Acute Myelogenous LeukemiaPhase 2NCT06680661
ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis
A Phase 2 study testing Cyclophosphamide, Fludarabine and Thiotepa in people with Acute Myelogenous Leukemia and Acute Lymphatic Leukemia, run by Leland Metheny at 1 site in United States.
Trial summary
The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myelogenous Leukemia, Acute Lymphatic Leukemia, Chronic Myelogenous Leukemia
- What is being tested?
- Cyclophosphamide, Fludarabine and Thiotepa
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to 31 Oct 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the following hematologic malignancies:
- Acute myelogenous leukemia (AML): High-risk and intermediate-risk AML including:
- Antecedent hematological disease (e.g., myelodysplasia (MDS))
- Treatment-related leukemia
- Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, complex cytogenetics)
- CR2 or CR3
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- Induction failure or 1st relapse with < 10% blasts in the marrow
- Acute lymphoblastic leukemia (ALL):
- High-risk CR1 including:
- Poor-risk cytogenetics (e.g., Philadelphia chromosome t(9;22)or 11q23 rearrangements)
- Philadelphia chromosome-like ALL
- Presence of minimal disease by flow cytometry after 2 or more cycles of chemotherapy
- No CR within 4 weeks of initial treatment
- Induction failure with < 10% blasts in the marrow
- CR2 or CR3
- Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system or treatment related MDS.
- Bi-phenotypic or mixed-phenotypic acute leukemia in:
- CR.
- Induction failure or 1st relapse with < 10% blasts in the marrow.
- Chronic Myelogenous Leukemia (CML) in second chronic phase after accelerated or blast crisis.
- Chronic Myelomonocytic Leukemia (CMML)
- Hodgkin's Lymphoma that is relapsed or refractory
- Age > or equal to 18 years, < or equal to 70yrs
- KPS > or equal to 80 for Flu/Cy/Thio/TBI; KPS > 60 for Flu/Treo/TBI
- Patients without a suitable HLA-matched related or unrelated donor
- Patient with the following CB units:
- At least two 4-8/8 HLA high resolution matched CB units. Both must have a cell dose of 1.5x107 TNC/kg each and 1.5x105 CD34+/kg
- A minimum of 1 CB unit as back up.
- Concurrent Therapy for Extramedullary Leukemia or CNS Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia, and CNS lymphoma including standard intrathecal chemotherapy and/or radiation therapy will be allowed as clinically indicated. Such treatment may continue until the planned course is completed. Subjects must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement. Maintenance therapy after transplant is allowed.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for 12 months after the last dose of abatacept.
- A woman is considered to be of childbearing potential if she is < 60 years old, postmenarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
- Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures with female partners of reproductive potential, and agreement to refrain from donating sperm, as defined below:
- With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 12 months after the last dose of abatacept. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 12 months after the last dose of abatacept.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Who cannot join
- Patients with inadequate Organ Function as defined by:
- Creatinine clearance < 50ml/min
- Bilirubin > 2X institutional upper limit of normal unless Gilbert syndrome
- AST (SGOT) > 3X institutional upper limit of normal
- ALT (SGPT) > 3X institutional upper limit of normal
- Pulmonary function: DLCOc < 60% normal
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- Cardiac: left ventricular ejection fraction < 50
- Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
- Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
- Presence of donor-specific antibodies against chosen graft source.
- Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) > 5.
- Prior autologous or allogenic stem cell transplant within the preceding 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: ABBA CORD: Double Umbilical Cord Blood Transplants With Abatacept for Graft Versus Host Disease Prophylaxis
The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT.
Participants will:
- Partake in exams, tests, and procedures as part of usual cancer care.
- Partake in conditioning, which is the treatment that is given before a transplant.
- Have a cord blood transplant.
- Partake in radiation following the transplant.
Read the detailed description
Cord blood (CB) is a valuable alternative graft source for patients with hematologic malignancies in need of allogeneic transplantation who lack human leukocyte antigen (HLA)-matched adult donors. In Black, Asian, Hispanic populations, the chance of finding a HLA matched donor is 23%, 41%, and 46%, respectively. CB allows for greater HLA difference between donor and recipient, and increases the availability of donors, and therefore transplant, to these populations. Retrospective analyses and prospective trials demonstrate that recipients of double CB transplant (dCBT) have a grade II-IV acute graft versus host disease (aGVHD) rate of 45-90% and grade III-IV aGVHD rates up to 24%. This high aGVHD rate is likely due to the HLA-disparities between donor and recipient, which also drives a robust graft versus leukemia response8. Anti-thymocyte globin has been used in dCBT to reduce the incidence of aGVHD, but is no longer recommended due to delayed immune-reconstitution of the CB grafts. The ABA2 trial demonstrated efficacy and safety of abatacept as prophylaxis for aGVHD in HLA-mismatched unrelated donors (MMUD), significantly reducing the rate both of grade III-IV aGVHD and grade II-IV aGVHD in 7/8 MMUD when compared to historical controls. Our hypothesis is that abatacept will be safe and effective in reducing aGVHD rates in dCBT.
