Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00101101
Recruitment Status : Active, not recruiting
First Posted : January 10, 2005
Results First Posted : September 4, 2013
Last Update Posted : February 5, 2018
National Cancer Institute (NCI)
Lymphoma Research Foundation
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Drug: Dexamethasone
Biological: Autologous Tumor Cell-Based Vaccine
Drug: IL-2

  Participant Flow

Recruitment Details
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
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
COMPLETED   23 [1] 
never received vaccine                20 
[1] Participants who received at least one vaccine injection.

  Baseline Characteristics

  Outcome Measures

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 ]

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Sophie Dessureault, M.D., Ph.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-1965

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT00101101     History of Changes
Other Study ID Numbers: MCC-13840
0406-654 ( Other Identifier: OBA )
First Submitted: January 7, 2005
First Posted: January 10, 2005
Results First Submitted: June 20, 2013
Results First Posted: September 4, 2013
Last Update Posted: February 5, 2018