Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositivePhase 2NCT02396134
Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
A Phase 2 study testing CMVpp65-A*0201 peptide vaccine and Laboratory Biomarker Analysis in people with Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Adult Acute Lymphoblastic Leukemia in Remission, run by City of Hope Medical Center at 5 sites in United States.
Trial summary
This randomized phase II trial studies how well vaccine therapy works in reducing the frequency of cytomegalovirus severe infections (events) in patients with hematologic malignancies undergoing donor stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission
- What is being tested?
- CMVpp65-A*0201 peptide vaccine and Laboratory Biomarker Analysis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Jun 2015to 19 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT
- Planned HCT for the treatment of the following hematologic malignancies:
- Lymphoma (Hodgkin and non-Hodgkin)
- Myelodysplastic syndrome
- Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status needs to be in hematologic remission by bone marrow and peripheral blood; persistent lymphadenopathy on computed tomography [CT] or CT/positron emission tomography [PET] scan without progression is allowed)
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- Acute myeloid leukemia in first or second remission
- Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase
- Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis; patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded
- HLA A*0201 High resolution, 4-digit typing is required at HLA-A2 to ensure A*0201 status.
- CMV seropositive (recipient)
- Planned related or unrelated HCT, with HLA donor allele matching; related donor must be an 8/8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using deoxyribonucleic acid (DNA)-based typing; unrelated donor must be an 8/8 match at HLA-A, -B, -C, and -DRB1 at high resolution using DNA-based typing; patients undergoing a second allo HCT are not eligible (patients who have undergone a previous autologous HCT are eligible)
- Planned HCT with no ex-vivo T cell depletion of graft; conditioning and immunosuppressive regimens according to institutional guidelines are permitted
- Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
- Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and active hepatitis B virus (HBV) (surface antigen negative) within 2 months of registration
- Agreement by females of childbearing potential and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for up to 90 days post-HCT; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
Who cannot join
- Any prior investigational CMV vaccine
- Experimental anti-CMV chemotherapy in the last 6 months
- Planned medications from the time of HCT to day 70 post-HCT:
- Live attenuated vaccines
- Medically indicated subunit (Engerix-B for HBV; Gardasil for human papilloma virus [HPV]) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections)
- Allergy treatment with antigens injections
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- Alemtuzumab or any equivalent in vivo T-cell depleting agent; this includes anti-thymocyte globulin (ATG) and post-transplant cyclophosphamide
- Antiviral medications with known therapeutic effects against CMV such as ganciclovir (GCV)/valine (VAL), foscarnet (FOS), cidofovir, hexadecyloxypropyl-cidofovir (CMX-001) and maribavir; acyclovir has no therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV)
- Other investigational product - concurrent enrollment in other clinical trials using an investigational product is prohibited
- Other medications that might interfere with the evaluation of the investigational product
- Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible
- Pregnant women and women who are lactating; breastfeeding should be discontinued if the mother is enrolled on this study
- Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/psychological issues, etc
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
City of Hope Medical Center
Duarte, California, 91010
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: A Phase II Randomized, Placebo-Controlled, Multicenter Trial to Evaluate Protective Function of an Optimized Dose of CMVPepVax in Recipients of an Allogeneic Hematopoietic Stem Cell Transplant
This randomized phase II trial studies how well vaccine therapy works in reducing the frequency of cytomegalovirus severe infections (events) in patients with hematologic malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help the body build an effective immune response and may reduce cytomegalovirus events after donor stem cell transplant.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if cytomegalovirus (CMV) peptide(Pep)vaccine(Vax) (CMVpp65-A*0201 peptide vaccine) increases levels, function and kinetics of CMV-specific T cell immunity in vaccinated compared to placebo treated human leukocyte antigen (HLA) A*0201 allogeneic CMV positive hematopoietic stem cell transplant (HCT) recipients (HCT-R+). (Entire cohort) II. To provide a preliminary evaluation of the incidence of CMV reactivation between day 56 and day 180 in patients who receive standard letermovir (Prevymis) prophylaxis (from day 14 through day 100), comparable to the evaluation of an expansion cohort in a pilot study, or the futility stage of a phase II trial. (Letermovir combination cohort) III. To determine if CMVPepVax increases levels, function and kinetics of CMV-specific T cell immunity in vaccinated HCT patients who receive standard Prevymis prophylaxis. (Letermovir combination cohort)
SECONDARY OBJECTIVES:
- To determine, within the constraints of a pilot cohort, if CMVPepVax reduces the frequency of CMV events alone or in combination with Prevymis defined as reactivation or CMV disease in HLA A*0201 allogeneic HCT-R+.
