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Vaccine Therapy for Hematological Malignancies

Phase 1
Waitlist Available
Led By Ryotaro Nakamura
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 180
Awards & highlights

Study Summary

This trial tests a vaccine to prevent CMV infection in cancer patients undergoing a donor stem cell transplant. The vaccine may help the body build an effective immune response to CMV.

Eligible Conditions
  • Extramedullary Plasmacytoma
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Hodgkin's Lymphoma
  • Lymphoma
  • Myelodysplastic Syndrome
  • Mycosis Fungoides/Sezary Syndrome
  • Burkitt Lymphoma
  • Lymphoblastic Lymphoma
  • Polycythemia Vera
  • Mantle Cell Lymphoma
  • Monoclonal Gammopathy
  • Cytomegalovirus
  • Chronic Lymphocytic Leukemia
  • Multiple Myeloma
  • Chronic Myelogenous Leukemia
  • Non-Contiguous Diffuse Large B-Cell Lymphoma
  • Cutaneous T-Cell Lymphoma
  • Hairy Cell Leukemia
  • Adult T-Cell Leukemia/Lymphoma
  • MALT Lymphoma
  • Acute Lymphoblastic Leukemia
  • Primary Myelofibrosis
  • Plasmacytoma
  • T-Cell Lymphoblastic Leukemia
  • Adult Hodgkin's Lymphoma
  • Prolymphocytic Leukemia
  • Acute Myeloid Leukemia
  • Leukemia
  • Chronic Myelomonocytic Leukemia
  • Adult Acute Myeloid Leukemia
  • Nodal Marginal Zone Lymphoma
  • Essential Thrombocythemia
  • Acute Promyelocytic Leukemia
  • Nasal Lymphoma
  • Anaplastic Lymphoma
  • Peripheral T-Cell Lymphoma
  • Lymphoproliferative Disorder
  • Central Nervous System Lymphoma
  • Diffuse Large Cell Lymphoma
  • Large Granular Lymphocyte Leukemia
  • Waldenström's Macroglobulinemia
  • Adult Diffuse Large Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • Myelodysplastic Syndromes (MDS)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety based on assessment of GVHD, graded according to the Keystone Consensus system and adverse events (AEs) based on National Cancer Institute (NCI) CTCAE version 4.03
Secondary outcome measures
Immunogenicity evaluated by monitoring CMV-specific CD8+ T cells by multi color flow cytometric analyses

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (vaccine therapy)Experimental Treatment2 Interventions
Patients receive Tet-CMV + PF03512675 SC on days 28 and 56 post-HCT.
Group II: Arm II (control)Active Control1 Intervention
Patients undergo immune monitoring only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tetanus-CMV fusion peptide vaccine
2006
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,928,483 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
568 Previous Clinical Trials
1,924,624 Total Patients Enrolled
Ryotaro NakamuraPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
216 Total Patients Enrolled

Media Library

tetanus-CMV fusion peptide vaccine Clinical Trial Eligibility Overview. Trial Name: NCT01588015 — Phase 1
Diffuse Large B-Cell Lymphoma Research Study Groups: Arm I (vaccine therapy), Arm II (control)
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: tetanus-CMV fusion peptide vaccine Highlights & Side Effects. Trial Name: NCT01588015 — Phase 1
tetanus-CMV fusion peptide vaccine 2023 Treatment Timeline for Medical Study. Trial Name: NCT01588015 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Biology of Blood and Marrow TransplantationJournal
Rapid Acquisition of Cytomegalovirus-specific T Cells with a Differentiated Phenotype, in Nonviremic Hematopoietic Stem Transplant Recipients Vaccinated with Cmvpepvax
La Rosa, Corinna, Jeffrey Longmate, Chetan Raj Lingaraju, Qiao Zhou, Teodora Kaltcheva, Nicola Hardwick, Ibrahim Aldoss, Ryotaro Nakamura, and Don J. Diamond. 2019. “Rapid Acquisition of Cytomegalovirus-specific T Cells with a Differentiated Phenotype, in Nonviremic Hematopoietic Stem Transplant Recipients Vaccinated with Cmvpepvax”. Biology of Blood and Marrow Transplantation. Elsevier BV. doi:10.1016/j.bbmt.2018.12.070.
The Lancet HaematologyJournal
Viraemia, Immunogenicity, and Survival Outcomes of Cytomegalovirus Chimeric Epitope Vaccine Supplemented with PF03512676 (cmvpepvax) in Allogeneic Haemopoietic Stem-cell Transplantation: Randomised Phase 1b Trial
Nakamura, Ryotaro, Corinna La Rosa, Jeffrey Longmate, Jennifer Drake, Cynthia Slape, Qiao Zhou, Melanie G Lampa, et al.. 2016. “Viraemia, Immunogenicity, and Survival Outcomes of Cytomegalovirus Chimeric Epitope Vaccine Supplemented with PF03512676 (cmvpepvax) in Allogeneic Haemopoietic Stem-cell Transplantation: Randomised Phase 1b Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(15)00246-x.
clinicaltrials.govStudy
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
2012. "Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01588015.
~3 spots leftby May 2025
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