Phase 2
N=30
Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00134082 ↗Enrolled (actual)
30
Serious AEs
50.0%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants With Grade 3-5 Adverse Events — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KGEL vaccine (Biological); Filgrastim (Biological); Rituximab (Biological); Cyclophosphamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 3-5 Adverse Events |
6 | — |
| PRIMARY Percentage of Participants With an Increase in Frequency of LMP2-specific CD8+ T Cells |
— | — |
| SECONDARY Survival |
31.5; 24.1 | — |
| SECONDARY Days to Neutrophil and Platelet Engraftment |
17; 21.5 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00134082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.