Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment|
Biological: Autologous Tumor Cell-Based Vaccine
|Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.|
|All participants who started the study.|
|Vaccine and Conventional Therapy||
Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.
Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.
Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|Vaccine and Conventional Therapy|
|Between 18 and 65 years||18|
Median (Full Range)
(47 to 81)
Region of Enrollment
|1. Primary:||Rate of Immunological Response to Vaccination [ Time Frame: 4 months per participant ]|
|2. Secondary:||Occurrence of Related Serious Adverse Events (SAEs) [ Time Frame: 4 months per participant ]|
|3. Secondary:||Median Event Free Survival (EFS) [ Time Frame: 18 months ]|
Limitations and Caveats
|Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data|
|With a median follow-up of 67 months, the median overall survival (OS) has not yet been reached.|
|All Principal Investigators ARE employed by the organization sponsoring the study.|
Results Point of Contact:
Organization: H. Lee Moffitt Cancer Center and Research Institute
|Responsible Party:||H. Lee Moffitt Cancer Center and Research Institute|
|ClinicalTrials.gov Identifier:||NCT00101101 History of Changes|
|Other Study ID Numbers:||
0406-654 ( Other Identifier: OBA )
|Study First Received:||January 7, 2005|
|Results First Received:||June 20, 2013|
|Last Updated:||May 6, 2016|
|Health Authority:||United States: Food and Drug Administration