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
|Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations|
|Forty three patients with stage II-IV histologically confirmed mantle cell lymphoma (MCL) in need of systemic chemotherapy were enrolled at the H. Lee Moffitt Cancer Center between February 2004 and July 2008.|
|Significant events and approaches for the overall study following participant enrollment, but prior to group assignment|
|No text entered.|
|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.
Participant Flow: Overall Study
|Vaccine and Conventional Therapy|
|never received vaccine||20|
|||Participants who received at least one vaccine injection.|
|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