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphatic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndromes, Myelodysplastic Syndrome Other, Chronic Myelomonocytic Leukemia
- Being tested
- Cyclophosphamide, Fludarabine, Thiotepa, Total Body Irradiation, Double Umbilical Cord Transplant
- Keywords
- Chronic Myelomonocytic Lymphoma, Umbilical Cord Blood Transplant, Double Umbilical Cord Transplant, Cord blood
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Cyclophosphamide (Cy) is one part of the conditioning regimen. 50 mg/kg beginning on day -6.
FludarabineDrug
Fludarabine (Flu) is one part of the conditioning regimen. 150 mg/m2 (30 mg/m2 per day on days -6 to -2)
ThiotepaDrug
Thiotepa (Thio) is one part of the conditioning regimen.10 mg/kg (5 mg/kg per day on days -5 and -4)
Total Body IrradiationRadiation
400 cGy (200 cGy per day on days -2 and -1).
Double Umbilical Cord TransplantBiological
Cord blood is a regulated biologic. Selection of cord blood units will be based on published guidelines.
TacrolimusDrug
Tacrolimus will be administered post transplant. Graft-versus-host disease prophylaxis will consist of tacrolimus and mycophenolate mofetil (MMF), starting on day-5. Tacrolimus will continue at least until day 180 and then be tapered off.
MMF will be administered post transplant. Graft-versus-host disease prophylaxis will consist of tacrolimus and mycophenolate mofetil (MMF), starting on day-5. MMF will continue until day 30.
AbataceptDrug
Abatacept at a dose of 10mg/kg will be given on days T-1, T+5, T+14 and T+28.
| Study group | Role | What they receive |
|---|---|---|
| Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept | Experimental | Cyclophosphamide (Cy), fludarabine (Flu), thiotepa (Thio), and total body irradiation (TBI) is the preparative regimen for Double Umbilical Cord Transplant (dCBT).
Graft-versus-host disease prophylaxis will consist of tacrolimus (Tac) and mycophenolate mofetil (MMF). Abatacept will be administered. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Thiotepa; Radiation: Total Body Irradiation; Biological: Double Umbilical Cord Transplant; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe aGVHD free survival
To assess severe aGVHD (grade III-IV acute GVHD) free survival (SGFS) at T+180.
Measured: 180 days after treatment
Secondary outcomes (23)
Non-relapse mortality
Treatment Related Mortality (TRM) at 1 year is the percentage of patients who expire from treatment related toxicity attributed to transplant up to 1 year after transplant.
Measured: 1 year post transplant
Overall Survival
Overall Survival (OS) at 1 year is the percentage of patients alive at 1 year after transplant.
Measured: 1 year post transplant
Rate of relapse
Relapse incidence at 1 year is the percentage of patients who experience relapse of their hematologic malignancy up to 1 year after transplant.
Measured: 1 year post transplant
Disease free survival
Disease Free Survival at 1 year is the percentage of patients alive and without evidence of hematologic malignancy at 1 year after transplant.
Measured: 1 year post transplant
Incidence of chronic GVHD
Chronic graft versus host disease (cGVHD) 1-year cumulative incidence is the percentage of patients who experienced any cGVHD up to 1 year after transplant.
Measured: 1 year post transplant
Incidence of chronic GVHD
Chronic graft versus host disease (cGVHD) 2-year cumulative incidence is the percentage of patients who experienced any cGVHD up to 2 years after transplant.
Measured: 2 years post transplant
Incidence of chronic GVHD
Chronic graft versus host disease (cGVHD) 3-year cumulative incidence is the percentage of patients who experienced any cGVHD up to 3 years after transplant.
Measured: 3 years post transplant
Rate of Grade III-IV aGVHD
Grade III-IV aGVHD prevalence at T+100 is the percentage of patients who have grade III-IV aGVHD at T+100.
Measured: 100 days after treatment
Rate of Grade II-IV aGVHD
Grade II-IV aGVHD prevenance at T+100 is the percentage of patients who have grade II-IV aGVHD at T+100.
Measured: 100 days after treatment
Rate of Grade III-IV aGVHD
Grade III-IV aGVHD prevalence at T+180 is the percentage of patients who have grade III-IV aGVHD at T+180.
