Trial record 16 of 314 for:
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Phase I/II of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL
This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Ronald Levy
Collaborator:
Information provided by (Responsible Party):
Ronald Levy, Stanford University
ClinicalTrials.gov Identifier:
NCT00490529
First received: June 20, 2007
Last updated: December 29, 2012
Last verified: December 2012
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Purpose
While autologous hematopoietic stem cell transplant (AHCT) has been shown to cure some subtypes of non-Hodgkin's lymphoma (NHL), mantle cell lymphoma (MCL) still has a prognosis marked by relapse. This study will evaluate the safety and efficacy of treating newly diagnosed MCL patients with an autologous, tumor-derived vaccine followed by re-infusion of vaccine-primed T cells combined with standard autologous hematopoietic stem cell transplant (AHCT). CpG-MCL vaccine is derived from each patient's own tumor, treated in vitro with the immunostimulatory CpG-enriched oligodeoxynucleotide - PF-3512676 - and irradiated. The overall treatment schema is that patients receive: induction chemotherapy, priming vaccinations, leukapheresis to harvest vaccine-primed T cells, preparative myeloablative chemotherapy followed by AHCT, re-infusion of vaccine-primed T-cells ('immunotransplant') and repeat vaccinations zero and three months post-AHCT.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Mantle-Cell |
Biological: CpG-MCL vaccine, primed T-cells Procedure: Autologous peripheral blood stem cell transplantation Procedure: CT scan Procedure: PET-CT scan Drug: PF-3512676 Drug: Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous "Immunotransplant" for Mantle Cell Lymphoma |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- The primary endpoint of the trial is freedom from molecular residual disease (MRD) at the landmark of one-year post-transplant. [ Time Frame: Samples for MRD analysis are collected every 3 months until one-year post transplant. ] [ Designated as safety issue: No ]After the one-year mark, samples for MRD analysis will be collected every 6 months for 3 years or until disease progression.
Secondary Outcome Measures:
- Secondary objectives are Time To Clinical Progression (TTP), and evaluation of anti-tumor immune responses after vaccination, and after immunotransplant. progression-free survival. [ Time Frame: 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 59 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | September 2020 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: "CpG-MCL" vaccine
Patients will initially receive three 'priming' CpG-MCL vaccinations in 21 days at 4-7 day intervals, followed by collection of "primed" T-Cells. Subsequently, within 72 hours of autologous hematopoetic cell transplant (AHCT)(standard of care procedure), the patient will receive his/her CpG-MCL vaccine and reinfusion of primed T cells ("immunotransplant"). At >/= 3 months after AHCT, when medically feasible, the patient will receive the final CpG-MCL vaccine. Regular follow-up research analysis of molecular residual disease will continue for 3 years or until disease progression.
|
Biological: CpG-MCL vaccine, primed T-cells
Other Name: CpG-activated, autologous tumor vaccine
Procedure: Autologous peripheral blood stem cell transplantation
Standard of Care
Other Name: Hematopoietic stem cell transplantation
Procedure: CT scan
Standard of Care
Other Name: X-ray computed tomography
Procedure: PET-CT scan
Standard of Care
Other Name: Poset emission tomography
Drug: PF-3512676
18 mg subcutaneous injection
Other Name: Pfizer
Drug: Rituximab
375 mg/m2 iv Standard of care.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must be newly diagnosed with MCL, have an accessible disease site for excisional biopsy or sufficient peripheral blood tumor burden to safely leukapherese.
- By standard clinical criteria be medically appropriate to receive induction chemotherapy and high-dose chemotherapy with AHCT.
- Must be between 18 to 70 years of age.
- Serum creatinine <2.0 or 24-hour creatinine clearance >60 ml/min.
- Patients must be HIV negative.
- ECOG performance status 0, 1, or 2.
- Patients must be capable of signing an informed consent.
Exclusion Criteria:
- Patients who are currently taking immunosuppressive medications.
- Severe psychological or medical illness.
- Patients may not be receiving any other investigational agents.
- Pregnant or lactating women.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490529
Contacts
| Contact: Holbrook Kohrt, MD, PhD | (650) 725-4968 | kohrt@stanford.edu |
| Contact: Emily Troutner | 650-725-4968 | troutner@stanford.edu |
Locations
| United States, California | |
| Stanford University Medical Center | Recruiting |
| Stanford, California, United States, 94305 | |
| Sub-Investigator: Holbrook Kohrt, MD, PhD | |
| Sub-Investigator: Ranjana Advani, MD | |
| Sub-Investigator: Robert Negrin, MD | |
| Sub-Investigator: David Miklos, MD, PhD | |
| Sub-Investigator: Wen Kai Weng, MD, PhD | |
| Sub-Investigator: Sally Arai, MD, PhD | |
| Sub-Investigator: Lauren Maeda, MD | |
Sponsors and Collaborators
Ronald Levy
Investigators
| Principal Investigator: | Ronald Levy | Stanford University |
More Information
Publications:
| Responsible Party: | Ronald Levy, Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00490529 History of Changes |
| Other Study ID Numbers: | LYMNHL0040, 96940, LYMNHL0040-BMT212, 5089 |
| Study First Received: | June 20, 2007 |
| Last Updated: | December 29, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013