Acute LeukemiaNCT06803745
Standard-of-Care Reduced-Intensity Conditioning (RIC) With 200 Versus 400 cGy of Total Body Irradiation (TBI) in Patients With Acute Leukemia Undergoing First Allogeneic Blood or Marrow Transplantation (BMT)
A study testing 200 cGy or 400 cGy total body irradiation (TBI) in people with Acute Leukemia and Acute Lymphoblastic Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This is a randomized phase II trial of standard-of-care reduced-intensity conditioning (RIC) with 200 versus 400 cGy of total body irradiation (TBI) in patients with acute leukemia undergoing first allogeneic blood or marrow Transplantation (BMT). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Leukemia, Acute Lymphoblastic Lymphoma
- What is being tested?
- 200 cGy or 400 cGy total body irradiation (TBI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2025to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 0 years
- Patients with a diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia or lymphoma (ALL), or acute leukemia of mixed or ambiguous lineage per the 2022 World Health Organization classifications,75,76 with < 5% blasts on bone marrow morphologic analysis performed within 30 days of planned conditioning initiation
- AML is generally defined as ≥ 20% myeloid blasts identified in the peripheral blood and/or bone marrow. Myeloid sarcoma is also recognized as an AML-defining entity. Situations in which AML can be diagnosed without a specific blast threshold met nor myeloid sarcoma present are when fusions involving RUNX1::RUNX1T1, CBFB::MYH11, DEK:NUP214, or RBM15::MRTFA are present; rearrangements involving KMT2A, MECOM, or NUP98 exist; or there is a mutation in NPM1.
- B- or T-ALL is defined as the presence of lymphoid blasts identified in the peripheral blood and/or bone marrow with no specific blast threshold needed (acute lymphoblastic leukemia) or the presence of a lymphatic-based collection of lymphoblasts (acute lymphoblastic lymphoma).
- Acute leukemia of mixed or ambiguous lineage is defined as mixed or ambiguous lineage blasts identified in the peripheral blood and/or bone marrow or the presence of a lymphatic-based collection (lymphoma) of mixed or ambiguous lineage blasts. A specific blast threshold does not need to be met.
- Patients with a documented diagnosis of myeloproliferative neoplasm (MPN), myelodysplastic syndrome or neoplasm (MDS), and/or MDS/MPN-overlap prior to diagnosis of acute leukemia may be included for randomization in this clinical trial so long as the patient has received at least 4 cycles of DNA methyltransferase inhibitor (e.g., azacitidine, decitabine, decitabine/cedazuradine (Inqovi), and/or any other agent that works via this mechanism) or at least one cycle of induction chemotherapy. A list of antecedent diagnoses per the World Health Organization 2022 classification of hematolymphoid tumors that pertain to this inclusion criterion are listed below 75
Show all 22Show fewer
- i. MPN includes myelofibrosis, essential thrombocythemia, polycythemia vera, chronic neutrophilic leukemia, chronic eosinophilic leukemia, juvenile myelomonocytic leukemia, chronic myeloid leukemia (CML), or myeloproliferative neoplasm, not otherwise specified
- ii. Myelodysplastic syndrome or neoplasm (MDS)
- iii. MDS/MPN-overlap includes chronic myelomonocytic leukemia (CMML), myelodysplastic/myeloproliferative neoplasm with neutrophilia, myelodysplastic/myeloproliferative neoplasm with SF3B1 mutation and thrombocytosis, or myelodysplastic/myeloproliferative neoplasm, not otherwise specified
- iv. Of note, patients without a documented history of one of these conditions prior to diagnosis of acute myeloid leukemia with myelodysplastic features would not be restricted to this specific criterion for study inclusion.
- No active extramedullary leukemia or known active Central Nervous System (CNS) involvement by malignancy. Such disease treated into remission is permitted.
- Patients must have a related or unrelated bone marrow or peripheral blood donor
- Human leukocyte antigen (HLA)-matched (10/10) sibling donor (MSD)
- HLA-matched (10/10) unrelated donor (MUD)
- HLA-haploidentical (5/10) related donor (Haplo)
- HLA-mismatched (5-9/10) unrelated donor (mMUD)
- Planned allogeneic BMT using post-transplantation cyclophosphamide (PTCy) as a component of GVHD prophylaxis
- Adequate end-organ function as measured by:
- Left ventricular ejection fraction greater than or equal to 35% or shortening fraction > 25%
- Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x Upper Limit of Normal (ULN)
- Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) > 40% of predicted
- Patients may enroll in other transplant-related trials (e.g., those testing post-transplant maintenance strategies or peri-transplant strategies for the management of donor specific antibodies) as long as other eligibility criteria are met and the requirements do not conflict with the treatment plan as outlined herein. Patients may also receive standard of care post-transplant maintenance therapies.