II. To evaluate the safety and tolerability of CMVPepVax by assessing the following: non-relapse mortality (NRM) at 100 days post HCT, severe (grade 3-4) acute graft versus host disease (GVHD) (aGVHD), and grade 3-4 adverse events (AEs) (Common Terminology Criteria for Adverse Events [CTCAE] 4.0) probably or definitely related to the vaccination within 2 weeks from each vaccination.
III. To characterize CMV reactivation and CMV disease in recipients of CMVPepVax compared to placebo by assessing time-to viremia (defined as number of days from transplantation to the date of >= 500 CMV gc/mL), duration of viremia, recurrence of viremia, incidence of late CMV viremia/disease (> 100 and =< 360 days post HCT), use of antiviral drugs (triggered by clinically significant viremia), cumulative number of CMV specific antiviral treatment days.
IV. To determine whether vaccination induces adaptive natural killer (NK) cell population changes, and increase in the highly cytotoxic memory NKG2C+ NK cells.
- To determine the impact of CMVPepVax on CMV immune reconstitution in patients who undergo treatment with antiviral agent Prevymis.
VI. To explore GVHD biomarkers and compare between the vaccine and placebo groups.
VII. To characterize CMV reactivation after day 180
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive CMVpp65-A*0201 peptide vaccine subcutaneously (SC) on days 28 and 56 after HCT.
ARM II: Patients receive placebo SC on days 28 and 56 after HCT.
After completion of study treatment, patients are followed up to day 365 after HCT.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Hodgkin Lymphoma, Adult Non-Hodgkin Lymphoma, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Being tested
- CMVpp65-A*0201 peptide vaccine, Placebo, Laboratory Biomarker Analysis
- Medical subject headings
- Leukemia, Myeloid, Accelerated Phase, Hodgkin Disease, Lymphoma, Non-Hodgkin, Leukemia, Myeloid, Chronic-Phase, Cytomegalovirus Infections, Hematologic Neoplasms, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMVpp65-A*0201 peptide vaccineBiological
Given SC
PlaceboOther
Also called placebo, Placebo, placebo therapy, PLCB, sham therapy
Given SC
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (CMVpp65-A*0201 peptide vaccine) | Experimental | Patients receive CMVpp65-A*0201 peptide vaccine SC on days 28 and 56 after HCT. Receives: Biological: CMVpp65-A*0201 peptide vaccine; Other: Laboratory Biomarker Analysis |
| Arm II (placebo) | Placebo comparator | Patients receive placebo SC on days 28 and 56 after HCT. Receives: Other: Placebo; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of CMV at 100 Days
The primary endpoint was CMV event. A CMV event encompasses detection of CMV by either qPCR (termed "reactivation": DNAemia at ≥500 gc/ml = 1250iu/ml) or by tissue histology (end-organ disease). The cumulative incidence was calculated as competing risks using the method of Gooley with death viewed as a competing risk.
Measured: Up to day 100 after HCT
Secondary outcomes (2)
Non-Relapse Mortality (NRM) at 100 Days
NRM was defined as death without recurrent or progressive disease after transplant. Probabilities of NRM were calculated as competing risks using the method of Gooley with relapse viewed as a competing risk.
Measured: Up to 100 days after transplant
Cumulative Incidence of Relapse at One Year
Probabilities of relapse were calculated as competing risks using the method of Gooley with death viewed as a competing risk.
Measured: Up to 365 days after HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study start29 Jun 2015
- Primary completion4 Mar 2018
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ryotaro Nakamura, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396134
- Sponsor's protocol ID
- 13494
- Other IDs
- NCI-2015-00283, 13494, R01CA181045
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2015
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gooley TA, Leisenring W, Crowley J, Storer BE. Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Stat Med. 1999 Mar 30;18(6):695-706. doi: 10.1002/(sici)1097-0258(19990330)18:63.0.co;2-o.
PubMed 10204198
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Placebo-Controlled, Multicenter Trial to Evaluate Protective Function of an Optimized Dose of CMVPepVax in Recipients of an Allogeneic Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT02396134
- Acronym / sponsor ID
- 13494
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Hodgkin Lymphoma, Adult Non-Hodgkin Lymphoma, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 4 Mar 2018 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Posted 12 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well vaccine therapy works in reducing the frequency of cytomegalovirus severe infections (events) in patients with hematologic malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help the body build an effective immune response and may reduce cytomegalovirus events after donor stem cell transplant.
