Hematologic MalignancyPhase 2NCT05579769
Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.
A Phase 2 study testing Ruxolitinib, Mesna and Anti-thymocyte globulin (ATG) in people with Hematologic Malignancy and Myeloid Malignancy, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The participants are being asked to take part in this clinical trial because the participant have a lymphoid or myeloid based cancer diagnosis that requires a bone marrow transplant. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hematologic Malignancy, Myeloid Malignancy
- What is being tested?
- Ruxolitinib, Mesna and Anti-thymocyte globulin (ATG)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 8 May 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis:
- Patients with high risk acute lymphoblastic leukemia in first remission. Examples include, but are not limited to, patients with certain leukemic cell cytogenetic findings (e.g. t(9;22) or t(4;11)); delayed response to induction chemotherapy; re-emergence of leukemic blasts by MRD (at any level) in patients previously MRD negative; persistently detectable MRD at lower levels; early T-cell precursor (ETP) ALL.
- Patients with acute lymphoblastic leukemia beyond first remission.
- Patients with Hodgkin's disease beyond first remission or with refractory disease.
- Patients with chronic myelogenous leukemia.
- Patients with primary or secondary myelodysplastic syndrome.
Show all 22Show fewer
- Patients with Non-Hodgkin's lymphoma beyond first remission or with refractory disease.
- Patients with de novo acute myeloid leukemia in or beyond first remission or with relapsed or refractory disease, or myeloid sarcoma (extra-medullary AML).
- Patients with secondary acute myeloid leukemia.
- NK cell lymphoblastic leukemia in any CR.
- Biphenotypic, bilineage, or undifferentiated leukemia.
- Juvenile Myelomonocytic Leukemia (JMML)
- All patients with prior evidence of CNS leukemia must be treated and be in CNS CR.
- Patients must have a related or unrelated donor matched at 12 of 12 HLA alleles.
- Patient must have a Karnofsky/Lansky score of 70 or higher.
- Patients must be 12 years of age or older.
- Patients must have a shortening fraction >26% or left ventricular ejection fraction >40%.
- Patients must have bilirubin less than or equal to 2.5 mg/dL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal.
- Patients must have creatinine clearance, or a glomerular filtration rate (GFR), greater than 70 mL/min/1.73m2.
- Patients must be free of severe infection that upon determination of principal investigator precludes BMT.
- Patients must have FVC >50% predicted OR, if unable to perform pulmonary function testing, must maintain pulse oximetry oxygen saturation >92% on room air.
- Female patients of childbearing age must have a negative pregnancy test.
Who cannot join
- Patients who have undergone prior HCT.
- Patients who have a peripheral blood stem cell graft source.
- Patients who have a non-permissive mismatch at the DPB1 allele.
- Patients who are HIV positive.
- Patients positive for Hepatitis B surface antigen (HBsAg).
- Patients positive for Hepatitis C.
- Patients with latent tuberculosis with positive TB IFN gamma release assay.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies
The participants are being asked to take part in this clinical trial because the participant have a lymphoid or myeloid based cancer diagnosis that requires a bone marrow transplant.
Primary Objectives
Read more
To estimate the incidence of severe acute GVHD (saGVHD) using a prophylaxis regimen with no calcineurin inhibitors after day +60 post first allogeneic Human Leukocyte antigen (HLA)-matched sibling or unrelated donor HCT for hematological malignancies.
Secondary objective
Determine the cumulative incidence of relapse, NRM, chronic GVHD, and OS in study participants at one year post-transplant.
Exploratory objectives
- To evaluate the pharmacokinetic/pharmacodynamic (PK/PD) profiles of ruxolitinib, fludarabine, and rATG.
- To assess immune reconstitution in study participants within the first year post-HCT.
