Clinical trial · Interventional
Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
Phase III, Randomized, Double Blind, Placebo-Controlled Trial of Favldand GM-CSF Versus Placebo and GM-CSF Following Rituximab in Subjects With Follicular 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Why stopped (as posted): Withdrawn as company has shut down and filed for bankruptcy
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow and peripheral blood. It is not yet known whether combining rituximab and GM-CSF with vaccine therapy may cause a stronger immune response and kill more cancer cells. PURPOSE: This randomized phase III trial is studying giving rituximab and GM-CSF together with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating patients with newly diagnosed, relapsed, or refractory B-cell non-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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous immunoglobulin idiotype-KLH conjugate vaccine | Biological | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to progression after 248 patients have progressed
Secondary outcomes (4)
- measure
- Response rate improvement after 248 patients have progressed
- measure
- Overall complete response rate by modified Cheson Criteria after 248 patients have progressed
- measure
- Duration of response by modified Cheson Criteria after 248 patients have progressed
- measure
- Safety by Common Toxicity Criteria (CTC) after 248 patients have progressed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)
* Grade 1, 2, or 3
* Meets 1 of the following criteria for treatment with rituximab:
* Treatment naïve
* Relapsed or refractory disease after prior chemotherapy
* Relapsed after a prior documented response (i.e., complete or partial response) to rituximab of at least 6 months duration
* Tumor accessible for biopsy OR existing biopsy material (taken within the past 6 months) suitable for vaccine preparation
* Measurable or evaluable disease after tumor tissue procurement for vaccine production
* No more than 2 prior treatment regimens for NHL
* Single regimens include any of the following:
* Maintenance rituximab
* Rituximab administered once weekly for 8 courses
* Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus rituximab\* NOTE: \*CHOP followed by rituximab at time of relapse is considered 2 treatment regimens
* No history of CNS lymphoma or meningeal lymphomatosis
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 75,000/mm\^3 (unless related to bone marrow involvement by lymphoma)
* Hemoglobin ≥ 10g/dL
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No congestive heart failure
Pulmonary
* No compromised pulmonary function
Immunologic
* HIV negative
* No prior allergic response to GM-CSF
* No active bacterial, viral, or fungal infection
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No psychiatric disorder that would preclude study participation
* No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other serious nonmalignant disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* See Chemotherapy
* At least 4 weeks since prior immunotherapy
* No prior radiolabeled anti-lymphoma antibody (e.g., iodine I 131 tositumomab or ibritumomab tiuxetan)
* No prior autologous or allogeneic stem cell transplantation
* No prior lymphoma-specific idiotype immunotherapy (e.g., Id vaccine)
* No prior investigational vaccine or immunotherapeutic containing keyhole limpet hemocyanin (KLH)
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* More than 9 months since prior fludarabine
* More than 2 years since prior chemotherapy/rituximab combination therapy (e.g., CHOP/rituximab or cyclophosphamide, vincristine, and prednisone \[CVP\]/rituximab)
* No more than 6 total prior treatment courses with fludarabine
Endocrine therapy
* No concurrent steroids for allergic reaction to sargramostim (GM-CSF)
Radiotherapy
* See Biologic therapy
* At least 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* At least 4 weeks since prior experimental therapy
* No concurrent systemic immunosuppressive therapy
* No other concurrent anti-lymphoma therapyReferences
Publications (1)
- RESULTFreedman A, Neelapu SS, Nichols C, Robertson MJ, Djulbegovic B, Winter JN, Bender JF, Gold DP, Ghalie RG, Stewart ME, Esquibel V, Hamlin P. Placebo-controlled phase III trial of patient-specific immunotherapy with mitumprotimut-T and granulocyte-macrophage colony-stimulating factor after rituximab in patients with follicular lymphoma. J Clin Oncol. 2009 Jun 20;27(18):3036-43. doi: 10.1200/JCO.2008.19.8903. Epub 2009 May 4. PMID 19414675