Detailed description
PRIMARY OBJECTIVES:
- To determine if cytomegalovirus (CMV) peptide(Pep)vaccine(Vax) (CMVpp65-A*0201 peptide vaccine) increases levels, function and kinetics of CMV-specific T cell immunity in vaccinated compared to placebo treated human leukocyte antigen (HLA) A*0201 allogeneic CMV positive hematopoietic stem cell transplant (HCT) recipients (HCT-R+). (Entire cohort) II. To provide a preliminary evaluation of the incidence of CMV reactivation between day 56 and day 180 in patients who receive standard letermovir (Prevymis) prophylaxis (from day 14 through day 100), comparable to the evaluation of an expansion cohort in a pilot study, or the futility stage of a phase II trial. (Letermovir combination cohort) III. To determine if CMVPepVax increases levels, function and kinetics of CMV-specific T cell immunity in vaccinated HCT patients who receive standard Prevymis prophylaxis. (Letermovir combination cohort)
SECONDARY OBJECTIVES:
- To determine, within the constraints of a pilot cohort, if CMVPepVax reduces the frequency of CMV events alone or in combination with Prevymis defined as reactivation or CMV disease in HLA A*0201 allogeneic HCT-R+.
II. To evaluate the safety and tolerability of CMVPepVax by assessing the following: non-relapse mortality (NRM) at 100 days post HCT, severe (grade 3-4) acute graft versus host disease (GVHD) (aGVHD), and grade 3-4 adverse events (AEs) (Common Terminology Criteria for Adverse Events [CTCAE] 4.0) probably or definitely related to the vaccination within 2 weeks from each vaccination.
III. To characterize CMV reactivation and CMV disease in recipients of CMVPepVax compared to placebo by assessing time-to viremia (defined as number of days from transplantation to the date of >= 500 CMV gc/mL), duration of viremia, recurrence of viremia, incidence of late CMV viremia/disease (> 100 and =< 360 days post HCT), use of antiviral drugs (triggered by clinically significant viremia), cumulative number of CMV specific antiviral treatment days.
IV. To determine whether vaccination induces adaptive natural killer (NK) cell population changes, and increase in the highly cytotoxic memory NKG2C+ NK cells.
- To determine the impact of CMVPepVax on CMV immune reconstitution in patients who undergo treatment with antiviral agent Prevymis.
VI. To explore GVHD biomarkers and compare between the vaccine and placebo groups.
VII. To characterize CMV reactivation after day 180
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive CMVpp65-A*0201 peptide vaccine subcutaneously (SC) on days 28 and 56 after HCT.
ARM II: Patients receive placebo SC on days 28 and 56 after HCT.
After completion of study treatment, patients are followed up to day 365 after HCT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (CMVpp65-A*0201 peptide vaccine) | Experimental | Biological: CMVpp65-A*0201 peptide vaccine, Other: Laboratory Biomarker AnalysisPatients receive CMVpp65-A*0201 peptide vaccine SC on days 28 and 56 after HCT. |
| Arm II (placebo) | Placebo comparator | Other: Placebo, Other: Laboratory Biomarker AnalysisPatients receive placebo SC on days 28 and 56 after HCT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT
- Planned HCT for the treatment of the following hematologic malignancies:
- HLA A*0201 High resolution, 4-digit typing is required at HLA-A2 to ensure A*0201 status.
- CMV seropositive (recipient)
Key exclusion criteria (14 listed)
- Any prior investigational CMV vaccine
- Experimental anti-CMV chemotherapy in the last 6 months
- Planned medications from the time of HCT to day 70 post-HCT:
- Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible
- Pregnant women and women who are lactating; breastfeeding should be discontinued if the mother is enrolled on this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMVpp65-A*0201 peptide vaccineGiven SC | Biological | Arm I (CMVpp65-A*0201 peptide vaccine) |
| PlaceboAlso: placebo, Placebo, placebo therapy, PLCB, sham therapyGiven SC | Other | Arm II (placebo) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (CMVpp65-A*0201 peptide vaccine), Arm II (placebo) |
Primary outcome
Cumulative Incidence of CMV at 100 Days
Time frame: Up to day 100 after HCT
The primary endpoint was CMV event. A CMV event encompasses detection of CMV by either qPCR (termed "reactivation": DNAemia at ≥500 gc/ml = 1250iu/ml) or by tissue histology (end-organ disease). The cumulative incidence was calculated as competing risks using the method of Gooley with death viewed as a competing risk.
2 secondary outcomes
Non-Relapse Mortality (NRM) at 100 Days
Time frame: Up to 100 days after transplant
Cumulative Incidence of Relapse at One Year
Time frame: Up to 365 days after HCT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 10204198Gooley TA, Leisenring W, Crowley J, Storer BE. Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Stat Med. 1999 Mar 30;18(6):695-706. doi: 10.1002/(sici)1097-0258(19990330)18:63.0.co;2-o.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryotaro Nakamura, MD principal investigator
City of Hope Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CMVpp65-A*0201 peptide vaccine and Laboratory Biomarker Analysis in people with Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Adult Acute Lymphoblastic Leukemia in Remission, run by City of Hope Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of CMV at 100 Days (time frame: Up to day 100 after HCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.