Who cannot join
- 1) Acute leukemia with promyelocytic leukemia (PML)/retinoic acid receptor α (RARA) fusion 2)2) Documented, clinical diagnosis of myeloproliferative neoplasm (MPN), myelodysplastic syndrome or neoplasm (MDS), and/or MDS/MPN-overlap based on the World Health Organization 2022 classification prior to diagnosis of acute leukemia.75 Patients with a diagnosis of AML with myelodysplastic features based on cytogenetic or genetic features and without an antecedent clinical history of MPN, MDS, and/or MDS/MPN-overlap are not excluded.
- 3) Prior allogeneic BMT 4) Eastern Cooperative Oncology Group (ECOG) Performance Status > 2 or Karnofsky/Lansky score < 60 5) Patients with an additional active malignancy with a life expectancy < 2 years due to that disease 6) Symptomatic coronary artery disease 7) Uncontrolled infection 8) Patients who are pregnant or breastfeeding 9) Body mass index (BMI) > 45 kg/m2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Jonathan Webster, MD, 410-614-9106, jwebst17@jhmi.edu
About this study
Official title: A Randomized Phase II Trial of Standard-of-Care Reduced-Intensity Conditioning (RIC) With 200 Versus 400 cGy of Total Body Irradiation (TBI) in Patients With Acute Leukemia Undergoing First Allogeneic Blood or Marrow Transplantation (BMT)
This is a randomized phase II trial of standard-of-care reduced-intensity conditioning (RIC) with 200 versus 400 cGy of total body irradiation (TBI) in patients with acute leukemia undergoing first allogeneic blood or marrow Transplantation (BMT). The primary objective is to compare the rates of graft-versus-host disease-free and relapse-free survival (GRFS) between patients in the two cohorts.
Read the detailed description
This research is being done to learn more about reduced-intensity conditioning stem cell transplant for patients with acute leukemias or acute lymphoblastic lymphoma, using stem cell donation from the peripheral blood or bone marrow from a relative or an unrelated donor.
The purpose of this study is to determine if a TBI dose of 400 cGy yields better transplant-related outcomes than a TBI dose of 200 cGy when leukemia patients in remission undergo a reduced-intensity conditioning transplant using high-dose post-transplantation cyclophosphamide as GVHD prophylaxis. The study will use graft-versus-host disease-free, relapse-free survival (GRFS) as its primary endpoint. GRFS will be defined as time from transplant to the first of any grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, disease relapse or progression, or death by any cause.
The transplantation of stem cells from the peripheral blood or bone marrow of a related or unrelated donor is a standard, established treatment for both acute leukemias and acute lymphoblastic lymphoma. Possible donors include parents, siblings, and children. The donor may also be unrelated to the patient. In order to help the donor cells grow, standard of care chemotherapy and radiation will be given before the transplant. Standard of care prophylactic immunosuppression will be used and includes the use of post-transplant cyclophosphamide. These medications lower the risk of GVHD and graft rejection. The exact planned duration of prophylactic immunosuppression will be dictated by institutional protocols based on donor type.
Reduced-intensity transplants have been given to many people in the treatment of various cancers. Over 1000 people at Johns Hopkins have received this type of transplant. Standard chemotherapy, commonly fludarabine and cyclophosphamide, along with radiation will be administered before infusion of the cells transplanted from the donor. The radiation administered as part of this pre-transplant conditioning regimen is called total body irradiation (TBI). This is important in allowing the donated stem cells to grow. TBI may also kill residual cancer cells. The optimal dose of TBI is unknown. Very high doses of TBI have been used previously and are associated with some anti-cancer activity but also significant side effects and an increased risk of death. Due to the significant risks associated with high doses of TBI, the practice at Johns Hopkins has been to use lower doses of TBI, either 200 or 400 centiGray (cGy) in one administration. It is unclear which of these doses, 200 or 400 centiGray (cGy), is superior in balancing anti-cancer effects and reducing side effects. The higher dose of TBI may increase the anti-cancer activity and the chance of engraftment, thereby reducing the patient's risk of disease relapse, which can be fatal. The lower dose of TBI may decrease the risk of blood transfusions, infertility, infections, GVHD, second cancers, and death without disease relapse.
