T-cell LymphomaPhase 2NCT07356245
Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma
A Phase 2 study testing Ruxolitinib, Positron emission tomography-computed tomography and Bone Marrow Biopsy in people with T-cell Lymphoma and Graft Versus Host Disease, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-cell Lymphoma, Graft Versus Host Disease, Lymphoma, T-Cell
- What is being tested?
- Ruxolitinib, Positron emission tomography-computed tomography and Bone Marrow Biopsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2026to 31 Oct 2027
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with T-cell lymphoma [PTCL (all subtypes), T-PLL, ATLL, and CTCL (all subtypes)] in partial or complete remission between day +35 and +120 from auto-SCT or allo-SCT
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate hematologic function defined by absolute neutrophil count (ANC) > 1000/mm3 without granulocyte colony-stimulating factor (G-CSF) for at least 3 days, platelets > 50K/mm3 without transfusion for at least 3 days and hemoglobin (Hb) > 8.0 g/dL without transfusion for at least 3 days.
- Adequate organ function defined by total Bilirubin < 1.5 x ULN, alanine aminotransferase (ALT) </= 3 x ULN, CKD-EPI eGFR ≥ 30 ml/min, SpO2 > 92% without supplemental oxygen.
- Chimerism testing within 30 days of screening that shows >90% CD3 and >90% CD33 (for allo-SCT only).[
- Able to tolerate oral or enteral medications.
- Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Able to read and sign informed consent.
Who cannot join
- Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (<2) in first complete remission.
- Progressive disease or any other systemic therapy post-SCT (radiation allowed)
- Disease progression to Ruxolitinib previously
- GvHD requiring systemic therapy.
- Active uncontrolled infections.
- Active thrombotic active microangiopathy requiring therapy.
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- History of veno-occlusive disorder post-transplant
- Use of platelets antiaggregant or anticoagulants deemed to be unsafe to be held in case of thrombocytopenia.
- History of life-threatening bleeding defined as any bleeding that required invasive procedures or involving central nervous system.
- Pregnancy (positive Beta HCG test in a woman with childbearing potential defined as not postmenopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Uncontrolled Hepatitis B/C, HIV, tuberculosis, mycobacterium, or fungal infection.
- Exposure to other investigational drugs within 4 weeks before enrollment.
- Grade ≥ 3 non-hematologic toxicity from SCT that has not resolved to grade ≤ 2.
- Myocardial infarction or stroke within 1 year of study entry.
- Any uncontrolled medical problem at the discretion of the investigator that would pose a risk to the patient.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States2 sites, 2 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Jonathan Brammer, MD, Jonathan.Brammer@osumc.edu
Jonathan Brammer, MD
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
Clinical Trial Registration Help Lines, 713-792-7734, CR_Study_Registration@MDAnderson.org
Chitra Hosing, MD
About this study
Official title: Phase II Study of Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant in T-Cell Lymphoma
This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The "graft" is the donor blood cells that patients get during the transplant. The "host" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the effect of ruxolitinib phosphate (ruxolitinib) on relapse at 1-year after autologous (auto) stem cell transplant (SCT) in T-cell lymphoma (TCL).
II. Determine the effect of ruxolitinib on graft versus host disease (GvHD) and relapse free-survival (GRFS) at 1-year for allogeneic (allo) SCT in TCL.
SECONDARY OBJECTIVES:
PRIMARY OBJECTIVES:
- Determine the effect of ruxolitinib phosphate (ruxolitinib) on relapse at 1-year after autologous (auto) stem cell transplant (SCT) in T-cell lymphoma (TCL).
II. Determine the effect of ruxolitinib on graft versus host disease (GvHD) and relapse free-survival (GRFS) at 1-year for allogeneic (allo) SCT in TCL.
SECONDARY OBJECTIVES:
- Survival (progression free survival [PFS]/overall survival [OS]) of patients with ruxolitinib maintenance (auto-SCT, allo-SCT, whole cohort).
II. Determine the safety and feasibility of ruxolitinib maintenance post-SCT. III. Determine the effect of ruxolitinib on the cumulative incidence (CI) of grade II-IV acute GVHD (alloSCT), chronic extensive GVHD, non-relapse mortality (NRM) (auto-SCT and allo-SCT).
