Relapsed B-Cell Acute Lymphoblastic LeukemiaPhase 1NCT01860937
T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adult Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia
A Phase 1 study testing leukapheresis or collection of PBMCs, cyclophosphamide based chemotherapy regimens and modified T cells in people with Relapsed B-Cell Acute Lymphoblastic Leukemia, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to test the safety of giving the patient special cells made from their own blood called "Modified T-cells". The goal is to find a safe dose of modified T-cells for patients whose leukemia has returned to the bone marrow. Read more about this study
- Who is it for?
- Ages Up to 26 years
- Conditions the study is for
- Relapsed B-Cell Acute Lymphoblastic Leukemia
- What is being tested?
- leukapheresis or collection of PBMCs, cyclophosphamide based chemotherapy regimens and modified T cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to May 2027
- Phase
- Phase 1
- 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 Up to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age < 26 years, whose disease meets one of the following 3 criteria:
- VHR*
- Patients in 1st or subsequent marrow relapse (isolated or combined), at the time of relapse, during retrieval therapy, or after achievement of CR.
- Refractory disease *Definitions of VHR B-ALL include the following:
- NCI HR-ALL and age ≥ 13 years at diagnosis
- CNS-3 leukemia at diagnosis
Show all 30Show fewer
- Day 29/End of Induction BM MRD > 0.01%
- Induction failure (M3 BM at Day 29/End of Induction)
- Hypodiploidy (n< 44 chromosomes and/or a DNA index < 0.81)
- t(9;22) ALL (Philadelphia Chromosome/Ph+ ALL)
- t(17;19) ALL or Ph-Like ALL
- MLL gene rearrangement
- IKZF1 deletions
- Intrachromosomal amplification of chromosome 21 (iAMP21) Please note patients that only meet the criteria for collection/storage of PBMCs will need to be reconsented prior to infusion of genetically modified T-cells.
- Patients must have a history of relapsed/refractory CD19+ B-ALL involving the marrow to be eligible for infusion of modified T cells.
- Please note ≥5% blasts by morphology, FISH/cytogenetics, molecular translocation and/or flow cytometry constitutes a bone marrow relapse on this protocol. Patients must also fulfill one of the following criteria to be eligible for infusion of modified T cells:
- Second or greater (≥2) relapse
- Early first marrow relapse (1st CR <18 months)
- Intermediate/Late first marrow relapse (1st CR >18 months) with poor initial response (≥5% blasts by morphology and/or flow cytometry) following reinduction chemotherapy
- Refractory Disease
- Ineligible for HSCT as determined by the treating physician in consultation with the BMT service
- Patient would not benefit from additional chemotherapy as determined by the treating physician
- KPS or Lansky score ≥ 60
- Pulmonary function (measured prior to conditioning chemotherapy):
- o > 90% oxygen saturation on room air by pulse oximetry.
- Renal Function (measured prior to conditioning chemotherapy):
- o Serum creatinine ≤2.0mg/dL for patients over 18 years or ≤2.5 x institutional ULN for age
- Hepatic Function (measured prior to conditioning chemotherapy):
- AST ≤ 5 x the institutional ULN. Elevation secondary to leukemic involvement is not an exclusion criterion. Leukemic involvement will be determined by the presence of progressive relapse defined by escalating bone marrow or peripheral blood leukemia blasts within the previous month and the absence of initiation of know hepatotoxic medication (e.g. azoles).
- Total bilirubin ≤ 2.5 x the institutional ULN
Who cannot join
- Karnofsky/Lansky performance status <60.
- Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
- Patients with active HIV, hepatitis B or hepatitis C infection.
- Females who are pregnant
- Karnofsky/Lansky performance status <60.
- Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
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- Patients will be excluded if they have isolated extra-medullary relapse of ALL
- Females who are pregnant.
- Patients with active (grade 2-4) acute graft versus host disease (GVHD), chronic GVHD or an overt autoimmune disease (e.g. hemolytic anemia) following allo-HSCT requiring glucocorticosteroid treatment (>0.5 mg/kg/day prednisone or its equivalent) as treatment.
- Active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) within 7 days of treatment or symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurologic dysfunction) within 28 days of treatment. Prophylactic intrathecal medication is not a reason for exclusion.
- o If the LP is traumatic (containing RBCs) and cannot be repeated the Steinherz/Bleyer ratio will be used to determined unequivocal evidence of CSF leukemia at the discretion of the treating physician.
- Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the treating investigator would pose an unacceptable risk to the subject.
