Clinical Trials Logo
  1. Home
  2. Non-Hodgkins Lymphoma
  3. NCT00091676

Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma — BiovaxID  

Non-Hodgkins Lymphoma Clinical Trial

Official title:
Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission

Clinical Trial Summary

The primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their first complete remission.

Clinical Trial Description

Patients with Stage III-IV follicular lymphoma and tumor > 2cm (Stage II allowed if tumor > 5cm), previously untreated by other than local radiation, provide tumor material by tissue biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the immunogenic protein KLH. After completing PACE or CHOP-R chemotherapy and achieving a complete remission, followed by a waiting period to reconstitute the immune system, patients who remain in remission randomized to the active treatment arm receive a series of 5 idiotype vaccinations accompanied by the immune stimulant GM-CSF. Patients randomized to the control arm receive a time-matched series of KLH injections also accompanied by GM-CSF. Patients are subsequently studied to observe their immune responses both to the non-specific immune stimulating agents and for the specific immune response to the vaccine. Patients are followed for a minimum of 4 years post-randomization or until relapse. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00091676
Study type Interventional
Source Biovest International
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 2000
Completion date December 2012
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04240704 - Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL Phase 1
Active, not recruiting NCT04188678 - Resiliency in Older Adults Undergoing Bone Marrow Transplant N/A
Recruiting NCT00807196 - Zevalin With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Non Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT00764829 - Blood Samples to Evaluate Biomarkers of Donor Chimerism N/A
Completed NCT00726934 - The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients N/A
Completed NCT01517581 - Brown Fat Activity and White Fat Accumulation N/A
Completed NCT00193505 - Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma Phase 2
Terminated NCT01744912 - Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies Phase 1
Terminated NCT01500161 - Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match Phase 2
Active, not recruiting NCT03533283 - An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma Phase 1/Phase 2
Active, not recruiting NCT00001379 - Treatment and Natural History Study of Lymphomatoid Granulomatosis Phase 2
Completed NCT00574730 - CHOP/Rituximab Followed by Maintenance PEG Intron in Treatment of Indolent/Follicular Non-Hodgkin's Lymphoma N/A
Completed NCT00901225 - Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant Phase 2
Terminated NCT01598025 - Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor N/A
Terminated NCT01326728 - Relapsed Malignant Blood Cancer After Allogeneic Hematopoietic Stem Cell Transplantation
Completed NCT01290549 - A Study of Escalating Doses of Polatuzumab Vedotin in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and Polatuzumab Vedotin in Combination With Rituximab in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma Phase 1
Completed NCT00837200 - Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies Phase 2
Completed NCT00807677 - A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies Phase 1
Terminated NCT00054834 - Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma Phase 1
Terminated NCT00003500 - Antineoplaston Therapy in Treating Patients With Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma Phase 2