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Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 PositivePhase 1NCT07020533

A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant

A Phase 1 study testing Biospecimen Collection, Electronic Health Record Review and Haploidentical Hematopoietic Cell Transplantation in people with Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive and Acute Lymphoblastic Leukemia, run by City of Hope Medical Center at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
Biospecimen Collection, Electronic Health Record Review and Haploidentical Hematopoietic Cell Transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
3 sitesUnited States
Study dates
9 Sep 2026to 14 Feb 2030
Phase
Phase 1

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • DONORS: Documented informed consent of the participant. This can be done in person or informed consent can be obtained remotely.
  • Remote consent, when appropriate, will be obtained per institutional guidelines.
  • Assent, when appropriate, will be obtained per institutional guidelines.
  • Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.
  • DONORS: Age: 18 - 75.
  • DONORS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
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  • DONORS: Agreement by females and males of childbearing potential* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and for up to 90 days post-vaccination.
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only).
  • RECIPIENTS: Documented informed consent of the participant and/or legally authorized representative. This can be done in person or informed consent can be obtained remotely.
  • Remote consent, when appropriate, will be obtained per institutional guidelines.
  • Assent, when appropriate, will be obtained per institutional guidelines.
  • Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.
  • RECIPIENTS: Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT.
  • RECIPIENTS: Age: 18 - 75.
  • RECIPIENTS: Planned peripheral blood stem cell (PBSC) or bone marrow (BM) 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 must 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.)
  • 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 judged appropriate by the clinical principal investigators (PIs), including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded**.
  • Adult cases of multiple myeloma (MM) are excluded as HCT is not standard of care for MM and is only performed in very advanced cases with an associated high risk of relapse and non-relapse mortality (NRM). Adults with aplastic anemia are excluded because their standard management includes T cell depletion with agents such as antithymocyte globulin (ATG), which is not permissible on this protocol. Patients undergoing a second haploHCT are not eligible (patients who have undergone a previous autologous HCT are eligible).
  • RECIPIENTS: Patients receiving myeloablative (MA) or reduced intensity conditioning (RIC) are allowed.
  • RECIPIENTS: CMV seropositive.
  • RECIPIENTS: Eligible haploidentical donors will have 2-4 mismatches if human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 typing is used; 2-5 mismatches if HLA-A, -B, -C, -DRB1, and -DQB1 typing is used; and 2-6 mismatches if HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 typing is used. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must demonstrate that they are a full haplotype match by being identical at a minimum of one allele (at high resolution deoxyribonucleic acid [DNA]-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1 if 8 allele typing is used; HLA-A, -B, -C, -DRB1, and -DQB1 if 10 allele typing is used; and HLA-A, -B, -C, -DRB1-, DQB1, and -DPB1 is 12 allele typing is used.
  • RECIPIENTS: Planned HCT with minimal to no-T cell depletion of graft.
  • RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted.
  • RECIPIENTS: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (to be performed within 45 days prior to day 1 of protocol therapy).
  • RECIPIENTS: Aspartate aminotransferase (AST) =< 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).
  • RECIPIENTS: Alanine aminotransferase (ALT) =< 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).
  • RECIPIENTS: Estimated creatinine clearance acceptable per institutional guidelines (to be performed within 45 days prior to day 1 of protocol therapy).
  • RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50%.
  • Note: To be performed within 45 days prior to day 1 of protocol therapy.
  • RECIPIENTS: If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).
  • If unable to perform pulmonary function tests: Oxygen (O2) saturation > 92% on room air.
  • Note to be performed within 45 days prior to day 1 of protocol therapy.
  • RECIPIENTS: Seronegative for HIV antigen (Ag)/antibody (Ab) combination (combo), hepatitis c virus (HCV)*, active hepatitis b virus (HBV) (surface antigen negative) and syphilis (RPR) within 2 months of registration and no history of disseminated cutaneous human papillomavirus (HPV) related disease.
  • If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.
  • RECIPIENTS: Meets other institutional and federal requirements for infectious disease titer requirements.
  • Note Infectious disease testing to be performed within 45 days prior to day 1 of protocol therapy.
  • RECIPIENTS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 45 days prior to day 1 of protocol therapy).
  • RECIPIENTS: Agreement by females and males of childbearing potential* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and up to 90 days post-HCT.
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only).

