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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Lymphoma Research Foundation
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute Identifier:
First received: January 7, 2005
Last updated: March 17, 2017
Last verified: March 2017
Results First Received: June 20, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   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

  Baseline Characteristics
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Population Description
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.

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.

Baseline Measures
   Vaccine and Conventional Therapy 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      18  41.9% 
>=65 years      25  58.1% 
[Units: Participants]
Median (Full Range)
 (47 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      9  20.9% 
Male      34  79.1% 
Region of Enrollment 
[Units: Participants]
United States   43 

  Outcome Measures
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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
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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.

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