Clinical trial · Interventional
Rituximab + GM-CSF in Patients With Follicular B-Cell Lymphoma
Rituximab (IDEC-C2B8) Plus GM-CSF in Patients With Follicular B-Cell Lymphoma
NCT01939730CI-TRIAL-00019694completedPhase 2ClinicalTrials.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)
The goal of this clinical research study is to see if using the drugs Rituximab (IDEC-C2B8) and Granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine) together is better than using rituximab alone to treat follicular B-cell lymphomas. The safety of this treatment will also be studied.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab + GM-CSF
- description
- All patients receive one (1) course of therapy consisting of four (4) doses of rituximab, a single dose 375 mg/m\^2 administered once weekly for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly (tiw) for 8 weeks, starting 1 hour before the first dose of rituximab. In selected cases, the GM-CSF starts 1 week before, or 1 day after, the first rituximab dose.
- interventionNames
- Drug: Rituximab
- Drug: GM-CSF
Primary outcomes (1)
- measure
- Overall Response Rate of Rituximab plus GM-CSF of repeat doses (once weekly times four)
- timeFrame
- 1 month
- description
- Response Rate is the number of participants with response compared to total. Response definitions: Complete response (CR) defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays. Complete response "unconfirmed" (CRu) defined on the basis of minimal residual abnormalities on x-ray such as a residual mass \<25% of original measurement with no palpable disease on physical examination. Partial response (PR) defined as 50-75% reduction in the product of palpable tumor diameters of in the tumor volume measurements by radiologic criteria or any palpable disease such as peripheral node(s) \> 1 cm in diameter or palpable abdominal mass with histological evidence of lymphoma cells. Minor response or failure includes \<50% tumor shrinkage, or \> 50% but with tumor regrowth between courses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed follicular B-cell lymphoma. This can include relapsed patients, who have had no prior rituximab therapy, or previously untreated patients. Previously untreated patients should be made aware of higher priority protocols such as combination chemo-immunotherapy protocols, but if they decline that, they can be entered on this protocol. 2. Males or females, 18 years or older; expected survival of =/\> 4 months; performance status of 0, 1 or 2. 3. Demonstrable monoclonal cluster of differentiation antigen 20 (CD20)-positive B-cell population. 4. Acceptable hematologic status including: i. hemoglobin (Hgb) =/\> 8.0 gm/dL ii. White blood count (WBC) =/\> 3.0 x 10\^3/mm\^3(x 10\^9/L) iii. Absolute granulocyte count =/\> 1.5 x 10\^3/mm\^3 iv. Platelet count =/\>75 x 10\^3/mm\^3 e. Adequate renal function (serum creatinine ≤ 2mg/dl) Exclusion Criteria: 1. presence of Central Nervous System (CNS) Lymphoma 2. chronic lymphocytic leukemia (CLL) 3. small lymphocytic lymphoma 4. therapy in prior 3 weeks (6 weeks for nitrosourea; 6 months for Bone Marrow Transplantation (BMT)) 5. patients who received prior rituximab or other anti-CD20 therapy 6. serious non-malignant disease, or other malignancy 7. active infection 8. history of HIV infection i pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.