EXPLORATORY OBJECTIVES:
- Determine the effect of maintenance ruxolitinib compared to matched historical controls using the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.
II. Determine the effect of ruxolitinib on immune modulation and reconstitution post-allo-SCT and upon disease relapse.
OUTLINE:
Starting day +35 to day +120 post-SCT, patients receive ruxolitinib orally (PO) twice daily (BID) on days 1-30 of each cycle. Cycles repeat every 30 days for 1 year post-SCT, in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET)-computed tomography (CT) scan and blood sample collection throughout the study. Patients may undergo bone marrow biopsy and/or tissue biopsy throughout the study, at time of progression.
After completion of study treatment, patients are followed up at 18 and 24 months then yearly until 5 years and at progression.
- Conditions
- T-cell Lymphoma, Graft Versus Host Disease, Lymphoma, T-Cell, Peripheral T Cell Lymphoma, T-cell Prolymphocytic Leukemia, Cutaneous T Cell Lymphoma
- Being tested
- Ruxolitinib, Positron emission tomography-computed tomography, Bone Marrow Biopsy, Biopsy Procedure, Biospecimen Collection
- Keywords
- stem cell transplant, graft versus host disease, lymphoma, leukemia
- Medical subject headings
- Lymphoma, T-Cell, Graft vs Host Disease, Lymphoma, T-Cell, Peripheral, Leukemia, Prolymphocytic, T-Cell, Lymphoma, T-Cell, Cutaneous, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Administered orally twice daily
Positron emission tomography-computed tomographyProcedure or surgery
Also called PET-CT, PET-CT Scan, Computed tomography
Undergo PET-CT Scan
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy
Undergo bone marrow biopsy
Biopsy ProcedureProcedure or surgery
Also called Biopsy
Undergo tissue biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological sampe collection, Biospecimen Collected, Speciment collection
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ruxolitinib maintenance) | Experimental | Starting day +35 to day +120 post-SCT, patients receive ruxolitinib PO BID on days 1-30 of each cycle. Cycles repeat every 30 days for 1 year post-SCT, in the absence of disease progression or unacceptable toxicity. Patients undergo PET-CT scan and blood sample collection throughout the study. Patients may undergo bone marrow biopsy and/or tissue biopsy throughout the study, at time of progression. Receives: Drug: Ruxolitinib; Procedure: Positron emission tomography-computed tomography; Procedure: Bone Marrow Biopsy; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence (CI) of relapse
Relapse is defined as evidence of disease progression or recurrence based on Lugano criteria or confirmed by biopsy.
Measured: at 1-year post-auto-SCT
GvHD and relapse free-survival (GRFS)
GRFS is a composite endpoint of survival without grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD (cGVHD), relapse, or death. Will be evaluated using the Kaplan-Meier method, with median survival and probability of surviving to relevant time points reported with point estimates and 90% confidence intervals separately for each study cohort. Comparisons to Center for International Blood and Marrow Transplant Research (CIBMTR) patients will use log-rank tests.
Measured: at 1-year post-allo-SCT
Secondary outcomes (7)
Progression-Free survival (PFS)
Will be evaluated using the Kaplan-Meier method, with median survival and probability of surviving to relevant time points reported with point estimates and 90% confidence intervals separately for each study cohort. Comparisons to CIBMTR patients will use log-rank tests
Measured: At 1 and 2 years
Overall Survival (OS)
Will be evaluated using the Kaplan-Meier method, with median survival and probability of surviving to relevant time points reported with point estimates and 90% confidence intervals separately for each study cohort. Comparisons to CIBMTR patients will use log-rank tests.
Measured: At 1 and 2 years
Cumulative incidence of grade II-IV acute GVHD (allo-SCT cohort)
Will be conducted using non-relapse mortality (NRM) as a competing risk, with estimates of cumulative incidence at various time points reported with 90% confidence intervals. Cumulative incidences will be compared to CIBMTR data using Fine-Gray analysis.
Measured: Up to 5 years
Cumulative incidence of chronic extensive GvHD (allo-SCT cohort)
Will be conducted using NRM as a competing risk, with estimates of cumulative incidence at various time points reported with 90% confidence intervals. Cumulative incidences will be compared to CIBMTR data using Fine-Gray analysis.