Read the detailed description
The investigator propose to employ two preparative regimens based on the underlying hematological malignancy. For hematological malignancies of the lymphoid lineage we will use a standard preparative regimen consisting of Total Body Irradiation and cyclophosphamide (TBI/Cy), unless TBI is contraindicated. For myeloid malignancies we will use thiotepa, busulfan, and fludarabine (TBF), a preparative regimen that has been associated with a reduced risk of relapse and trend for improved survival with comparable NRM in comparison to busulfan and cyclophosphamide (BuCy), our current regimen. All HCT recipients will receive cyclosporine in combination with methotrexate and ruxolitinib as GVHD prophylaxis. Recipients of MUD HCT will receive rATG for additional immunosuppression as is standard for unrelated donor transplants
- Conditions
- Hematologic Malignancy, Myeloid Malignancy
- Being tested
- Ruxolitinib, Mesna, Anti-thymocyte globulin (ATG), Cyclosporine, Cyclophosphamide
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called (Jakafi®)
Day +40 Dosage and Route of Administration-Ruxolitinib tablets should be administered orally BID, approximately every 12 hours, continuously, Oral
MesnaDrug
Also called (Mesnex)
Days -3 and -2 Dosage and Route of Administration-Mesna is dosed based on the cyclophosphamide dose and generally administered in fractionated doses at approximately 20% of the total cyclophosphamide dose, Intravenous.
Anti-thymocyte globulin (ATG)Drug
Also called (Thymoglobulin®, rabbit ATG)
Days -3, -2 and -1 Dosage and Route of Administration-(7 mg/kg total dose); intravenous.
CyclosporineDrug
Also called (Gengraf)
Day -1 Dosage and Route of Administration-3 mg/kg; dose will be adjusted to maintain a steady concentration between 250-350 ng/mL or trough concentration between 175-250 ng/mL when transitioned to intermittent dosing.
CyclophosphamideDrug
Also called (Cytoxan)
Days -3 and -2 Dosage and Route of Administration-60 mg/kg for 2 consecutive days, (120 mg/kg total dose); intravenous.
FludarabineDrug
Also called (Fludara)
Days -4, -3 and -2 Dosage and Route of Administration-50 mg/m2 daily for 3 consecutive days (150 mg/m2 total dose) intravenous
MethotrexateDrug
Also called MTX, Amethopterin
Days +1, +3, +6 and +11 Dosage and Route of Administration-10 mg/m2/dose, intravenous
Total Body Irradiation (radiation treatment)Radiation
Also called TBI
Days -7, -6, -5 and -4 6.2.3 Target Dose 1200 cGy total dose delivered 150 cGy per treatment fraction delivered BID over 4 days with 6 MV photons.
Dose rate should be < 10 cGy/min in patients treated at extended SSD (450-500 cm) in the TBI couch and will be less than 15 cGy/min in young children and infants treated at extended SSD (200-220 cm) on the floor.
Intra-fraction interval should be 6 hours. Custom posteriorly placed (PA only) partial transmission lung shields (blocks) will be used to reduce the average dose to the lung to approximately 1000 cGy total dose.
An additional 400 cGy supplemental testicular radiation delivered in 2 fractions of 200 cGy delivered for males with lymphoid lineage leukemia.
Bone marrow infusionDrug
Day 0
BusulfanDrug
Also called Busulfex)
Days -4, -3 and -2 Dosage and Route of Administration-3.2 mg/kg/day; intravenous.
ThiotepaDrug
Also called Triplex by Immunex, TESPA, TSPA
Days -6 and -5 Dosage and Route of Administration-(10 mg/kg total dose); intravenous
| Study group | Role | What they receive |
|---|---|---|
| Transplant Patients | Experimental | Not described Receives: Drug: Ruxolitinib; Drug: Mesna; Drug: Anti-thymocyte globulin (ATG); Drug: Cyclosporine; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Methotrexate; Radiation: Total Body Irradiation (radiation treatment); Drug: Bone marrow infusion; Drug: Busulfan; Drug: Thiotepa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of saGVHD Using a ProphylaxisRegimen With no Calcineurin Inhibitors After Day 100 Post First Allogeneic HLA-Matched Sibling or Unrelated Donor HCT for Hematological Malignancies.
Development of Severe Acute GVHD (saGVHD) at or before Day 100 post transplant is considered as an event. Severe acute GVHD is defined as grade II-IVGVHD. Acute graft-vs-host disease will be evaluated using the standard grading criteria.
Measured: 100 days post transplant
Secondary outcomes (4)
Cumulative Incidence of Overall Survival (OS)
The one-year survival is defined by the participant who has not died within one year after post transplantation. The rate is calculated by computing the ratio between total number of one year survival patients and the total number of patients.
Measured: One-year post-transplantation.
