Clinical trial · Interventional
CHOP-Rituximab Augmented With GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma
Phase II Trial of CHOP-Rituximab Augmented With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual was too slow. Trial terminated
Summary
Brief summary (as posted)
The primary goal of this study is to determine the effects (good and bad) of Granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with Cytoxan, Adriamycin, Vincristine, Prednisone, Rituximab (CHOP-R) on diffuse Large B cell Non-Hodgkin's lymphoma (DLBCL). The standard of care for DLBCL is the combination of drugs known as CHOP-Rituximab (CHOP-R). The drugs that make up CHOP-R are the chemotherapy drugs cyclophosphamide, doxorubicin and vincristine, prednisone and rituximab. GM-CSF is a drug that stimulates the immune system by increasing the numbers of white blood cells. Previous research has shown that GM-CSF might help rituximab to be more effective in treating lymphoma.
Conditions
Conditions (3)
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, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Lymphoma, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHOP | Drug | — | UNRESOLVED |
| GM-CSF | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GMCSF-RCHOP
- interventionNames
- Drug: GM-CSF
- Drug: CHOP
- Drug: Rituximab
Primary outcomes (1)
- measure
- To determine the safety of GM-CSF when administered in combination with CHOP-R to patients with previously untreated diffuse large B cell non-Hodgkin's lymphoma.
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- To assess the response rate, 2-year event-free survival and overall survival with CM-CSF and CHOP-R in this patient population
- measure
- to analyze the biologic activity of GM-CSF at this dosing schedule and timing.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of diffuse large B cell Non-Hodgkin's lymphoma with characteristic immunophenotypic profile * Patient has not received any prior anti-cancer therapy for lymphoma * Tumor tissue confirmed to express the cluster of differentiation antigen 20 antigen by flow cytometry or immunohistochemistry * Measurable disease as defined by a tumor mass of 1cm or greater in one dimension * Stage II (abdominal-not radiotherapy appropriate), III, or IV disease * Age \> 18 years * Performance Status of 0-2 * Laboratory parameters as outlined in protocol * Patient agrees to use birth control Exclusion Criteria: * Known central nervous system involvement by lymphoma * Serious uncontrolled concurrent illness such as active coronary artery disease, severe lung disease, heart failure, active alcohol abuse, active concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix * Any evidence of prior natural exposure to Hepatitis B * Active rheumatologic disease which may be exacerbated by GM-CSF * Cardiac ejection fraction less than 45% * Known HIV disease * Patient is pregnant or nursing * Patient is receiving other investigational drugs
References
Publications (0)
Data not yet available