The main goal of the study is to see which of these doses of TBI, 200 or 400 cGy, as part of reduced-intensity conditioning before stem cell transplantation, is superior in terms of reducing the combined risk of leukemia relapse, death, and severe GVHD. The study also looks at whether there is a difference in whether the donated stem cells engraft, time to blood count recovery, time admitted to a hospital, new cancers developing after stem cell transplant, overall severe side effects, how many people survive without cancer, and how many people survive overall depending on the dose of radiation received.
Patients will be randomly assigned to receive either 200 or 400 cGy of total body irradiation (TBI) as part of the reduced intensity conditioning regimen before stem cell transplant. This decision will be based a computer system that randomizes people into each group.
The study regimen includes several days of chemotherapy, immunosuppressant, and a single dose of radiation, either 200 or 400 cGy, followed by the bone marrow transplant. After the transplant, patients will receive two doses of the intravenous chemotherapy cyclophosphamide and two oral medications to prevent graft versus host disease and to aid in bone marrow engraftment. Participation on this study will last up to 2 years after transplant.
- Conditions
- Acute Leukemia, Acute Lymphoblastic Lymphoma
- Being tested
- 200 cGy or 400 cGy total body irradiation (TBI)
- Keywords
- stem cell transplant, bone marrow transplant, transplantation conditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 cGy or 400 cGy total body irradiation (TBI)Radiation
Either 200 or 400cGy will be given as part of reduced-intensity conditioning prior to consolidative allogeneic bone marrow transplant (alloBMT)
| Study group | Role | What they receive |
|---|---|---|
| TBI: 200 Centigray (cGy) | Active comparator | 200 cGy TBI is administered based on randomization in a single fraction on Day -3, -2, or -1, depending on if and how many days of rest are permitted.
A day of rest occurring after preparative regimen completion and prior to stem cell infusion, is not routinely scheduled. Up to two days of rest may be added in this window based on logistical considerations or clinically as indicated. For one day of rest, TBI would be administered on Day -2. For two days of rest, TBI would be administered on Day -3. Receives: Radiation: 200 cGy or 400 cGy total body irradiation (TBI) |
| TBI: 400 cGy | Active comparator | 400 cGy TBI is administered based on randomization in a single fraction on Day -3, -2, or -1, depending on if and how many days of rest are permitted.
A day of rest occurring after preparative regimen completion and prior to stem cell infusion, is not routinely scheduled. Up to two days of rest may be added in this window based on logistical considerations or clinically as indicated. For one day of rest, TBI would be administered on Day -2. For two days of rest, TBI would be administered on Day -3. Receives: Radiation: 200 cGy or 400 cGy total body irradiation (TBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft-versus-host disease-free, relapse-free survival (GRFS)
Number of patients without grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, disease relapse or progression, or death by any cause from time of transplant until end of study
Measured: 2 years
Secondary outcomes (8)
Overall survival (OS)
Number of patients surviving from day of transplant until end of study
Measured: 2 years
Relapse-free survival (RFS)
Number of patients who are disease relapse free from time of transplant until end of study
Measured: 2 years
Relapse Incidence
Cumulative incidence of relapse in each treatment arm from time of transplant until end of study
Measured: 2 years
Non-relapsed mortality (NRM)
Number of people who died without disease relapse in each treatment arm from time of transplant until end of study
Measured: 2 years
Graft vs Host Disease (GVHD)- moderate-to-severe chronic GVHD
Number of incidences of moderate-to-severe chronic GVHD from time of transplant until end of study
Measured: 2 years
Graft vs Host Disease (GVHD)- acute grade II-IV
Number of incidences of acute grade II -IV GVHD from time of transplant until end of study
Measured: 2 years
Graft vs Host Disease (GVHD)- grade III-IV
Number of incidences of grade III-IV GVHD from time of transplant until end of study
Measured: 2 years
Graft Failure
Incidence of graft failure from time of transplant until end of study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start27 Mar 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Webster, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803745
- Sponsor's protocol ID
- J24142
- Other IDs
- IRB00479809
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Standard-of-Care Reduced-Intensity Conditioning (RIC) With 200 Versus 400 cGy of Total Body Irradiation (TBI) in Patients With Acute Leukemia Undergoing First Allogeneic Blood or Marrow Transplantation (BMT)
- ClinicalTrials.gov ID
- NCT06803745
- Acronym / sponsor ID
- J24142
- Conditions
- Acute Leukemia, Acute Lymphoblastic Lymphoma
- Keywords
- stem cell transplant, bone marrow transplant, transplantation conditioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 31 Jan 2025 (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.