Measured: 180 days after treatment
Rate of Grade II-IV aGVHD
Grade II-IV aGVHD prevalence at T+180 is the percentage of patients who have grade II-IV aGVHD at T+180.
Measured: 180 days after treatment
CMV reactivation rate
The cumulative incidence of CMV reactivation at 1 year is defined as the detection of CMV within any organ by biopsy or within the plasma within the first year of transplant.
Measured: 1 year after transplant
EBV reactivation rate
The cumulative incidence of EBV reactivation at 1 year is defined as the detection of EBV in the plasma or blood less than 1000 copies/ml within the first year of transplant.
Measured: 1 year after treatment
Time to neutrophil engraftment
Neutrophil engraftment will be calculated as the days from transplant where the absolute neutrophil count (ANC) reaches >500cells/ul x 3 days.
Measured: Within first 30 days of transplant
Time to platelet engraftment
Platelet engraftment will be calculated as the days from transplant where the platelet count reaches 20,000 platelets /ul without the need of transfusion of platelets for 7 days.
Measured: Within first 60 days of transplant
Donor chimerism
Donor chimerism rates will drawn at day 100 post transplant.
Measured: Day 100 post transplant
Donor chimerism
Donor chimerism rates will drawn 1 year post transplant.
Measured: 1 year post transplant
Time to taper off tacrolimus
The average time to taper off of tacrolimus will be calculated.
Measured: Within 1 year of transplant
Time to taper off MMF
The average time to taper off of mycophenolate mofetil (MMF) will be calculated.
Measured: Within 90 days of transplant
Assessment of aGVHD biomarker ST2
An assessment of aGVHD biomarker ST2 will occur 7 days post transplant.
Measured: 7 days post transplant
Assessment of aGVHD biomarker ST2
An assessment of aGVHD biomarker ST2 will occur 28 days post-transplant.
Measured: 28 days post transplant
Assessment of aGVHD biomarker REG3α
An assessment of aGVHD biomarker REG3α will occur 7 days post-transplant.
Measured: 7 days post transplant
Assessment of aGVHD biomarker REG3α
An assessment of aGVHD biomarker REG3α will occur 28 days post-transplant.
Measured: 28 days post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start8 Apr 2026
- Primary completion29 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Why it stopped: insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Approximately 20 subjects will be enrolled in this trial: 7 patients will be accrued for the Stage 1. Stage 1 must be complete and the 7th patient reach T+180 prior to enrolling 13 additional patients to Stage 2.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leland Metheny
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leland Metheny, Case Comprehensive Cancer Center
- Investigators
- Leland Metheny, MD, Principal investigator, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680661
- Sponsor's protocol ID
- CASE1924
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in publication.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABBA CORD: Double Umbilical Cord Blood Transplants With Abatacept for Graft Versus Host Disease Prophylaxis
- ClinicalTrials.gov ID
- NCT06680661
- Acronym / sponsor ID
- CASE1924
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphatic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndromes, Myelodysplastic Syndrome Other, Chronic Myelomonocytic Leukemia
- Keywords
- Chronic Myelomonocytic Lymphoma, Umbilical Cord Blood Transplant, Double Umbilical Cord Transplant, Cord blood
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: insufficient funding
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Leland MethenyUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 29 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT.
Participants will:
- Partake in exams, tests, and procedures as part of usual cancer care.
- Partake in conditioning, which is the treatment that is given before a transplant.
- Have a cord blood transplant.
- Partake in radiation following the transplant.
Detailed description
Cord blood (CB) is a valuable alternative graft source for patients with hematologic malignancies in need of allogeneic transplantation who lack human leukocyte antigen (HLA)-matched adult donors. In Black, Asian, Hispanic populations, the chance of finding a HLA matched donor is 23%, 41%, and 46%, respectively. CB allows for greater HLA difference between donor and recipient, and increases the availability of donors, and therefore transplant, to these populations. Retrospective analyses and prospective trials demonstrate that recipients of double CB transplant (dCBT) have a grade II-IV acute graft versus host disease (aGVHD) rate of 45-90% and grade III-IV aGVHD rates up to 24%. This high aGVHD rate is likely due to the HLA-disparities between donor and recipient, which also drives a robust graft versus leukemia response8. Anti-thymocyte globin has been used in dCBT to reduce the incidence of aGVHD, but is no longer recommended due to delayed immune-reconstitution of the CB grafts. The ABA2 trial demonstrated efficacy and safety of abatacept as prophylaxis for aGVHD in HLA-mismatched unrelated donors (MMUD), significantly reducing the rate both of grade III-IV aGVHD and grade II-IV aGVHD in 7/8 MMUD when compared to historical controls. Our hypothesis is that abatacept will be safe and effective in reducing aGVHD rates in dCBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Approximately 20 subjects will be enrolled in this trial: 7 patients will be accrued for the Stage 1. Stage 1 must be complete and the 7th patient reach T+180 prior to enrolling 13 additional patients to Stage 2.
