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A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)

Phase 2
18 Years
Open (Enrolling)

Thank you

Trial Information

A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)



- Determine the overall and complete response rate in patients with previously untreated
CD20-positive bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma
treated with rituximab and galiximab.

- Determine the time to disease progression in patients treated with this regimen.


- Determine the toxicity profile of this regimen in these patients.

- Correlate Fc receptor polymorphism profiling with response in patients treated with
this regimen.

OUTLINE: This is a multicenter study.

- Induction therapy (month 1): Patients receive rituximab IV on days 1, 8, 15, and 22 and
galiximab IV over 1 hour on day 3, 8, 15, and 22.

- Extended induction therapy (months 3, 5, 7, and 9): Beginning in month 3, patients
receive rituximab and galiximab as above on day 1. Treatment repeats every 56 days for
4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 4 months for up to 10

PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study within 18 months.

Inclusion Criteria


- Histologically confirmed* previously untreated follicular non-Hodgkin's lymphoma
(NHL), meeting 1 of the following stage criteria:

- Bulky stage II disease (i.e., at least 1 unidimensionally measurable mass ≥ 7

- Stage III or IV disease NOTE: *Bone marrow biopsy as the sole means of diagnosis
is not acceptable; fine needle aspiration is not acceptable

- WHO grade 1, 2, or 3a disease (i.e., > 15 centroblasts per high power field with
centrocytes present)

- CD20-positive disease by flow cytometry or immunohistochemistry

- Measurable disease by physical examination or imaging studies

- Tumor mass > 1 cm

- Patients with only nonmeasurable disease are not eligible

- The following are considered nonmeasurable disease:

- Bone lesions

- Ascites

- Pleural or pericardial effusion

- Lymphangitis cutis or pulmonis

- Bone marrow lesions

- No known CNS involvement by lymphoma



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 50,000/mm^3


- Bilirubin ≤ 2 times upper limit of normal (ULN)* NOTE: *Unless due to lymphoma or
Gilbert's disease


- Creatinine ≤ 2 times ULN* NOTE: *Unless due to lymphoma


- No known HIV positivity

- HIV negative (for patients with a history of IV drug abuse or any behavior
associated with an increased risk for HIV infection)

- No known human anti-chimeric antibody positivity


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment

- No other currently active* malignancy (including Waldenstrom's macroglobulinemia)
except nonmelanoma skin cancer NOTE: *Patients who have completed prior anticancer
therapy AND have < 30% risk for relapse are not considered to have a currently active


Biologic therapy

- No prior immunotherapy (e.g., monoclonal antibody-based therapy) for NHL


- No prior chemotherapy for NHL

- No concurrent chemotherapy

Endocrine therapy

- More than 2 weeks since prior corticosteroids except as maintenance therapy for a
non-malignant disease

- No concurrent hormonal therapy except steroids for adrenal failure OR hormones for
non-disease-related conditions (e.g., insulin for diabetes)

- No concurrent dexamethasone or other steroidal antiemetics except for the following

- Acute grade 3 or 4 monoclonal antibody-associated infusion reaction not
responsive to transient discontinuation of antibody infusion or acetaminophen
and diphenhydramine

- Retreatment after an infusion reaction


- No prior radiotherapy for NHL


- Not specified

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response

Outcome Description:

complete and partial response will be assessed

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Myron S. Czuczman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

March 2017

Related Keywords:

  • Lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Chicago Cancer Research Center Chicago, Illinois  60637
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
Methodist Medical Center of Illinois Peoria, Illinois  61636
Elliot Regional Cancer Center Manchester, New Hampshire  03103
CCOP - Greenville Greenville, South Carolina  29615
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Long Island Jewish Medical Center New Hyde Park, New York  11040
CancerCare of Maine at Eastern Maine Medial Center Bangor, Maine  04401
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
New Hampshire Oncology-Hematology, PA - Hooksett Hooksett, New Hampshire  03106
Memorial Cancer Institute at Memorial Regional Hospital Hollywood, Florida  33021
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Lenoir Memorial Cancer Center Kinston, North Carolina  28503-1678
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale, Florida  33308
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter, Florida  33458
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana  46815
St. Luke's Hospital Cedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids, Iowa  52403
Kingsbury Center for Cancer Care at Cheshire Medical Center Keene, New Hampshire  03431
Frisbie Memorial Hospital Rochester, New Hampshire  03867
Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls, New York  12801
Community General Hospital of Greater Syracuse Syracuse, New York  13215
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wilson Medical Center Wilson, North Carolina  27893-3428
Bon Secours St. Francis Health System Greenville, South Carolina  29601
Mountainview Medical Berlin, Vermont  05602
Danville Regional Medical Center Danville, Virginia  24541
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224-1791
Pardee Memorial Hospital Hendersonville, North Carolina  28791
McLeod Regional Medical Center Florence, South Carolina  29501
Iowa Blood and Cancer Care Cedar Rapids, Iowa  52402
St. Mary's Regional Cancer Center at St. Mary's Medical Center Huntington, West Virginia  25702
CaroMont Cancer Center at Gaston Memorial Hospital Gastonia, North Carolina  28053
Capital Region Cancer Center Jefferson City, Missouri  65101
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County Martinsville, Virginia  24115