This is a randomized phase II trial of standard-of-care reduced-intensity conditioning (RIC) with 200 versus 400 cGy of total body irradiation (TBI) in patients with acute leukemia undergoing first allogeneic blood or marrow Transplantation (BMT). The primary objective is to compare the rates of graft-versus-host disease-free and relapse-free survival (GRFS) between patients in the two cohorts.
Detailed description
This research is being done to learn more about reduced-intensity conditioning stem cell transplant for patients with acute leukemias or acute lymphoblastic lymphoma, using stem cell donation from the peripheral blood or bone marrow from a relative or an unrelated donor.
The purpose of this study is to determine if a TBI dose of 400 cGy yields better transplant-related outcomes than a TBI dose of 200 cGy when leukemia patients in remission undergo a reduced-intensity conditioning transplant using high-dose post-transplantation cyclophosphamide as GVHD prophylaxis. The study will use graft-versus-host disease-free, relapse-free survival (GRFS) as its primary endpoint. GRFS will be defined as time from transplant to the first of any grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, disease relapse or progression, or death by any cause.
The transplantation of stem cells from the peripheral blood or bone marrow of a related or unrelated donor is a standard, established treatment for both acute leukemias and acute lymphoblastic lymphoma. Possible donors include parents, siblings, and children. The donor may also be unrelated to the patient. In order to help the donor cells grow, standard of care chemotherapy and radiation will be given before the transplant. Standard of care prophylactic immunosuppression will be used and includes the use of post-transplant cyclophosphamide. These medications lower the risk of GVHD and graft rejection. The exact planned duration of prophylactic immunosuppression will be dictated by institutional protocols based on donor type.
Reduced-intensity transplants have been given to many people in the treatment of various cancers. Over 1000 people at Johns Hopkins have received this type of transplant. Standard chemotherapy, commonly fludarabine and cyclophosphamide, along with radiation will be administered before infusion of the cells transplanted from the donor. The radiation administered as part of this pre-transplant conditioning regimen is called total body irradiation (TBI). This is important in allowing the donated stem cells to grow. TBI may also kill residual cancer cells. The optimal dose of TBI is unknown. Very high doses of TBI have been used previously and are associated with some anti-cancer activity but also significant side effects and an increased risk of death. Due to the significant risks associated with high doses of TBI, the practice at Johns Hopkins has been to use lower doses of TBI, either 200 or 400 centiGray (cGy) in one administration. It is unclear which of these doses, 200 or 400 centiGray (cGy), is superior in balancing anti-cancer effects and reducing side effects. The higher dose of TBI may increase the anti-cancer activity and the chance of engraftment, thereby reducing the patient's risk of disease relapse, which can be fatal. The lower dose of TBI may decrease the risk of blood transfusions, infertility, infections, GVHD, second cancers, and death without disease relapse.
The main goal of the study is to see which of these doses of TBI, 200 or 400 cGy, as part of reduced-intensity conditioning before stem cell transplantation, is superior in terms of reducing the combined risk of leukemia relapse, death, and severe GVHD. The study also looks at whether there is a difference in whether the donated stem cells engraft, time to blood count recovery, time admitted to a hospital, new cancers developing after stem cell transplant, overall severe side effects, how many people survive without cancer, and how many people survive overall depending on the dose of radiation received.
Patients will be randomly assigned to receive either 200 or 400 cGy of total body irradiation (TBI) as part of the reduced intensity conditioning regimen before stem cell transplant. This decision will be based a computer system that randomizes people into each group.
