Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

NCT02855359 | Terminated Phase 2 Results

• 1 other identifier: SGN19A-004
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 35

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.

Conditions

Diffuse, Large B-Cell, Lymphoma; Follicular Lymphoma, Grade 3b; Transformed Lymphoma / DLBCL

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

Outcome Measures

Primary Outcomes (3)

• Part B Outcome Measure: Complete Response Rate (CR)

  Study did not progress to Part B.

  N/A - Endpoint not assessed

• Part A and Part B Outcome Measure: Incidence of Adverse Events

  Part A data only; study did not progress to Part B.

  54.7 weeks

• Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities

  Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported.

  Up to 183 days

Secondary Outcomes (5)

• Event-free Survival (EFS) Between Study Arms in Part B

  N/A - Endpoint not assessed

• Progression-free Survival (PFS) Between Study Arms in Part B

  N/A - Endpoint not assessed

• Overall Survival (OS) Between Study Arms in Part B

  N/A - Endpoint not assessed

• Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B

  N/A - Endpoint not assessed

• Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B

  N/A - Endpoint not assessed

Study Arms (4)

denintuzumab mafodotin + RCHOP

EXPERIMENTAL

Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)

Drug: denintuzumab mafodotin; Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: vincristine; Drug: prednisone

denintuzumab mafodotin + RCHP

EXPERIMENTAL

Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)

Drug: denintuzumab mafodotin; Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: prednisone

denintuzumab mafodotin + RCHOP or RCHP

EXPERIMENTAL

Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP

Drug: denintuzumab mafodotin; Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: vincristine; Drug: prednisone

RCHOP

ACTIVE COMPARATOR

Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)

Drug: rituximab; Drug: cyclophosphamide; Drug: doxorubicin; Drug: vincristine; Drug: prednisone

Interventions

denintuzumab mafodotin DRUG

SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles

denintuzumab mafodotin + RCHOP; denintuzumab mafodotin + RCHOP or RCHP; denintuzumab mafodotin + RCHP

rituximab DRUG

375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

RCHOP; denintuzumab mafodotin + RCHOP; denintuzumab mafodotin + RCHOP or RCHP; denintuzumab mafodotin + RCHP

cyclophosphamide DRUG

750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

RCHOP; denintuzumab mafodotin + RCHOP; denintuzumab mafodotin + RCHOP or RCHP; denintuzumab mafodotin + RCHP

doxorubicin DRUG

50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

RCHOP; denintuzumab mafodotin + RCHOP; denintuzumab mafodotin + RCHOP or RCHP; denintuzumab mafodotin + RCHP

vincristine DRUG

1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)

RCHOP; denintuzumab mafodotin + RCHOP; denintuzumab mafodotin + RCHOP or RCHP

prednisone DRUG

100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles

RCHOP; denintuzumab mafodotin + RCHOP; denintuzumab mafodotin + RCHOP or RCHP; denintuzumab mafodotin + RCHP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (35)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Saint Bernards Cancer Center

Jonesboro, Arkansas, 72401, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Compassionate Cancer Care Medical Group, Inc.

Fountain Valley, California, 92708, United States

Location

Pacific Hematology Oncology Associates

San Francisco, California, 94115, United States

Location

University of Colorado Health Memorial Hospital

Colorado Springs, Colorado, 80909, United States

Location

Poudre Valley Hospital Harmony Campus

Fort Collins, Colorado, 80528, United States

Location

Central Georgia Cancer Care

Macon, Georgia, 31201, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Montgomery Cancer Center

Mount Sterling, Kentucky, 40353, United States

Location

Tulane University Hospital and Clinic

New Orleans, Louisiana, 70122, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

Hattiesburg Clinic (Forrest General Hospital)

Hattiesburg, Mississippi, 39401, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Montefiore Medical Center - Bronx

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Regional Medical Oncology Center

Wilson, North Carolina, 27893, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Tennessee Oncology / Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Baylor Health - Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410, United States

Location

Scott and White Memorial Hospital - Temple

Temple, Texas, 76508, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Vista Oncology INC PS

Olympia, Washington, 98502, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

Ponce Medical School Foundation

Ponce, 00716, Puerto Rico

Location

MeSH Terms

Conditions

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

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Study was ended by sponsor prior to Part B enrollment.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Seattle Genetics, Inc.

medinfo@seagen.com

855-473-2436

Study Officials

• Juan Pinelli, PA-C, MMSc.

  Seagen Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 4, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: May 15, 2018
• Last Updated: March 11, 2019
• Results First Posted: January 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (34)