Clinical trial · Interventional
Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma
Phase II Trial of FavId™ (Patient-Specific Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06
- 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Why stopped (as posted): Withdrawn as company has shut down and filed for bankruptcy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: Vaccines made from a person's cancer cells may make the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous immunoglobulin idiotype-KLH conjugate vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ during participation on study Favld-06
Secondary outcomes (4)
- measure
- Response rate by modified Cheson Criteria
- measure
- Duration of response by modified Cheson Criteria
- measure
- Time to progression
- measure
- Response rate improvement
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
* Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06
* Meets 1 of the following criteria:
* Received salvage therapy after completion of protocol FAV-ID-06
* At least 4 weeks, but no more than 4 months, since prior salvage therapy
* Did not receive salvage therapy after completion of protocol FAV-ID-06
* At least 4 weeks, but no more than 4 months, since completion of prior treatment on protocol FAV-ID-06
* No history of CNS lymphoma OR meningeal lymphomatosis
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No history of congestive heart failure
Pulmonary
* No history of compromised pulmonary function
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No active bacterial, viral, or fungal infection
* No psychiatric disorder
* No other serious nonmalignant disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* No prior allogeneic transplantation\*
* No prior rituximab regimen\* other than that administered on protocol FAV-ID-06 (rituximab 375 mg/m\^2 IV weekly for 4 weeks)
Chemotherapy
* No prior purine analogues\* (e.g., fludarabine or cladribine)
Endocrine therapy
* No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement)
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* Recovered from prior salvage therapy
* No prior or concurrent immunosuppressive therapy
* No prior investigational agents\*
* No other concurrent antilymphoma therapy NOTE: \*As salvage therapy administered between completion of protocol FAV-ID-06 and enrollment onto this studyReferences
Publications (0)
Data not yet available