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A Phase II Trial of Extended Induction Epratuzumab (Anti-CD22 Monoclonal Antibody) (CALGB IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase II Trial of Extended Induction Epratuzumab (Anti-CD22 Monoclonal Antibody) (CALGB IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)


OBJECTIVES:

Primary

- To determine the response rate (overall and complete) after extended induction therapy
comprising epratuzumab and rituximab in patients with previously untreated CD20+
follicular non-Hodgkin lymphoma (NHL).

- To determine the time to progression after extended induction therapy comprising
epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL.

Secondary

- To determine the toxicity profile of epratuzumab and rituximab in patients with
previously untreated CD20+ follicular NHL.

- To establish whether the therapeutic effects of the combination of epratuzumab and
rituximab are sufficiently promising to warrant evaluation in a subsequent randomized
trial (in comparison to rituximab alone).

- To determine the relationship between the change in fludeoxyglucose F 18 uptake early
after epratuzumab and rituximab treatment with response rate and time to progression.

OUTLINE:

- Induction therapy (month 1): Patients receive epratuzumab IV over 5-30 minutes on days
1, 8, 15, and 22 and rituximab IV on days 3, 8, 15, and 22 in the absence of disease
progression or unacceptable toxicity.

- Extended induction therapy (months 3, 5, 7, and 9): Patients receive epratuzumab IV
over 5-30 minutes followed by rituximab IV in weeks 12, 20, 28, and 36 in the absence
of disease progression or unacceptable toxicity.

Patients receive fludeoxyglucose F 18 (FDG) subcutaneously and undergo positron emission
tomography at baseline and after induction therapy to assess the degree of FDG uptake.

After completion of study treatment, patients are followed every 4 months for 2 years then
every 6 months for up to 10 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically* confirmed follicular non-Hodgkin lymphoma (NHL)

- Previously untreated disease

- WHO classification grade 1, 2, or 3a (> 15 centroblasts per high power field
with centrocytes present) that is stage III, IV, or bulky (i.e., single mass ≥ 7
cm in any unidimensional measurement) stage II disease NOTE: *Bone marrow
biopsies as the sole means of diagnosis are not acceptable, but they may be
submitted in conjunction with nodal biopsies; fine-needle aspirates are not
acceptable for diagnosis

- Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry

- Measurable disease by physical examination or imaging studies

- Any tumor mass > 1 cm is acceptable

- No nonmeasurable disease only, including any of the following:

- Bone lesions

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Bone marrow (involvement by NHL should be noted)

- No known CNS involvement by lymphoma

- Required to participate in companion FDG-PET imaging study CALGB 580701

PATIENT CHARACTERISTICS:

- ECOG performance status ≤ 2

- Absolute neutrophil count ≥ 1,000/μL

- Platelet count ≥ 50,000/μL

- Patients with HIV infection are eligible provided they meet the following criteria:

- No evidence of coinfection with hepatitis B or C

- CD4+ cell count ≥ 400/mm^3

- No evidence of resistant strains of HIV

- If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV RNA/mL

- If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL

- No history of AIDS-defining conditions

- Not pregnant or nursing

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

- No known Human Anti-Chimeric Antibody (HACA)-positivity

PRIOR CONCURRENT THERAPY:

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

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

- No concurrent dexamethasone or other steroids as antiemetics except for the following
circumstances:

- Treatment of acute infusion reactions according to institutional procedures

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

- No other concurrent chemotherapeutic agents

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

10 months

Safety Issue:

No

Principal Investigator

Barbara W. Grant, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Vermont

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000572604

NCT ID:

NCT00553501

Start Date:

March 2008

Completion Date:

July 2019

Related Keywords:

  • Lymphoma
  • stage II grade 1 follicular lymphoma
  • stage II grade 2 follicular lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
South Bend ClinicSouth Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Kaiser Permanente Medical Office -Vandever Medical OfficeSan Diego, California  92120
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Iredell Memorial HospitalStatesville, North Carolina  28677
Mountainview MedicalBerlin, Vermont  05602
Danville Regional Medical CenterDanville, Virginia  24541
Middlesex Hospital Cancer CenterMiddletown, Connecticut  06457
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Kinston Medical SpecialistsKinston, North Carolina  28501
Lakes Region General HospitalLaconia, New Hampshire  03246
Oncology Care Associates, PLLCSaint Joseph, Michigan  49085
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
St. Mary's Regional Cancer Center at St. Mary's Medical CenterHuntington, West Virginia  25702
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115