Who cannot join

  • DONORS: Any prior transplant to day 1 of protocol therapy (day 1 defined as the day after donors receive the Triplex vaccine).
  • DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.
  • DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after the study vaccine.
  • DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension.
  • DONORS: Sickling hemoglobinopathy including hemoglobin (Hb)SS, HbAS, HbSC.
  • DONORS: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes) are ineligible for Triplex vaccination.
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  • DONORS: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely and making informed consent impossible.
  • DONORS: Females only: Pregnant or breastfeeding.
  • DONORS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
  • DONORS: 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).
  • RECIPIENTS: Any prior investigational CMV vaccine.
  • RECIPIENTS: Experimental anti-CMV chemotherapy in the last 6 months.
  • RECIPIENTS: Live attenuated vaccines (planned medications from the time of HCT to day 70 post-HCT).
  • RECIPIENTS: Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) (planned medications from the time of HCT to day 70 post-HCT).
  • RECIPIENTS: Allergy treatment with antigen injections (planned medications from the time of HCT to day 70 post-HCT).
  • RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent (or CD34+ selection) (planned medications from the time of HCT to day 70 post-HCT).
  • RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)/valganciclovir (VAL), foscarnet (FOS), cidofovir, CMX-001, maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) (planned medications from the time of HCT to day 70 post-HCT).
  • RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment EXCEPT letermovir prophylaxis (prior to day 100) (planned medications from the time of HCT to day 70 post-HCT).
  • RECIPIENTS: Disease-based radiation therapy (not total body irradiation) (planned medications from the time of HCT to day 70 post-HCT).
  • RECIPIENTS: Other investigational product(s) - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited (planned medications from the time of HCT to day 70 post-HCT).
  • RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product (planned medications from the time of HCT to day 70 post-HCT).
  • RECIPIENTS: Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years.
  • RECIPIENTS: Patients considered by PI/consenting physicians to have a complicated prior therapy or HCT regimen, or who have a low survival probability (e.g., refractory leukemia and/or undergoing 2nd HCT).
  • RECIPIENTS: Poor risk disease/disease status including: Chronic myelogenous leukemia (CML) in blast crisis, acute myeloid leukemia (AML)/acute lymphoblastic leukemia (ALL) beyond 2nd remission, multiple myeloma, and aplastic anemia.
  • RECIPIENTS: Females only: Pregnant or breastfeeding.
  • RECIPIENTS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
  • RECIPIENTS: 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

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites, 3 recruiting

  • Northside Hospital

    Atlanta, Georgia, 30342

    Scott R. Solomon, 404-255-1930, ssolomon@bmtga.com

    Scott R. Solomon

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

    Lindsey R. Baden, 617-732-6801, lbaden@bwh.harvard.edu

    Lindsey R. Baden

    Recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Ryotaro Nakamura, 626-256-4673, RNakamura@coh.org

    Ryotaro Nakamura

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant

This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and/or effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate whether the multi-peptide cytomegalovirus-modified vaccinia Ankara vaccine (CMV-MVA Triplex [Triplex]) vaccination of stem cell donors (D) and recipients (R) alone or in combination with letermovir safely protects against CMV events for day (d)100 in the absence of preemptive therapy (PET) and to determine the recommended duration of letermovir use as phase 2 modality in the haploidentical stem cell transplantation (haploHCT)-R.

SECONDARY OBJECTIVES:

  1. To evaluate safety of Triplex in the haploHCT-R. II. To evaluate cumulative incidence of CMV events up to d180 post-hematopoietic stem cell transplant (HCT).

III. To evaluate CMV viremia levels over time in the HCT-R. IV. To evaluate cumulative incidence of CMV disease. V. To evaluate use of PET by the HCT-R.

EXPLORATORY OBJECTIVES:

  1. To assess levels and durability of CMV specific T cell immunity. II. To assess polyfunctional T cell responses and cell-surface memory markers until d180 post-HCT.

OUTLINE:

DONORS: Participants receive CMV-MVA Triplex vaccine intramuscularly (IM) once and then receive granulocyte colony stimulating factor (G-CSF) on study. Additionally, participants undergo apheresis on study as well as blood sample collection on study and may optionally undergo blood sample collection during follow up.

RECIPIENTS: Patients are assigned to 1 of 3 modalities.

MODALITY 1: Patients receive myeloablative conditioning during screening and undergo HCT from haploidentical vaccinated donor on day 0. Patients receive CMV-MVA Triplex vaccine IM once daily (QD) on days 28, 56 and 100 and receive letermovir intravenously (IV) over 1 hour or orally (PO) QD on days 7 to 100. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.

MODALITY 2: Patients receive myeloablative conditioning during screening and undergo HCT from haploidentical vaccinated donor on day 0. Patients receive CMV-MVA Triplex vaccine IM QD on days 28, 56 and 100 and receive letermovir IV over 1 hour or PO QD on days 7 to 28. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.