The study regimen includes several days of chemotherapy, immunosuppressant, and a single dose of radiation, either 200 or 400 cGy, followed by the bone marrow transplant. After the transplant, patients will receive two doses of the intravenous chemotherapy cyclophosphamide and two oral medications to prevent graft versus host disease and to aid in bone marrow engraftment. Participation on this study will last up to 2 years after transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI: 200 Centigray (cGy) | Active comparator | Radiation: 200 cGy or 400 cGy total body irradiation (TBI)200 cGy TBI is administered based on randomization in a single fraction on Day -3, -2, or -1, depending on if and how many days of rest are permitted. A day of rest occurring after preparative regimen completion and prior to stem cell infusion, is not routinely scheduled. Up to two days of rest may be added in this window based on logistical considerations or clinically as indicated. For one day of rest, TBI would be administered on Day -2. For two days of rest, TBI would be administered on Day -3. |
| TBI: 400 cGy | Active comparator | Radiation: 200 cGy or 400 cGy total body irradiation (TBI)400 cGy TBI is administered based on randomization in a single fraction on Day -3, -2, or -1, depending on if and how many days of rest are permitted. A day of rest occurring after preparative regimen completion and prior to stem cell infusion, is not routinely scheduled. Up to two days of rest may be added in this window based on logistical considerations or clinically as indicated. For one day of rest, TBI would be administered on Day -2. For two days of rest, TBI would be administered on Day -3. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥ 0 years
- Patients with a diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia or lymphoma (ALL), or acute leukemia of mixed or ambiguous lineage per the 2022 World Health Organization classifications,75,76 with < 5% blasts on bone marrow morphologic analysis performed within 30 days of planned conditioning initiation
- No active extramedullary leukemia or known active Central Nervous System (CNS) involvement by malignancy. Such disease treated into remission is permitted.
- Patients must have a related or unrelated bone marrow or peripheral blood donor
- Planned allogeneic BMT using post-transplantation cyclophosphamide (PTCy) as a component of GVHD prophylaxis
Key exclusion criteria (2 listed)
- 1) Acute leukemia with promyelocytic leukemia (PML)/retinoic acid receptor α (RARA) fusion 2)2) Documented, clinical diagnosis of myeloproliferative neoplasm (MPN), myelodysplastic syndrome or neoplasm (MDS), and/or MDS/MPN-overlap based on the World Health Organization 2022 classification prior to diagnosis of acute leukemia.75 Patients with a diagnosis of AML with myelodysplastic features based on cytogenetic or genetic features and without an antecedent clinical history of MPN, MDS, and/or MDS/MPN-overlap are not excluded.
- 3) Prior allogeneic BMT 4) Eastern Cooperative Oncology Group (ECOG) Performance Status > 2 or Karnofsky/Lansky score < 60 5) Patients with an additional active malignancy with a life expectancy < 2 years due to that disease 6) Symptomatic coronary artery disease 7) Uncontrolled infection 8) Patients who are pregnant or breastfeeding 9) Body mass index (BMI) > 45 kg/m2
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 |
|---|---|---|
| 200 cGy or 400 cGy total body irradiation (TBI)Either 200 or 400cGy will be given as part of reduced-intensity conditioning prior to consolidative allogeneic bone marrow transplant (alloBMT) | Radiation | TBI: 200 Centigray (cGy), TBI: 400 cGy |
Primary outcome
graft-versus-host disease-free, relapse-free survival (GRFS)
Time frame: 2 years
Number of patients without grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, disease relapse or progression, or death by any cause from time of transplant until end of study
8 secondary outcomes
Overall survival (OS)
Time frame: 2 years
Relapse-free survival (RFS)
Time frame: 2 years
Relapse Incidence
Time frame: 2 years
Non-relapsed mortality (NRM)
Time frame: 2 years
Graft vs Host Disease (GVHD)- moderate-to-severe chronic GVHD
Time frame: 2 years
Graft vs Host Disease (GVHD)- acute grade II-IV
Time frame: 2 years
Graft vs Host Disease (GVHD)- grade III-IV
Time frame: 2 years
Graft Failure
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Jonathan Webster principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 200 cGy or 400 cGy total body irradiation (TBI) in people with Acute Leukemia and Acute Lymphoblastic Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 2 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: looking for participants now, as of the sponsor's last update on 6 Apr 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Webster, MD (410-614-9106, jwebst17@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft-versus-host disease-free, relapse-free survival (GRFS) (time frame: 2 years). 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 6 Apr 2026.