Measured: at 1 year post-SCT
Cumulative Incidence of non-relapse mortality (NRM) at 1-year after (auto-SCT, allo-SCT, whole cohort)
Will be conducted using NRM as a competing risk, with estimates of cumulative incidence at various time points reported with 90% confidence intervals. Cumulative incidences will be compared to CIBMTR data using Fine-Gray analysis
Measured: At 1 year
Rates of grade 3-4 treatment Emergent Adverse Events
Treatment-emergent adverse events of grade 3 and higher will also be reported for each cohort
Measured: Up to 2 years
Rate of patients completing 1-year post-SCT maintenance Ruxolitinib
Will be conducted using NRM as a competing risk, with estimates of cumulative incidence at various time points reported with 90% confidence intervals. Cumulative incidences will be compared to CIBMTR data using Fine-Gray analysis
Measured: At 1 year post-SCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start12 Feb 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- 44 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Principal investigator, Zachary Braunstein, Ohio State University Comprehensive Cancer Center
- Investigators
- Jonathan Brammer, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356245
- Sponsor's protocol ID
- OSU-24353
- Other IDs
- NCI-2026-00140
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant in T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07356245
- Acronym / sponsor ID
- OSU-24353
- Conditions
- T-cell Lymphoma, Graft Versus Host Disease, Lymphoma, T-Cell, Peripheral T Cell Lymphoma, T-cell Prolymphocytic Leukemia, Cutaneous T Cell Lymphoma
- Keywords
- stem cell transplant, graft versus host disease, lymphoma, leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 21 Jan 2026 (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 phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The "graft" is the donor blood cells that patients get during the transplant. The "host" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.
Detailed description
PRIMARY OBJECTIVES:
- Determine the effect of ruxolitinib phosphate (ruxolitinib) on relapse at 1-year after autologous (auto) stem cell transplant (SCT) in T-cell lymphoma (TCL).
II. Determine the effect of ruxolitinib on graft versus host disease (GvHD) and relapse free-survival (GRFS) at 1-year for allogeneic (allo) SCT in TCL.
SECONDARY OBJECTIVES:
PRIMARY OBJECTIVES:
- Determine the effect of ruxolitinib phosphate (ruxolitinib) on relapse at 1-year after autologous (auto) stem cell transplant (SCT) in T-cell lymphoma (TCL).
II. Determine the effect of ruxolitinib on graft versus host disease (GvHD) and relapse free-survival (GRFS) at 1-year for allogeneic (allo) SCT in TCL.
SECONDARY OBJECTIVES:
- Survival (progression free survival [PFS]/overall survival [OS]) of patients with ruxolitinib maintenance (auto-SCT, allo-SCT, whole cohort).
II. Determine the safety and feasibility of ruxolitinib maintenance post-SCT. III. Determine the effect of ruxolitinib on the cumulative incidence (CI) of grade II-IV acute GVHD (alloSCT), chronic extensive GVHD, non-relapse mortality (NRM) (auto-SCT and allo-SCT).
EXPLORATORY OBJECTIVES:
- Determine the effect of maintenance ruxolitinib compared to matched historical controls using the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.
II. Determine the effect of ruxolitinib on immune modulation and reconstitution post-allo-SCT and upon disease relapse.
OUTLINE:
Starting day +35 to day +120 post-SCT, patients receive ruxolitinib orally (PO) twice daily (BID) on days 1-30 of each cycle. Cycles repeat every 30 days for 1 year post-SCT, in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET)-computed tomography (CT) scan and blood sample collection throughout the study. Patients may undergo bone marrow biopsy and/or tissue biopsy throughout the study, at time of progression.
After completion of study treatment, patients are followed up at 18 and 24 months then yearly until 5 years and at progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ruxolitinib maintenance) | Experimental | Drug: Ruxolitinib, Procedure: Positron emission tomography-computed tomography, Procedure: Bone Marrow Biopsy, Procedure: Biopsy Procedure, Procedure: Biospecimen CollectionStarting day +35 to day +120 post-SCT, patients receive ruxolitinib PO BID on days 1-30 of each cycle. Cycles repeat every 30 days for 1 year post-SCT, in the absence of disease progression or unacceptable toxicity. Patients undergo PET-CT scan and blood sample collection throughout the study. Patients may undergo bone marrow biopsy and/or tissue biopsy throughout the study, at time of progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients with T-cell lymphoma [PTCL (all subtypes), T-PLL, ATLL, and CTCL (all subtypes)] in partial or complete remission between day +35 and +120 from auto-SCT or allo-SCT
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate hematologic function defined by absolute neutrophil count (ANC) > 1000/mm3 without granulocyte colony-stimulating factor (G-CSF) for at least 3 days, platelets > 50K/mm3 without transfusion for at least 3 days and hemoglobin (Hb) > 8.0 g/dL without transfusion for at least 3 days.