MODALITY 3: Patients receive myeloablative conditioning during screening and undergo HCT from haploidentical vaccinated donor on day 0. Patients receive CMV-MVA Triplex vaccine IM QD on days 28, 56 and 100. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 2 weeks until day 180 and then at day 365.

Being tested
Biospecimen Collection, Electronic Health Record Review, Haploidentical Hematopoietic Cell Transplantation, Letermovir, Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
Medical subject headings
Leukemia, Myeloid, Accelerated Phase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myeloid, Chronic-Phase, Hodgkin Disease, Myelodysplastic Syndromes, Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Haploidentical Hematopoietic Cell TransplantationProcedure or surgery

    Also called Haploidentical Stem Cell Transplantation, HLA-Haploidentical Hematopoietic Cell Transplantation, Stem Cell Transplantation, Haploidentical

    Undergo HCT

  • LetermovirDrug

    Also called 2-((4S)-8-Fluoro-2-(4-(3-methoxyphenyl)piperazin-1-yl)-3-(2-methoxy-5-(trifluoromethyl)phenyl)-4H-quinazolin-4-yl)acetic Acid, AIC246, MK-8228, Prevymis

    Given IV or PO

  • Multi-peptide CMV-Modified Vaccinia Ankara VaccineBiological

    Also called CMV-MVA Triplex Vaccine, Multi-antigen CMV-Modified Vaccinia Ankara Vaccine

    Given IM

  • Myeloablative ConditioningProcedure or surgery

    Also called Myeloablation, Myeloablative, Myeloablative Cytoreduction

    Receive myeloablative conditioning

  • PheresisProcedure or surgery

    Also called Apheresed, Apheresis, Blood Component Removal, Collection, Apheresis/Leukapheresis

    Undergo apheresis

  • Recombinant Granulocyte Colony-Stimulating FactorBiological

    Also called Recombinant Colony-Stimulating Factor 3, rhG-CSF

    Given G-CSF

Study groups in NCT07020533
Study groupRoleWhat they receive
Donors (CMV-MVA Triplex vaccine, G-CSF)ExperimentalParticipants receive CMV-MVA Triplex vaccine IM once and then receive G-CSF on study. Additionally, participants undergo apheresis on study as well as blood sample collection on study and may optionally undergo blood sample collection during follow up.
Receives: Procedure: Biospecimen Collection; Biological: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine; Procedure: Pheresis; Biological: Recombinant Granulocyte Colony-Stimulating Factor
Recipients, Modality 1 (CMV-MVA Triplex vaccine, letermovir)ExperimentalPatients receive myeloablative conditioning during screening and undergo HCT from haploidentical vaccinated donor on day 0. Patients receive CMV-MVA Triplex vaccine IM QD on days 28, 56 and 100 and receive letermovir IV over 1 hour or PO QD on days 7 to 100. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Procedure: Haploidentical Hematopoietic Cell Transplantation; Drug: Letermovir; Biological: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine; Procedure: Myeloablative Conditioning
Recipients, Modality 2 (CMV-MVA Triplex vaccine, letermovir)ExperimentalPatients receive myeloablative conditioning during screening and undergo HCT from haploidentical vaccinated donor on day 0. Patients receive CMV-MVA Triplex vaccine IM QD on days 28, 56 and 100 and receive letermovir IV over 1 hour or PO QD on days 7 to 28. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Procedure: Haploidentical Hematopoietic Cell Transplantation; Drug: Letermovir; Biological: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine; Procedure: Myeloablative Conditioning
Recipients, Modality 3 (CMV-MVA Triplex vaccine)ExperimentalPatients receive myeloablative conditioning during screening and undergo HCT from haploidentical vaccinated donor on day 0. Patients receive CMV-MVA Triplex vaccine IM QD on days 28, 56 and 100. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Procedure: Haploidentical Hematopoietic Cell Transplantation; Biological: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine; Procedure: Myeloablative Conditioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cytomegalovirus (CMV) reactivation prompting antiviral therapy

    Will evaluate for CMV reactivation prompting antiviral therapy. Will be evaluated in patients that received a stem cell infusion from a Triplex vaccinated haploidentical donor and received the first Triplex vaccination.

    Measured: From day 0 to day 100 post-hematopoietic stem cell transplant (HCT)

  2. CMV disease

    Will evaluate for CMV disease based on histology. Will be evaluated in patients that received a stem cell infusion from a Triplex vaccinated haploidentical donor and received the first Triplex vaccination.

