone Intensol
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone

Biological: Rituximab
Given IV
Other Names:
  • ABP 798
  • BI 695500
  • C2B8 Monoclonal Antibody
  • Chimeric Anti-CD20 Antibody
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 Monoclonal Antibody
  • MabThera
  • Monoclonal Antibody IDEC-C2B8
  • PF-05280586
  • 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
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilar TQB2303
  • rituximab-abbs
  • RTXM83
  • Truxima

Biological: Rituximab and Hyaluronidase Human
Given SC
Other Names:
  • Rituxan Hycela
  • Rituximab Plus Hyaluronidase
  • Rituximab/Hyaluronidase
  • Rituximab/Hyaluronidase Human

Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate

Active Comparator: Arm E (R-CHOP, radiation therapy)
Patients receive treatment as in Arm C. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions.
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Drug: Prednisolone
Given PO
Other Names:
  • (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
  • .delta.1-Hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoid
  • Cortalone
  • Cortisolone
  • Dacortin H
  • Decaprednil
  • Decortin H
  • Delta(1)Hydrocortisone
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolone
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metacortandralone
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafcortelone
  • Precortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prelone
  • Prenilone
  • Sterane

Drug: Prednisone
Given PO
Other Names:
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltasone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Orasone
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisone Intensol
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

Biological: Rituximab
Given IV
Other Names:
  • ABP 798
  • BI 695500
  • C2B8 Monoclonal Antibody
  • Chimeric Anti-CD20 Antibody
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 Monoclonal Antibody
  • MabThera
  • Monoclonal Antibody IDEC-C2B8
  • PF-05280586
  • 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
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilar TQB2303
  • rituximab-abbs
  • RTXM83
  • Truxima

Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate

Experimental: Arm F (R-CHOP, nivolumab, radiation therapy)
Patients receive treatment as in Arm D. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions.
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo

Drug: Prednisolone
Given PO
Other Names:
  • (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
  • .delta.1-Hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoid
  • Cortalone
  • Cortisolone
  • Dacortin H
  • Decaprednil
  • Decortin H
  • Delta(1)Hydrocortisone
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolone
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metacortandralone
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafcortelone
  • Precortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prelone
  • Prenilone
  • Sterane

Drug: Prednisone
Given PO
Other Names:
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltasone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Orasone
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisone Intensol
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

Biological: Rituximab
Given IV
Other Names:
  • ABP 798
  • BI 695500
  • C2B8 Monoclonal Antibody
  • Chimeric Anti-CD20 Antibody
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 Monoclonal Antibody
  • MabThera
  • Monoclonal Antibody IDEC-C2B8
  • PF-05280586
  • 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
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilar TQB2303
  • rituximab-abbs
  • RTXM83
  • Truxima

Biological: Rituximab and Hyaluronidase Human
Given SC
Other Names:
  • Rituxan Hycela
  • Rituximab Plus Hyaluronidase
  • Rituximab/Hyaluronidase
  • Rituximab/Hyaluronidase Human




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: From enrollment on the study to first occurrence of relapse/progression or death, assessed up to 5 years ]
    The primary analysis will be a one-sided Log-rank test stratified by choice of backbone and radiation therapy and whether the patient had a cycle of therapy prior to enrolling.


Secondary Outcome Measures :
  1. Efficacy-related event-free survival [ Time Frame: Up to 5 years ]
    Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as progression, change in therapy due to a finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, and death.

  2. Therapy-related event-free survival [ Time Frame: Up to 5 years ]
    Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as progression, change in therapy due to a finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, and death.

  3. Overall survival [ Time Frame: Up to 5 years ]
    Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as only death.

  4. Proportion of positive positron emission tomography (PET) scans [ Time Frame: Up to 6 cycle (1 cycle = 21 days) ]
    Will be analyzed descriptively with a point estimate and Clopper-Pearson 95% confidence interval in the trial overall and in each treatment arm separately. The prognostic significance of positive PET after 6 cycles of therapy will be evaluated using a Cox proportional hazards regression on PFS with PET result (positive versus [vs.] negative), choice of backbone (rituximab [R]-cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] + radiation therapy [RT] regardless of end-of-therapy imaging vs. R-CHOP without RT unless biopsy positive at end-of-therapy vs. dose-adjusted [DA]-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin [EPOCH]-R without RT unless biopsy positive at end of therapy), and assignment to nivolumab (yes vs. no) as covariates.


Other Outcome Measures:
  1. Immune profile of patients treated with nivolumab + chemo-immunotherapy [ Time Frame: Up to 5 years ]
    Analysis will be by paired t-test (for pre- vs. post-treatment measurements) or two-sample equal-variance t-test (for comparisons of nivolumab vs. non-nivolumab or responders [complete response/partial response] vs. non-responders [stable disease/progressive disease]).

  2. Complete response rate [ Time Frame: At the completion of initial planned therapy ]
    Will be described using point estimates and Clopper-Pearson 95% confidence intervals for the complete response rate overall and in each treatment arm separately.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 2 years
  • Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or ECOG performance status of 3 if poor performance is related to lymphoma

    • Children's Oncology Group (COG) Institutions: Use Karnofsky for patients >= 17 and < 18 years of age and Lansky for patients < 17 years of age
  • Adults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
  • Pediatric Patients (age < 18 years): The following must have been obtained within 14 days prior to registration:

    • Measured or calculated (based on institutional standard) creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or
    • Serum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine based on age/gender as follows:

      • Age : 2 to < 6 year; Maximum serum creatinine (mg/dL): 0.8 (male; 0.8 (female)
      • Age : 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 (male); 1 (female)
      • Age : 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female)
      • Age : 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female)
      • Age : >= 16 years to < 18 years; Maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female)
  • Patients with abnormal liver function will be permitted if chemotherapy can still be delivered with standard dose reductions
  • Age >= 18 years: Ejection fraction of >= 50% by echocardiogram
  • Age < 18 years: Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Exclusion Criteria:

  • Administration of prior anti-cancer therapy except as outlined below:

    • A short course (=< 2 weeks) of corticosteroids for the relief of lymphoma-related symptoms
    • A single course of COP (cyclophosphamide, vincristine, and prednisone)
    • One cycle of chemo-immunotherapy including R-CHOP, DA-EPOCH-R, or a pediatric mature B-cell non-Hodgkin lymphoma (B-NHL) induction therapy (such as ANHL1131) that has not started more than 21 days prior to enrollment
  • Active ischemic heart disease or heart failure
  • Active uncontrolled infection
  • Central nervous system (CNS) involvement of lymphoma
  • Previous cancer that required systemic chemotherapy and/or thoracic radiation. Other cancers will be permitted if in remission x 3 years
  • Active autoimmune disease that has required systemic treatment (such as disease modifying agents, corticosteroids, or immunosuppressive agents) in the past 2 years. Replacement therapy such as thyroxine, insulin or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment
  • In patients < 18 years of age hepatitis B serologies consistent with past or current infections
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
  • Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method (failure rate of < 1% per year when used consistently and correctly) for the duration of their study participation
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last dose of rituximab
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759586


Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Lisa G Roth Children's Oncology Group
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04759586    
Other Study ID Numbers: NCI-2021-01071
NCI-2021-01071 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ANHL1931 ( Other Identifier: Children's Oncology Group )
ANHL1931 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: "NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
URL: https://grants.nih.gov/policy/sharing.htm

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Cortisone
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Etoposide
Nivolumab
Vincristine
Etoposide phosphate
Antineoplastic Agents, Immunological
Antibodies