Clinical trial · Interventional
Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma
NCT00516217CI-TRIAL-00022851completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| galiximab | Biological | Galiximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Galaximab
- description
- 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
- interventionNames
- Biological: galiximab
Primary outcomes (1)
- measure
- Overall Response
- timeFrame
- Duration of treatment (up to 10 years)
- description
- 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 outcomes (2)
- measure
- 12 Month Overall Survival Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* 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
PATIENT CHARACTERISTICS:
* 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
PRIOR CONCURRENT THERAPY:
* 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 reactionReferences
Publications (0)
Data not yet available
No reference posted for this study.