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A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma



- 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.

Inclusion Criteria


- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Sonali M. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

December 2018

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • adult lymphocyte predominant Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



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