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Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00553501
  Purpose

RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin lymphoma.

PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.


Condition Intervention Phase
Lymphoma
Drug: epratuzumab
Drug: fludeoxyglucose F 18
Drug: rituximab
Phase II

MedlinePlus related topics:   Cancer    Lymphoma   

ChemIDplus related topics:   Rituximab    Fluorodeoxyglucose F18    Epratuzumab    Yttrium Y 90 Epratuzumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   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)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate (complete or partial) at 12 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Time to progression (TTP) [ Designated as safety issue: No ]
  • Time to best response [ Designated as safety issue: No ]

Estimated Enrollment:   58
Study Start Date:   March 2008
Estimated Primary Completion Date:   April 2010 (Final data collection date for primary outcome measure)

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553501

Show 31 study locations  Show 31 Study Locations

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)

Investigators
Study Chair:     Barbara W. Grant, MD     Vermont Cancer Center at University of Vermont    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000572604, CALGB-50701
First Received:   November 2, 2007
Last Updated:   October 4, 2008
ClinicalTrials.gov Identifier:   NCT00553501
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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