Clinical trial · Interventional
Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma
Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma
- 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)
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Vaccines made from another person's cancer cells may help the body build an effective immune response to kill cancer cells. Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells PURPOSE: This phase I/II trial is studying how well giving rituximab together with cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| KGEL vaccine | Biological | — | UNRESOLVED |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immunotherapy
- description
- All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.
- interventionNames
- Biological: KGEL vaccine
- Biological: Filgrastim
- Biological: Rituximab
- Drug: Cyclophosphamide
Primary outcomes (2)
- measure
- Number of Participants With Grade 3-5 Adverse Events
- timeFrame
- Up to 36 months
- description
- Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention.
- measure
- Percentage of Participants With an Increase in Frequency of LMP2-specific CD8+ T Cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed classical Hodgkin's lymphoma * Relapsed disease with achievement of at least a partial response or a metabolic response to most recent salvage therapy * No primary induction failure, defined as disease progression during or within 2 months after completion of first-line therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 Hepatic * Bilirubin ≤ 2.0 mg/dL\* NOTE: \*Unless due to lymphoma or Gilbert's syndrome Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * Ejection fraction ≥ 45% by echocardiogram or MUGA Pulmonary * DLCO ≥ 50% of predicted (corrected for alveolar volume) Immunologic * No known HIV positivity * No active infection requiring oral or IV antibiotics * No autoimmune or other disease requiring long-term systemic steroids or other long-term immunosuppressants Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to tolerate high-dose therapy * No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior bone marrow transplantation Endocrine therapy * Not specified Radiotherapy * Concurrent radiotherapy for disease progression after high-dose cyclophosphamide allowed at the discretion of the principal investigator Surgery * Not specified
References
Publications (0)
Data not yet available