- Prior neurologic toxicity to previous immunotherapy
- Preceding and/or ongoing organ dysfunction or other co-morbidity including but not limited to uncontrolled infection that would impair the patient's ability to endure known side effects of cytokine release syndrome or neurologic toxicity
- Recent prior therapy: Systemic chemotherapy less than 2 weeks prior to infusion or apheresis (6 weeks for clofarabine or nitrosoureas for apheresis) or radiation therapy less than or equal to 3 weeks prior to apheresis. Exceptions:
- oThere is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such.
- oSubjects receiving hydroxyurea or oral maintenance chemotherapy may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis or treatment.
- oSubjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis or treatment.
- oSubjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met. Cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion.
- •Rapidly progressive disease that in the estimation of the treating physician would compromise ability to complete study therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute:Dana- Farber/Children's Hospital
Boston, Massachusetts, 02115
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase I Trial of T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adult Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia
The purpose of this study is to test the safety of giving the patient special cells made from their own blood called "Modified T-cells". The goal is to find a safe dose of modified T-cells for patients whose leukemia has returned to the bone marrow.
Read the detailed description
This is a phase I multicenter clinical trial for pediatric and young adult patients with relapsed/refractory CD19+ B-ALL. The T cell doses originally proposed in this study were based on doses administered safely in prior T cell adoptive therapy trials, but the dose has been modified based on the toxicities observed in adult patients with morphologic evidence of relapsed B-ALL treated on MSKCC IRB 09-114.
- Being tested
- leukapheresis or collection of PBMCs, cyclophosphamide based chemotherapy regimens, modified T cells
- Keywords
- T cell Immunotherapy, CD19 Targeted Therapy, Chimeric Antigen Receptor (CAR) Modified T cells, Conditioning Chemotherapy, 13-052
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leukapheresis or collection of PBMCsProcedure or surgery
cyclophosphamide based chemotherapy regimensDrug
modified T cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (MRD) | Experimental | Patients with no morphologic evidence of disease at the time of T cell infusion, (<5% blasts in the bone marrow) as assessed by morphology or flow cytometry. Participating site PI to determine cohort stratification in the event of morphology/flow cytometry blast count discrepancy. Cohort 1 patients will receive conditioning chemotherapy followed by 1x10^6 19-28z+ T cells/kg over 1 to 2 days. During formulation of End of Production (EOP) T cells, under or over estimation of CAR modified T-cells may occur. Patients may receive an altered fractionation of the total doses (e.g. ½ on Day 0 and ½ on Day +1) or up to 35% over total cell dose with approval by the participating site PI. In both cohorts, patients will be allowed to receive a 2nd treatment of 19-28z+ T cells if they benefited from the first infusion and did not experience any non-hematologic grade 4 toxicities. Receives: Procedure: leukapheresis or collection of PBMCs; Drug: cyclophosphamide based chemotherapy regimens; Biological: modified T cells |
| Cohort 2 (Morphologic Disease) | Experimental | Pts with morphologic evidence of disease at the time of T cell infusion, (≥5% blasts in the bone marrow) as assessed by morphology or flow cytometry. Participating site PI to determine cohort stratification in the event of morphology/flow cytometry blast count discrepancy. Pts with increased blasts (5-10% blasts) that are immunophenotypically consistent with recovering marrow from prior re-induction chemo may be treated under Cohort 1 with approval of the participating site PI. Cohort 2 pts will get conditioning chemo followed by 1x10^6 19-28z+ T cells/kg over 1 to 2 days. During formulation of EOP T cells, under or over estimation of CAR modified T-cells may occur. Pts may get up to 35% over total cell dose with approval by the participating site PI. Both cohorts, pts will be allowed to receive a 2nd treatment of 19-28z+ T cells if they benefited from the first infusion \& did not experience any non-hematologic grade 4 toxicities. Receives: Procedure: leukapheresis or collection of PBMCs; Drug: cyclophosphamide based chemotherapy regimens; Biological: modified T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
of gene-modified autologous T cells targeted to CD19 and infused into patients with relapsed/refractory B- ALL. Toxicities will be graded on a scale of 1 to 5 as described by the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Adverse Events/Toxicities will be graded/attributed starting at time of T cell infusion and continue for up to 30 days or until modified T cells are no longer present.
Measured: 1 year
Secondary outcomes (2)
assess the persistence of modified T cells
Gene-modified T cells will be measured as per Table II from peripheral blood, bone marrow and/or lymph nodes. The percentage of gene-modified T cells T cells will be calculated and summarized at each follow-up time point. The data will be plotted over time to describe the time trend of T cell persistence.
