Brief Summary
This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.
Brief Title
Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
Detailed Description
In Part A of the study, patients will be randomized 1:1 to receive denintuzumab mafodotin plus RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or denintuzumab mafodotin plus RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) to assess the safety of these 2 combination regimens. Part B of the study is designed to evaluate the antitumor activity and safety of denintuzumab mafodotin in combination with either RCHOP or RCHP (Experimental Arm) compared with RCHOP alone (Comparator Arm).
Completion Date
Completion Date Type
Actual
Conditions
Diffuse, Large B-Cell, Lymphoma
Follicular Lymphoma, Grade 3b
Transformed Lymphoma / DLBCL
Eligibility Criteria
Inclusion Criteria:
* Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b;
* patients must have high intermediate or high risk disease
* Tumor tissue available from most recent biopsy to determine cell of origin
* Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter
* Eastern Cooperative Oncology Group performance status ≤2
* Age 18 years or older
* Adequate study baseline laboratory parameters
Exclusion Criteria:
* Previous history of treated indolent lymphoma
* History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
* History of progressive multifocal leukoencephalopathy
* Cerebral/meningeal disease related to the underlying malignancy
* Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment
* Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b;
* patients must have high intermediate or high risk disease
* Tumor tissue available from most recent biopsy to determine cell of origin
* Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter
* Eastern Cooperative Oncology Group performance status ≤2
* Age 18 years or older
* Adequate study baseline laboratory parameters
Exclusion Criteria:
* Previous history of treated indolent lymphoma
* History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
* History of progressive multifocal leukoencephalopathy
* Cerebral/meningeal disease related to the underlying malignancy
* Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment
Inclusion Criteria
Inclusion Criteria:
* Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b;
* patients must have high intermediate or high risk disease
* Tumor tissue available from most recent biopsy to determine cell of origin
* Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter
* Eastern Cooperative Oncology Group performance status ≤2
* Age 18 years or older
* Adequate study baseline laboratory parameters
* Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b;
* patients must have high intermediate or high risk disease
* Tumor tissue available from most recent biopsy to determine cell of origin
* Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter
* Eastern Cooperative Oncology Group performance status ≤2
* Age 18 years or older
* Adequate study baseline laboratory parameters
Gender
All
Gender Based
false
Keywords
Antibodies, Monoclonal
SGN-19A
Denintuzumab Mafodotin
DLBCL
Antibody-Drug Conjugate
Antigens, CD19
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Immunotherapy
Lymphatic Diseases
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Monomethyl auristatin F
Neoplasms
Neoplasms by Histologic Type
Transformed Lymphoma / DLBCL
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotic, Antineoplastic
Antimitotic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Phytogenic Antirheumatic Agents
Glucocorticoids
Drug Therapy
Follicular Lymphoma Grade 3b
immunosuppressive agents
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02855359
Org Class
Industry
Org Full Name
Seagen Inc.
Org Study Id
SGN19A-004
Overall Status
Terminated
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alone as Frontline Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Grade 3b
Primary Outcomes
Outcome Description
Study did not progress to Part B.
Outcome Measure
Part B Outcome Measure: Complete Response Rate (CR)
Outcome Time Frame
N/A - Endpoint not assessed
Outcome Description
Part A data only; study did not progress to Part B.
Outcome Measure
Part A and Part B Outcome Measure: Incidence of Adverse Events
Outcome Time Frame
54.7 weeks
Outcome Description
Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported.
Outcome Measure
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Outcome Time Frame
Up to 183 days
Secondary Outcomes
Outcome Description
Study did not progress to Part B
Outcome Time Frame
N/A - Endpoint not assessed
Outcome Measure
Event-free Survival (EFS) Between Study Arms in Part B
Outcome Description
Study did not progress to Part B.
Outcome Time Frame
N/A - Endpoint not assessed
Outcome Measure
Progression-free Survival (PFS) Between Study Arms in Part B
Outcome Description
Study did not progress to Part B.
Outcome Time Frame
N/A - Endpoint not assessed
Outcome Measure
Overall Survival (OS) Between Study Arms in Part B
Outcome Description
Study did not progress to Part B.
Outcome Time Frame
N/A - Endpoint not assessed
Outcome Measure
Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B
Outcome Description
Study did not progress to Part B.
Outcome Time Frame
N/A - Endpoint not assessed
Outcome Measure
Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Murali Janakiram
Investigator Email
mjanakir@montefiore.org
Investigator Phone
718-430-4154
Categories Mesh Debug
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- LYMPHATIC DISEASES
Cancer --- NEOPLASMS
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
MeSH Terms
LYMPHOMA, LARGE B-CELL, DIFFUSE
LYMPHOMA, FOLLICULAR
HEMATOLOGIC DISEASES
IMMUNE SYSTEM DISEASES
IMMUNOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
LYMPHOMA
LYMPHOMA, B-CELL
LYMPHOMA, NON-HODGKIN
NEOPLASMS
NEOPLASMS BY HISTOLOGIC TYPE
LYMPHOPROLIFERATIVE DISORDERS
HEMIC AND LYMPHATIC DISEASES
RITUXIMAB
CYCLOPHOSPHAMIDE
DOXORUBICIN
VINCRISTINE
PREDNISONE
ANTIBODIES, MONOCLONAL, MURINE-DERIVED
ANTIBODIES, MONOCLONAL
ANTIBODIES
IMMUNOGLOBULINS
IMMUNOPROTEINS
BLOOD PROTEINS
PROTEINS
AMINO ACIDS, PEPTIDES, AND PROTEINS
SERUM GLOBULINS
GLOBULINS
PHOSPHORAMIDE MUSTARDS
NITROGEN MUSTARD COMPOUNDS
MUSTARD COMPOUNDS
HYDROCARBONS, HALOGENATED
HYDROCARBONS
ORGANIC CHEMICALS
PHOSPHORAMIDES
ORGANOPHOSPHORUS COMPOUNDS
DAUNORUBICIN
ANTHRACYCLINES
NAPHTHACENES
POLYCYCLIC AROMATIC HYDROCARBONS
HYDROCARBONS, AROMATIC
HYDROCARBONS, CYCLIC
POLYCYCLIC COMPOUNDS
AMINOGLYCOSIDES
GLYCOSIDES
CARBOHYDRATES
VINCA ALKALOIDS
SECOLOGANIN TRYPTAMINE ALKALOIDS
INDOLE ALKALOIDS
ALKALOIDS
HETEROCYCLIC COMPOUNDS
INDOLES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
INDOLIZIDINES
INDOLIZINES
PREGNADIENEDIOLS
PREGNADIENES
PREGNANES
STEROIDS
FUSED-RING COMPOUNDS