Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B ) Identifier:
First received: August 14, 2007
Last updated: January 26, 2015
Last verified: January 2015

RATIONALE: Monoclonal antibodies, such as galiximab, 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.

PURPOSE: This phase II trial is studying how well galiximab works in treating patients with relapsed or refractory Hodgkin's lymphoma.

Condition Intervention Phase
Biological: galiximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall Response [ Time Frame: Duration of treatment (up to 10 years) ] [ Designated as safety issue: No ]

    Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.

    CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions.

Secondary Outcome Measures:
  • 12 Month Overall Survival Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method.

  • 6 Month Progression Free Survival Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Percentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method.

    Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion > 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node.

Enrollment: 30
Study Start Date: June 2008
Study Completion Date: October 2014
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Galaximab
Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
Biological: galiximab

Detailed Description:



  • To determine the response rate (complete and overall response) in patients with relapsed or refractory Hodgkin lymphoma (HL) treated with galiximab.


  • To assess the duration of response, progression-free survival, and overall survival of patients with relapsed or refractory HL.
  • To assess the safety and tolerability of galiximab in patients with relapsed or refractory HL.
  • To determine if FDG-PET correlates with outcome in patients with relapsed or refractory HL treated with galiximab.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive galiximab IV over 60 minutes on days 1, 8, 15, and 22 in month 1.
  • Extended induction therapy: Patients receive galiximab IV over 60 minutes once every four weeks in the absence of disease progression or unacceptable toxicity.

Patients also undergo FDG-PET/CT imaging at baseline and at time of first restaging (within 7 days prior to week 8 treatment).

After completion of study treatment, patients are followed periodically for 10 years.


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


  • Histologically confirmed classical Hodgkin lymphoma (HL):

    • 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
  • Recurrent or refractory disease after at least two prior standard chemotherapy regimens
  • Nodular lymphocyte predominant HL allowed
  • Measurable disease must be present on either physical examination or imaging studies

    • Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm
    • Evaluable or non-measurable disease alone is not acceptable including any of the following:

      • Bone lesions (lesions, if present, should be noted)
      • Bone marrow involvement (if present, this should be noted)
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
  • Ineligible for a stem cell transplantation
  • Patients eligible for CALGB-50502 should not be considered for this study
  • No known CNS involvement


  • ECOG performance status 0-2
  • ANC ≥ 500/μL
  • Platelet count ≥ 50,000/μL
  • Creatinine ≤ 2.0 mg/dL
  • Total bilirubin ≤ 2.0 mg/dL (no history of Gilbert Disease)
  • AST ≤ 2.5 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study
  • No known HIV infection


  • See Disease Characteristics
  • Recovered to ≤ grade 1 from all toxicities related to prior treatments
  • At least 4 weeks since prior chemotherapy, radiotherapy, or biologic anticancer therapy
  • Prior autologous and/or allogeneic stem cell transplantation allowed
  • No prior anti-CD80 antibody
  • No concurrent steroids, hormones, or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for non-disease-related conditions (e.g., insulin for diabetes)

    • The use of dexamethasone and other steroidal antiemetics is prohibited unless to treat acute grade 3 or 4 monoclonal antibody-associated infusion reactions not responsive to transient discontinuation of antibody infusion or acetaminophen and diphenhydramine
    • Dexamethasone is also allowed for re-treatment after an infusion reaction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00516217

  Show 56 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Sonali M. Smith, MD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B ) Identifier: NCT00516217     History of Changes
Other Study ID Numbers: CDR0000561185, U10CA031946, CALGB-50602
Study First Received: August 14, 2007
Results First Received: January 26, 2015
Last Updated: January 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent adult Hodgkin lymphoma
adult lymphocyte predominant Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on December 01, 2015