Measured: 1 year
the development of B cell aplasia
B cell aplasia will be measured as a surrogate marker for 19-28z+ T cell efficacy. Serum levels of normal B cells from peripheral blood and bone marrow aspirates will be monitored by FACS. The mean cell concentrations will be summarized and plotted against time.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsed B-Cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Kevin Curran, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860937
- Sponsor's protocol ID
- 13-052
- Status last verified
- Jun 2026
- First submitted
- 21 May 2013
- Last updated
- 8 Jun 2026
- Results posted
- No
Publications
Valtis YK, Lin C, Nemirovsky D, Devlin S, Rejeski K, Curran KJ, Wang X, Shah NN, Jeyakumar N, Miller K, Zhang A, Kota VK, Al Darobi AH, Muhsen I, Sasine J, Aldoss I, Advani AS, Reshef R, Chen EC, Kopmar N, Tsai SB, Hilal T, Shah BD, Faramand R, Solh MM, Tan V, Bezerra E, Battiwalla M, Ramakrishnan A, Mathews J, Shaughnessy P, Mountjoy L, Hoeg RT, Dykes KC, Logan AC, Kumaran MV, Schwartz M, Tracy S, Moore J, Odstrcil Bobillo S, Frey NV, Connor M, Ladha A, Dholaria B, Sutherland K, Roloff GW, Muffly LS, Park JH. CAR HEMATOTOX independently predicts outcomes after CD19 CAR-T therapy for acute lymphoblastic leukemia. Blood Adv. 2026 Jan 13;10(1):276-288. doi: 10.1182/bloodadvances.2025017526.
PubMed 41052404Curran KJ, Margossian SP, Kernan NA, Silverman LB, Williams DA, Shukla N, Kobos R, Forlenza CJ, Steinherz P, Prockop S, Boulad F, Spitzer B, Cancio MI, Boelens JJ, Kung AL, Khakoo Y, Szenes V, Park JH, Sauter CS, Heller G, Wang X, Senechal B, O'Reilly RJ, Riviere I, Sadelain M, Brentjens RJ. Toxicity and response after CD19-specific CAR T-cell therapy in pediatric/young adult relapsed/refractory B-ALL. Blood. 2019 Dec 26;134(26):2361-2368. doi: 10.1182/blood.2019001641.
PubMed 31650176
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adult Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT01860937
- Acronym / sponsor ID
- 13-052
- Keywords
- T cell Immunotherapy, CD19 Targeted Therapy, Chimeric Antigen Receptor (CAR) Modified T cells, Conditioning Chemotherapy, 13-052
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- May 2013 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 May 2013 (estimated)
- 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 purpose of this study is to test the safety of giving the patient special cells made from their own blood called "Modified T-cells". The goal is to find a safe dose of modified T-cells for patients whose leukemia has returned to the bone marrow.
Detailed description
This is a phase I multicenter clinical trial for pediatric and young adult patients with relapsed/refractory CD19+ B-ALL. The T cell doses originally proposed in this study were based on doses administered safely in prior T cell adoptive therapy trials, but the dose has been modified based on the toxicities observed in adult patients with morphologic evidence of relapsed B-ALL treated on MSKCC IRB 09-114.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (MRD) | Experimental | Procedure: leukapheresis or collection of PBMCs, Drug: cyclophosphamide based chemotherapy regimens, Biological: modified T cellsPatients with no morphologic evidence of disease at the time of T cell infusion, (<5% blasts in the bone marrow) as assessed by morphology or flow cytometry. Participating site PI to determine cohort stratification in the event of morphology/flow cytometry blast count discrepancy. Cohort 1 patients will receive conditioning chemotherapy followed by 1x10^6 19-28z+ T cells/kg over 1 to 2 days. During formulation of End of Production (EOP) T cells, under or over estimation of CAR modified T-cells may occur. Patients may receive an altered fractionation of the total doses (e.g. ½ on Day 0 and ½ on Day +1) or up to 35% over total cell dose with approval by the participating site PI. In both cohorts, patients will be allowed to receive a 2nd treatment of 19-28z+ T cells if they benefited from the first infusion and did not experience any non-hematologic grade 4 toxicities. |
| Cohort 2 (Morphologic Disease) | Experimental | Procedure: leukapheresis or collection of PBMCs, Drug: cyclophosphamide based chemotherapy regimens, Biological: modified T cellsPts with morphologic evidence of disease at the time of T cell infusion, (≥5% blasts in the bone marrow) as assessed by morphology or flow cytometry. Participating site PI to determine cohort stratification in the event of morphology/flow cytometry blast count discrepancy. Pts with increased blasts (5-10% blasts) that are immunophenotypically consistent with recovering marrow from prior re-induction chemo may be treated under Cohort 1 with approval of the participating site PI. Cohort 2 pts will get conditioning chemo followed by 1x10^6 19-28z+ T cells/kg over 1 to 2 days. During formulation of EOP T cells, under or over estimation of CAR modified T-cells may occur. Pts may get up to 35% over total cell dose with approval by the participating site PI. Both cohorts, pts will be allowed to receive a 2nd treatment of 19-28z+ T cells if they benefited from the first infusion \& did not experience any non-hematologic grade 4 toxicities. |
Who may qualify
- Ages
- Up to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (30 listed)
- VHR*
- Patients in 1st or subsequent marrow relapse (isolated or combined), at the time of relapse, during retrieval therapy, or after achievement of CR.
