Clinical trial · Interventional
Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
NCT00651443CI-TRIAL-00004259terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): A company's strategic decision to focus on areas whereit believes it can be competitive and decided to exit Oncology
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.
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, Non-Hodgkin's | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Galiximab | Drug | Galiximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Galiximab
Primary outcomes (1)
- measure
- Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.
- timeFrame
- 24 months
Secondary outcomes (1)
- measure
- 1) Safety and tolerability of Galiximab when administered as a single agent in an extended dosing regimen in previously untreated subjects with follicular NHL. 2) Evaluation of preliminary clinical activity of galiximab.
- timeFrame
- 48 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent (signed and dated). * Age equal or greater than 18 at the time of consent. * Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/ World Health Organization (WHO) classification (from initial diagnosis) Grades 1,2, or 3a. * At least 2 malignant lymph nodes of similar size (\>1 cm in minimal dimension) and location that are readily accessible for excisional biopsy at the time of study entry. * Consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor. * Acceptable hematologic, hepatic, and renal function parameters. * WHO Performance Status equal or less than 2. * Subjects of reproductive potential must agree to follow accepted birth control methods. Exclusion Criteria: * Presence of lymphoma in CNS. * Previous systemic anticancer treatment for NHL (including but not limited to radiation, myeloablative, or investigational therapy). * Concurrent treatment with systemic steroids within 14 days of Day 1. * Evidence of transformed lymphoma. * Presence of malignancies within 3 years of Study Day 1 (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer). * History of HIV infection or AIDS. * Serious nonmalignant disease. * Pregnant. * Inability to comply with study and follow-up procedures. * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.
References
Publications (0)
Data not yet available
No reference posted for this study.