| Arm | Type | Receives |
|---|---|---|
| Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Thiotepa, Radiation: Total Body Irradiation, Biological: Double Umbilical Cord Transplant, Drug: Tacrolimus, Drug: Mycophenolate Mofetil, Drug: AbataceptCyclophosphamide (Cy), fludarabine (Flu), thiotepa (Thio), and total body irradiation (TBI) is the preparative regimen for Double Umbilical Cord Transplant (dCBT). Graft-versus-host disease prophylaxis will consist of tacrolimus (Tac) and mycophenolate mofetil (MMF). Abatacept will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Patients with the following hematologic malignancies:
- Age > or equal to 18 years, < or equal to 70yrs
- KPS > or equal to 80 for Flu/Cy/Thio/TBI; KPS > 60 for Flu/Treo/TBI
- Patients without a suitable HLA-matched related or unrelated donor
- Patient with the following CB units:
Key exclusion criteria (14 listed)
- Patients with inadequate Organ Function as defined by:
- Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
- Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
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 |
|---|---|---|
| CyclophosphamideCyclophosphamide (Cy) is one part of the conditioning regimen. 50 mg/kg beginning on day -6. | Drug | Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept |
| FludarabineFludarabine (Flu) is one part of the conditioning regimen. 150 mg/m2 (30 mg/m2 per day on days -6 to -2) | Drug | Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept |
| ThiotepaThiotepa (Thio) is one part of the conditioning regimen.10 mg/kg (5 mg/kg per day on days -5 and -4) | Drug | Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept |
| Total Body Irradiation400 cGy (200 cGy per day on days -2 and -1). | Radiation | Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept |
| Double Umbilical Cord TransplantCord blood is a regulated biologic. Selection of cord blood units will be based on published guidelines. | Biological | Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept |
| TacrolimusTacrolimus will be administered post transplant. Graft-versus-host disease prophylaxis will consist of tacrolimus and mycophenolate mofetil (MMF), starting on day-5. Tacrolimus will continue at least until day 180 and then be tapered off. | Drug | Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept |
| Mycophenolate MofetilMMF will be administered post transplant. Graft-versus-host disease prophylaxis will consist of tacrolimus and mycophenolate mofetil (MMF), starting on day-5. MMF will continue until day 30. | Drug | Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept |
| AbataceptAbatacept at a dose of 10mg/kg will be given on days T-1, T+5, T+14 and T+28. | Drug | Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept |
Primary outcome
Severe aGVHD free survival
Time frame: 180 days after treatment
To assess severe aGVHD (grade III-IV acute GVHD) free survival (SGFS) at T+180.
23 secondary outcomes
Non-relapse mortality
Time frame: 1 year post transplant
Overall Survival
Time frame: 1 year post transplant
Rate of relapse
Time frame: 1 year post transplant
Disease free survival
Time frame: 1 year post transplant
Incidence of chronic GVHD
Time frame: 1 year post transplant
Incidence of chronic GVHD
Time frame: 2 years post transplant
Incidence of chronic GVHD
Time frame: 3 years post transplant
Rate of Grade III-IV aGVHD
Time frame: 100 days after treatment
Rate of Grade II-IV aGVHD
Time frame: 100 days after treatment
Rate of Grade III-IV aGVHD
Time frame: 180 days after treatment
Rate of Grade II-IV aGVHD
Time frame: 180 days after treatment
CMV reactivation rate
Time frame: 1 year after transplant
EBV reactivation rate
Time frame: 1 year after treatment
Time to neutrophil engraftment
Time frame: Within first 30 days of transplant
Time to platelet engraftment
Time frame: Within first 60 days of transplant
Donor chimerism
Time frame: Day 100 post transplant
Donor chimerism
Time frame: 1 year post transplant
Time to taper off tacrolimus
Time frame: Within 1 year of transplant
Time to taper off MMF
Time frame: Within 90 days of transplant
Assessment of aGVHD biomarker ST2
Time frame: 7 days post transplant
Assessment of aGVHD biomarker ST2
Time frame: 28 days post transplant
Assessment of aGVHD biomarker REG3α
Time frame: 7 days post transplant
Assessment of aGVHD biomarker REG3α
Time frame: 28 days post transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in publication.
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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.
Leland Metheny, MD principal investigator
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Fludarabine and Thiotepa in people with Acute Myelogenous Leukemia and Acute Lymphatic Leukemia, run by Leland Metheny at 1 site 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 37 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: paused, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
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?
Severe aGVHD free survival (time frame: 180 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.