- Refractory disease *Definitions of VHR B-ALL include the following:
- Patients must have a history of relapsed/refractory CD19+ B-ALL involving the marrow to be eligible for infusion of modified T cells.
- Please note ≥5% blasts by morphology, FISH/cytogenetics, molecular translocation and/or flow cytometry constitutes a bone marrow relapse on this protocol. Patients must also fulfill one of the following criteria to be eligible for infusion of modified T cells:
Key exclusion criteria (20 listed)
- Karnofsky/Lansky performance status <60.
- Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
- Patients with active HIV, hepatitis B or hepatitis C infection.
- Females who are pregnant
- Karnofsky/Lansky performance status <60.
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 |
|---|---|---|
| leukapheresis or collection of PBMCs | Procedure or surgery | Cohort 1 (MRD), Cohort 2 (Morphologic Disease) |
| cyclophosphamide based chemotherapy regimens | Drug | Cohort 1 (MRD), Cohort 2 (Morphologic Disease) |
| modified T cells | Biological | Cohort 1 (MRD), Cohort 2 (Morphologic Disease) |
Primary outcome
safety
Time frame: 1 year
of gene-modified autologous T cells targeted to CD19 and infused into patients with relapsed/refractory B- ALL. Toxicities will be graded on a scale of 1 to 5 as described by the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Adverse Events/Toxicities will be graded/attributed starting at time of T cell infusion and continue for up to 30 days or until modified T cells are no longer present.
2 secondary outcomes
assess the persistence of modified T cells
Time frame: 1 year
the development of B cell aplasia
Time frame: 1 year
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 8 Jun 2026.
- Derived from this study: PubMed 41052404Valtis YK, Lin C, Nemirovsky D, Devlin S, Rejeski K, Curran KJ, Wang X, Shah NN, Jeyakumar N, Miller K, Zhang A, Kota VK, Al Darobi AH, Muhsen I, Sasine J, Aldoss I, Advani AS, Reshef R, Chen EC, Kopmar N, Tsai SB, Hilal T, Shah BD, Faramand R, Solh MM, Tan V, Bezerra E, Battiwalla M, Ramakrishnan A, Mathews J, Shaughnessy P, Mountjoy L, Hoeg RT, Dykes KC, Logan AC, Kumaran MV, Schwartz M, Tracy S, Moore J, Odstrcil Bobillo S, Frey NV, Connor M, Ladha A, Dholaria B, Sutherland K, Roloff GW, Muffly LS, Park JH. CAR HEMATOTOX independently predicts outcomes after CD19 CAR-T therapy for acute lymphoblastic leukemia. Blood Adv. 2026 Jan 13;10(1):276-288. doi: 10.1182/bloodadvances.2025017526.
- Derived from this study: PubMed 31650176Curran KJ, Margossian SP, Kernan NA, Silverman LB, Williams DA, Shukla N, Kobos R, Forlenza CJ, Steinherz P, Prockop S, Boulad F, Spitzer B, Cancio MI, Boelens JJ, Kung AL, Khakoo Y, Szenes V, Park JH, Sauter CS, Heller G, Wang X, Senechal B, O'Reilly RJ, Riviere I, Sadelain M, Brentjens RJ. Toxicity and response after CD19-specific CAR T-cell therapy in pediatric/young adult relapsed/refractory B-ALL. Blood. 2019 Dec 26;134(26):2361-2368. doi: 10.1182/blood.2019001641.
- Memorial Sloan Kettering Cancer CenterLink 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. This study is not recruiting at the moment.
Kevin Curran, MD principal investigator
Memorial Sloan Kettering 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 1 study testing leukapheresis or collection of PBMCs, cyclophosphamide based chemotherapy regimens and modified T cells in people with Relapsed B-Cell Acute Lymphoblastic Leukemia, run by Memorial Sloan Kettering 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 30 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 8 Jun 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
safety (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01860937, which also lists 2 linked publications.
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 8 Jun 2026.