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Vedolizumab for Preventing Graft Versus Host Disease After Transplant

This study is looking at whether adding vedolizumab to standard treatments (post-transplant cyclophosphamide and short course tacrolimus) can help prevent graft versus host disease (GVHD) in patients receiving a stem cell transplant. GVHD is when the donor cells attack your body. This study is for people aged 18 to 80 with certain blood cancers like leukemia or myelodysplastic syndrome who are having an allogeneic hematopoietic cell transplant (HCT), which is a transplant using donor stem cells. Researchers want to see if this combination is safe and effective in preventing GVHD. The study aims to enroll 35 participants.

Study design
This is a Phase II interventional study, meaning all participants will receive the study treatment. It aims to enroll 35 participants.
What's involved
You would undergo an allogeneic HCT, have blood samples collected, bone marrow biopsies, and CT scans. The primary safety endpoints are measured up to day +30 after starting vedolizumab.
Compensation
Not stated in the trial record.
Follow-up
The study will assess outcomes like acute GVHD-free survival up to day +180 after transplant, and overall survival, progression-free survival, and chronic GVHD up to 1 year post-transplant.

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NCT06815003

Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning

Recruiting
PHASE2Ages 18–80InterventionalTreatment
City of Hope Medical Center
~35 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Allogeneic Hematopoietic Stem Cell TransplantationBiospecimen CollectionBone Marrow BiopsyComputed TomographyCyclophosphamideEchocardiography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of primary engraftment failure (Safety lead-in segment)
Measured over From starting the first dose of vedolizumab to the first observation of event, day +30, whichever comes first
+4 more outcomes measured

Conditions

Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Graft Versus Host Disease
Myelodysplastic Syndrome
Myeloproliferative Neoplasm

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic SyndromeMyeloproliferative Neoplasm

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Monzr M. Al Malki · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Monzr M. Al Malki
[email protected]
626-218-2405
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: ≥ 18 and ≤ 80 years old
Note: Patients \> 70 years of age must have Karnofsky performance status ≥ 80 and hematopoietic cell transplantation-comorbidity index (HCT-CI) ≤ 2
Karnofsky performance status ≥ 70%
Patients with the following diagnosis, eligible to undergo allogeneic HCT from an 8/8 match related/unrelated donor (A, B, C, DR by high resolution typing)
Acute Leukemias (acute myeloid leukemia \[AML\] or acute lymphoblastic leukemia \[ALL\]) in complete remission with bone marrow (BM) blast of \< 5%
Myelodysplastic syndrome (blast \< 10%)
Myeloproliferative neoplasm (MPN) other than myelofibrosis (MF) needing HCT
Chronic myelomonocytic leukemia (CMML)
Hemoglobin ≥ 9g/dL (within 30 days prior to day 1 of protocol therapy)
NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement
Total bilirubin ≤ 2.0 mg/dL (unless has Gilbert's disease) AND serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) \< 5 times the upper limit of normal (ULN) (within 30 days prior to day 1 of protocol therapy)
Aspartate aminotransferase (AST) =\< 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)
Alanine aminotransferase (ALT) =\< 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)
Creatinine clearance of ≤ 1.5 mg/dL or ≥ 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 30 days prior to day 1 of protocol therapy)
Left ventricular ejection fraction (LVEF) ≥ 50%
Note: To be performed within 28 days prior to day 1 of protocol therapy
IF ABLE TO PERFORM PULMONARY FUNCTION TESTS: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)
Note To be performed within 28 days prior to day 1 of protocol therapy
IF UNABLE TO PERFORM PULMONARY FUNCTION TESTS: Oxygen (O2) saturation \> 92% on room air
Note To be performed within 28 days prior to day 1 of protocol therapy
Seronegative for HIV antigen/antibody (Ag/Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 30 days prior to day 1 of protocol therapy)
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Tuberculosis test (within 30 days prior to day 1 of protocol therapy)
Patients with positive tuberculosis (TB) test results will have infectious disease (ID) evaluation and post HCT therapy with isoniazid (INH) for 6 months with ID follow up. Vaccinated patients will need negative chest X-ray results
Meets other institutional and federal requirements for infectious disease titer requirements
Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 30 days prior to day 1 of protocol therapy)
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion

Prior allogeneic HCT
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Note: Conditioning regimen within 14 days prior to day 1 of protocol therapy is not considered as an exclusion criterion. Patients on maintenance chemotherapy with agents listed are not excluded
Other investigational drugs for GVHD prophylaxis
Herbal medications
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
Clinically significant uncontrolled illness
Active infection not responding to antibiotics
Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Females only: Pregnant or breastfeeding
Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
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
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)

What this trial measures

  • Incidence of primary engraftment failure (Safety lead-in segment)From starting the first dose of vedolizumab to the first observation of event, day +30, whichever comes first

    Will be assessed as an unacceptable toxicity (UT). Will include type, severity, duration, and attribution/association with the study regimen and dose limiting toxicity (DLT) occurrence. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including, but not limiting infections, other adverse events of special interest, and severe adverse events. Point estimates and corresponding exact 90% confidence intervals (CIs) will be provided for each measure of toxicity/adverse events.

  • Incidence of severe infusion reaction (Safety lead-in segment)From starting the first dose of vedolizumab to the first observation of event, day +30, whichever comes first

    Will be assessed as a UT. Will assess severe infusion reactions, grade 4 per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0, after receiving the 1st or 2nd dose of vedolizumab. Will include type, severity, duration, and attribution/association with the study regimen and DLT occurrence. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including, but not limiting infections, other adverse events of special interest, and severe adverse events. Point estimates and corresponding exact 90% CIs will be provided for each measure of toxicity/adverse events.

  • Incidence of grade 4-5 adverse events (Safety lead-in segment)From starting the first dose of vedolizumab to the first observation of event, day +30, whichever comes first

    Will be assessed as a UT. Will assess grade 4-5 adverse events based on CTCAE v 5.0 probably or definitely attributable to vedolizumab. Will include type, severity, duration, and attribution/association with the study regimen and DLT occurrence. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including, but not limiting infections, other adverse events of special interest, and severe adverse events. Point estimates and corresponding exact 90% CIs will be provided for each measure of toxicity/adverse events.

  • Non-relapse mortality (NRM) (Safety lead-in segment)From date of stem cell infusion until non-disease related death, assessed up to 1 year post-hematopoietic cell transplant (HCT)

    Will be assessed as a UT. Defined as death occurring in a patient from causes other than relapse or progression. Deaths from relapse/progression will be considered a competing risk. NRM will be censored at last follow-up if patients are alive and remain disease free. Will be analyzed using the Kaplan-Meier curves.

  • Incidence of grade 2-4 acute graft versus host disease (GVHD)-free survivalFrom start of HCT to first occurrence of grade 2-4 acute GVHD followed until day +180 or death from any cause, whichever occurs first, assessed up to 1 year post-HCT

    Will be assessed among patients in the safety lead-in and dose expansion segments. Will be estimated using Kaplan-Meier curve.