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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 InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Elliot Regional Cancer CenterManchester, New Hampshire  03103
CCOP - GreenvilleGreenville, South Carolina  29615
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
CancerCare of Maine at Eastern Maine Medial CenterBangor, Maine  04401
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Lenoir Memorial Cancer CenterKinston, North Carolina  28503-1678
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
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McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
Frisbie Memorial HospitalRochester, New Hampshire  03867
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Community General Hospital of Greater SyracuseSyracuse, New York  13215
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Mountainview MedicalBerlin, Vermont  05602
Danville Regional Medical CenterDanville, Virginia  24541
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Pardee Memorial HospitalHendersonville, North Carolina  28791
McLeod Regional Medical CenterFlorence, South Carolina  29501
Iowa Blood and Cancer CareCedar Rapids, Iowa  52402
St. Mary's Regional Cancer Center at St. Mary's Medical CenterHuntington, West Virginia  25702
CaroMont Cancer Center at Gaston Memorial HospitalGastonia, North Carolina  28053
Capital Region Cancer CenterJefferson City, Missouri  65101
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115