Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma
|ClinicalTrials.gov Identifier: NCT00101101|
Recruitment Status : Active, not recruiting
First Posted : January 10, 2005
Results First Posted : September 4, 2013
Last Update Posted : February 5, 2018
|Study Design:||Intervention Model: Single Group Assignment; Masking: None (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.|