    Measured: From day 0 to day 100 post-HCT

Secondary outcomes (15)

  1. Unacceptable toxicity

    Will evaluate for grade 3-4 adverse events based on Common Terminology Criteria for Adverse Events version 5.0 probably or definitely attributable to vaccination in both recipients and donors. Descriptive statistics will be used to summarize recipients and donor adverse events.

    Measured: Up to 28 days after the last Triplex vaccination

  2. Serious adverse events (SAE)

    Will evaluate for SAEs that are at least possibly related to Triplex vaccination in donors.

    Measured: Up to 365 days after Triplex vaccination

  3. Incidence of acute graft-versus-host disease (GVHD)

    Will evaluate for grade 3-4 acute GVHD. Documented/biopsy proven acute GVHD is graded according to Mount Sinai Acute GVHD International Consortium (MAGIC) grading. Cumulative incidence curves will be used to estimate acute GVHD.

    Measured: Up to day 180 post-HCT

  4. Non-relapse mortality (NRM)

    Will evaluate occurrence of NRM. Cumulative incidence curves will be used to estimate NRM.

    Measured: From HCT to death from other causes than disease relapse or progression, assessed up to day 180 post-HCT

  5. CMV events

    Will evaluate for CMV events. Death or relapse/progression prior to day 180 post-HCT will be counted as competing risk events. Patients who are alive and free of CMV events and relapse/progression at the last follow-up or day 180 post-HCT, whichever comes first, will be censored. Cumulative incidence curves will be used to estimate CMV events.

    Measured: Up to day 180 post-HCT

  6. CMV viremia

    Will evaluate for CMV viremia. Cumulative incidence curves will be used to estimate CMV viremia.

    Measured: From HCT to the date of two consecutive CMV quantitative polymerase chain reaction (qPCR) > 500 gc/mL/465 IU/mL, single event of CMV qPCR > 1500 CMV gc/mL/1,395 IU/mL, or CMV disease, whichever occurs first, assessed up to day 180 post-HCT

  7. Incidence of late CMV viremia

    Will evaluate for incidence of late CMV viremia. Cumulative incidence curves will be used to estimate CMV viremia.

    Measured: From HCT to the date of two consecutive CMV qPCR > 500 gc/mL/465 IU/mL, single event of CMV qPCR > 1500 CMV gc/mL/1,395 IU/mL, or CMV disease, whichever occurs first, assessed from day 100 to day 365 post-HCT

  8. Neutrophil engraftment

    Will evaluate time to neutrophil engraftment.

    Measured: From HCT to the first of 3 consecutive days with neutrophil count ≥ 0.5 X 10^3/uL

  9. Platelet engraftment

    Will evaluate time to platelet engraftment.

    Measured: From HCT to the first day of platelet count ≥ 20 X 10^3/uL independent of platelet transfusion support (date should reflect no transfusions in previous 7 days, and the first of 3 consecutive lab values on different days)

  10. Incidence of severe acute GVHD

    Will evaluate for grade 2-4 acute GVHD. Documented/biopsy proven acute GVHD is graded according to MAGIC grading. Cumulative incidence curves will be used to estimate acute GVHD.

    Measured: Up to day 180 post-HCT

  11. Incidence of severe chronic GVHD

    Will evaluate sever chronic GVHD. Documented/biopsy proven chronic GVHD is scored according to National Institutes of Health consensus staging. Cumulative incidence curves will be used to estimate chronic GVHD.

    Measured: Up to day 180 post-HCT

  12. NRM

    Will evaluate occurrence of NRM. Cumulative incidence curves will be used to estimate NRM.

    Measured: From HCT to death from other causes than disease relapse or progression, assessed up to day 365 post-HCT

  13. Relapse

    Will evaluate time to relapse. NRM is the competing risks event. Cumulative incidence curves will be used to estimate relapse.

    Measured: From HCT to the first observation of disease relapse or progression, assessed up to day 365 post-HCT

  14. Overall survival (OS)

    Will evaluate OS. OS is censored at the last follow-up if the last known status is alive. Kaplan-Meier curves will be used to estimate OS.

    Measured: From HCT to the date of death regardless of cause, assessed up to day 365 post-HCT

  15. CMV-specific T cell immunity

    Will evaluate levels and kinetics of CMV-specific T cell immunity, combined with immunophenotyping and functional studies. Repeated measures analysis of variance analyses will be used for immunological functions over time.

    Measured: Up to day 365 post-HCT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start9 Sep 2026
  3. Primary completion14 Feb 2030 (estimated)
  4. Study completion14 Feb 2030 (estimated)

Resources

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 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07020533
Sponsor's protocol ID
24168
Other IDs
NCI-2025-03633, 24168, P30CA033572
Status last verified
Oct 2026
First submitted
6 Jun 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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