Cumulative Incidence of Relapse
Bone marrow studies for disease status evaluation will be performed at 1-year post-transplant. Testing will include a research evaluation for minimal residual disease.
Measured: One-year post-transplantation.
Cumulative Incidence of Non Relapse Mortality (NRM)
Non-relapse mortality is death without evidence of disease relapse or progression. The rate is calculated by computing the ratio between total number of NRM patients and the total number of patients.
Measured: One-year post-transplantation.
Cumulative Incidence of Chronic GVHD
Chronic graft-vs-host disease will be evaluated using the standard grading criteria.
Measured: One-year post-transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start14 Mar 2023
- Primary completion8 May 2024
- Study completion8 May 2024
Why it stopped: Principal Investigator left institution
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.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashok Srinivasan, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579769
- Sponsor's protocol ID
- CNI60
- Status last verified
- Sep 2025
- First submitted
- 11 Oct 2022
- Last updated
- 2 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05579769
- Acronym / sponsor ID
- CNI60
- Conditions
- Hematologic Malignancy, Myeloid Malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left institution
- Enrolment
- 3 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Posted 2 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The participants are being asked to take part in this clinical trial because the participant have a lymphoid or myeloid based cancer diagnosis that requires a bone marrow transplant.
Primary Objectives
To estimate the incidence of severe acute GVHD (saGVHD) using a prophylaxis regimen with no calcineurin inhibitors after day +60 post first allogeneic Human Leukocyte antigen (HLA)-matched sibling or unrelated donor HCT for hematological malignancies.
Secondary objective
Determine the cumulative incidence of relapse, NRM, chronic GVHD, and OS in study participants at one year post-transplant.
Exploratory objectives
- To evaluate the pharmacokinetic/pharmacodynamic (PK/PD) profiles of ruxolitinib, fludarabine, and rATG.
- To assess immune reconstitution in study participants within the first year post-HCT.
Detailed description
The investigator propose to employ two preparative regimens based on the underlying hematological malignancy. For hematological malignancies of the lymphoid lineage we will use a standard preparative regimen consisting of Total Body Irradiation and cyclophosphamide (TBI/Cy), unless TBI is contraindicated. For myeloid malignancies we will use thiotepa, busulfan, and fludarabine (TBF), a preparative regimen that has been associated with a reduced risk of relapse and trend for improved survival with comparable NRM in comparison to busulfan and cyclophosphamide (BuCy), our current regimen. All HCT recipients will receive cyclosporine in combination with methotrexate and ruxolitinib as GVHD prophylaxis. Recipients of MUD HCT will receive rATG for additional immunosuppression as is standard for unrelated donor transplants
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplant Patients | Experimental | Drug: Ruxolitinib, Drug: Mesna, Drug: Anti-thymocyte globulin (ATG), Drug: Cyclosporine, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Methotrexate, Radiation: Total Body Irradiation (radiation treatment), Drug: Bone marrow infusion, Drug: Busulfan, Drug: Thiotepa |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- Patients with high risk acute lymphoblastic leukemia in first remission. Examples include, but are not limited to, patients with certain leukemic cell cytogenetic findings (e.g. t(9;22) or t(4;11)); delayed response to induction chemotherapy; re-emergence of leukemic blasts by MRD (at any level) in patients previously MRD negative; persistently detectable MRD at lower levels; early T-cell precursor (ETP) ALL.
- Patients with acute lymphoblastic leukemia beyond first remission.
- Patients with Hodgkin's disease beyond first remission or with refractory disease.
- Patients with chronic myelogenous leukemia.
- Patients with primary or secondary myelodysplastic syndrome.
Key exclusion criteria (7 listed)
- Patients who have undergone prior HCT.
- Patients who have a peripheral blood stem cell graft source.
- Patients who have a non-permissive mismatch at the DPB1 allele.
- Patients who are HIV positive.
- Patients positive for Hepatitis B surface antigen (HBsAg).