- Adequate organ function defined by total Bilirubin < 1.5 x ULN, alanine aminotransferase (ALT) </= 3 x ULN, CKD-EPI eGFR ≥ 30 ml/min, SpO2 > 92% without supplemental oxygen.
- Chimerism testing within 30 days of screening that shows >90% CD3 and >90% CD33 (for allo-SCT only).[
Key exclusion criteria (15 listed)
- Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (<2) in first complete remission.
- Progressive disease or any other systemic therapy post-SCT (radiation allowed)
- Disease progression to Ruxolitinib previously
- GvHD requiring systemic therapy.
- Active uncontrolled infections.
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 |
|---|---|---|
| RuxolitinibAdministered orally twice daily | Drug | Treatment (ruxolitinib maintenance) |
| Positron emission tomography-computed tomographyAlso: PET-CT, PET-CT Scan, Computed tomographyUndergo PET-CT Scan | Procedure or surgery | Treatment (ruxolitinib maintenance) |
| Bone Marrow BiopsyAlso: Biopsy of Bone Marrow, BiopsyUndergo bone marrow biopsy | Procedure or surgery | Treatment (ruxolitinib maintenance) |
| Biopsy ProcedureAlso: BiopsyUndergo tissue biopsy | Procedure or surgery | Treatment (ruxolitinib maintenance) |
| Biospecimen CollectionAlso: Biological sampe collection, Biospecimen Collected, Speciment collectionUndergo blood sample collection | Procedure or surgery | Treatment (ruxolitinib maintenance) |
Primary outcome
Cumulative Incidence (CI) of relapse
Time frame: at 1-year post-auto-SCT
Relapse is defined as evidence of disease progression or recurrence based on Lugano criteria or confirmed by biopsy.
GvHD and relapse free-survival (GRFS)
Time frame: at 1-year post-allo-SCT
GRFS is a composite endpoint of survival without grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD (cGVHD), relapse, or death. Will be evaluated using the Kaplan-Meier method, with median survival and probability of surviving to relevant time points reported with point estimates and 90% confidence intervals separately for each study cohort. Comparisons to Center for International Blood and Marrow Transplant Research (CIBMTR) patients will use log-rank tests.
7 secondary outcomes
Progression-Free survival (PFS)
Time frame: At 1 and 2 years
Overall Survival (OS)
Time frame: At 1 and 2 years
Cumulative incidence of grade II-IV acute GVHD (allo-SCT cohort)
Time frame: Up to 5 years
Cumulative incidence of chronic extensive GvHD (allo-SCT cohort)
Time frame: at 1 year post-SCT
Cumulative Incidence of non-relapse mortality (NRM) at 1-year after (auto-SCT, allo-SCT, whole cohort)
Time frame: At 1 year
Rates of grade 3-4 treatment Emergent Adverse Events
Time frame: Up to 2 years
Rate of patients completing 1-year post-SCT maintenance Ruxolitinib
Time frame: At 1 year post-SCT
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 27 Oct 2026.
- The JameslineLink provided by the sponsor.
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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.
The Ohio State University Comprehensive Cancer Center contact
Jonathan Brammer, MD principal investigator
Ohio State University Comprehensive Cancer Center
2 sites 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, Positron emission tomography-computed tomography and Bone Marrow Biopsy in people with T-cell Lymphoma and Graft Versus Host Disease, run by Ohio State University Comprehensive Cancer Center at 2 sites 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 8 inclusion and 15 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 The Ohio State University Comprehensive Cancer Center (1-800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence (CI) of relapse (time frame: at 1-year post-auto-SCT). The study lists 2 primary outcomes in all. 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 27 Oct 2026.