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 |
|---|---|---|
| RuxolitinibAlso: (Jakafi®)Day +40 Dosage and Route of Administration-Ruxolitinib tablets should be administered orally BID, approximately every 12 hours, continuously, Oral | Drug | Transplant Patients |
| MesnaAlso: (Mesnex)Days -3 and -2 Dosage and Route of Administration-Mesna is dosed based on the cyclophosphamide dose and generally administered in fractionated doses at approximately 20% of the total cyclophosphamide dose, Intravenous. | Drug | Transplant Patients |
| Anti-thymocyte globulin (ATG)Also: (Thymoglobulin®, rabbit ATG)Days -3, -2 and -1 Dosage and Route of Administration-(7 mg/kg total dose); intravenous. | Drug | Transplant Patients |
| CyclosporineAlso: (Gengraf)Day -1 Dosage and Route of Administration-3 mg/kg; dose will be adjusted to maintain a steady concentration between 250-350 ng/mL or trough concentration between 175-250 ng/mL when transitioned to intermittent dosing. | Drug | Transplant Patients |
| CyclophosphamideAlso: (Cytoxan)Days -3 and -2 Dosage and Route of Administration-60 mg/kg for 2 consecutive days, (120 mg/kg total dose); intravenous. | Drug | Transplant Patients |
| FludarabineAlso: (Fludara)Days -4, -3 and -2 Dosage and Route of Administration-50 mg/m2 daily for 3 consecutive days (150 mg/m2 total dose) intravenous | Drug | Transplant Patients |
| MethotrexateAlso: MTX, AmethopterinDays +1, +3, +6 and +11 Dosage and Route of Administration-10 mg/m2/dose, intravenous | Drug | Transplant Patients |
| Total Body Irradiation (radiation treatment)Also: TBIDays -7, -6, -5 and -4 6.2.3 Target Dose 1200 cGy total dose delivered 150 cGy per treatment fraction delivered BID over 4 days with 6 MV photons. Dose rate should be < 10 cGy/min in patients treated at extended SSD (450-500 cm) in the TBI couch and will be less than 15 cGy/min in young children and infants treated at extended SSD (200-220 cm) on the floor. Intra-fraction interval should be 6 hours. Custom posteriorly placed (PA only) partial transmission lung shields (blocks) will be used to reduce the average dose to the lung to approximately 1000 cGy total dose. An additional 400 cGy supplemental testicular radiation delivered in 2 fractions of 200 cGy delivered for males with lymphoid lineage leukemia. | Radiation | Transplant Patients |
| Bone marrow infusionDay 0 | Drug | Transplant Patients |
| BusulfanAlso: Busulfex)Days -4, -3 and -2 Dosage and Route of Administration-3.2 mg/kg/day; intravenous. | Drug | Transplant Patients |
| ThiotepaAlso: Triplex by Immunex, TESPA, TSPADays -6 and -5 Dosage and Route of Administration-(10 mg/kg total dose); intravenous | Drug | Transplant Patients |
Primary outcome
Proportion of saGVHD Using a ProphylaxisRegimen With no Calcineurin Inhibitors After Day 100 Post First Allogeneic HLA-Matched Sibling or Unrelated Donor HCT for Hematological Malignancies.
Time frame: 100 days post transplant
Development of Severe Acute GVHD (saGVHD) at or before Day 100 post transplant is considered as an event. Severe acute GVHD is defined as grade II-IVGVHD. Acute graft-vs-host disease will be evaluated using the standard grading criteria.
4 secondary outcomes
Cumulative Incidence of Overall Survival (OS)
Time frame: One-year post-transplantation.
Cumulative Incidence of Relapse
Time frame: One-year post-transplantation.
Cumulative Incidence of Non Relapse Mortality (NRM)
Time frame: One-year post-transplantation.
Cumulative Incidence of Chronic GVHD
Time frame: One-year post-transplantation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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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.
Ashok Srinivasan, MD principal investigator
St. Jude Children's Research Hospital
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 Ruxolitinib, Mesna and Anti-thymocyte globulin (ATG) in people with Hematologic Malignancy and Myeloid Malignancy, run by St. Jude Children's Research Hospital 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 22 inclusion and 7 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: stopped early, as of the sponsor's last update on 2 Oct 2025. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2025). 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?
Proportion of saGVHD Using a ProphylaxisRegimen With no Calcineurin Inhibitors After Day 100 Post First Allogeneic HLA-Matched Sibling or Unrelated Donor HCT for Hematological Malignancies. (time frame: 100 days post transplant). 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 2 Oct 2025.