B-cell Acute Lymphoblastic LeukemiaPhase 3NCT07223021
A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
A Phase 3 study testing Fludarabine, Cyclophosphamide and CAR-T in people with B-cell Acute Lymphoblastic Leukemia, run by Memorial Sloan Kettering Cancer Center at 6 sites in 2 countries.
Trial summary
The researchers are doing this study to find out whether PK-targeted fludarabine is an effective Lymphodepletion (LD) chemotherapy approach for people with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who will receive tisagenlecleucel CAR T-cell therapy. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- Fludarabine, Cyclophosphamide and CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 20 Oct 2025to Oct 2028
- Phase
- Phase 3
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with B-ALL and eligible to receive commercial tisagenlecleucel.
- Patient's weight > 9 kg at time of lymphodepleting chemotherapy
- Adequate organ function at time of LD is required and is defined:
- Hepatic: Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia
- Hepatic: AST and ALT < 5x the upper limit of normal for age, unless thought to be leukemic disease-related
- Renal: Calculated glomerular filtration rate (GFR) ≥ 70 ml/min/1.73m^2. (based on Schwartz formula GFR (mL/min/1.73 m²) = (36.2 × Height in cm) / Creatinine in mg/dL
Show all 12Show fewer
- Cardiac: LVEF ≥ 50% by multi-gated acquisition scan (MUGA), resting echocardiogram, or cardiac magnetic resonance imaging (MRI) within 6 weeks of screening
- Pulmonary: Oxygen saturation as recorded by pulse oximetry of ≥ 90% on room air
- Adequate performance status:
- Age ≥ 16 years: ECOG ≤ 1 or Karnofsky > 60% at treatment
- Age < 16 years: Lansky ≥ 60% at treatment
- Willing to participate as research subject and provide written informed consent from parents/legal representative, patient, and age-appropriate assent as appropriate before any study specific screening procedures are conducted, according to local, regional or national law and legislation.
Who cannot join
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including fludarabine, cyclophosphamide and tisagenlecleucel.
- Patients with tisagenlecleucel that is deemed out of specification (OOS) will be excluded from this protocol
- Clinically significant active and uncontrolled infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA etc.)
- Patient/parent/guardian unable to give informed consent or unable to comply with the treatment protocol.
- Pregnant or lactating women
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Jaap Jan Boelens, MD, PhD contact
6 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center (Data Collection Only)
Cincinnati, Ohio, 45229
Christine Phillips, MD, 513-636-4266
- Not yet recruiting
Baylor College Medical Center (Data Collection Only)
Houston, Texas, 77030
Rayne Rouce, MD, rouce@bcm.edu
- Recruiting
Texas Children's Hospital (Data Collection)
Houston, Texas, 77030
Rayne Rouce, M.D., B.S., 832-822-4242
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Kevin Curran, MD, 1-833-MSK-KIDS
Jaap Jan Boelens, MD,PhD, 1-833-MSK-KIDS
- Recruiting
Children's Hospital of Philadelphia (Data Collection Only)
Philadelphia, Pennsylvania, 19104
Regina Myers, MD, 267-426-0762
Netherlands1 site, 1 recruiting
- Recruiting
Prinses Máxima Centrum (Data Collection and Analysis)
Utrecht
Friso Calkoen, MD, +31 88 972 7272
About this study
Official title: Improving EveNt Free Survival by Optimizing FLUdarabine Exposure During LymphodepletioN for CAR T CEll Therapy: a Randomized, Multi-center Study of Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (INFLUENCE)
The researchers are doing this study to find out whether PK-targeted fludarabine is an effective Lymphodepletion (LD) chemotherapy approach for people with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who will receive tisagenlecleucel CAR T-cell therapy. The researchers will compare PK-targeted fludarabine dosing with standard fludarabine dosing to see which treatment approach is more effective. The researchers will also look at whether PK-targeted fludarabine dosing is feasible (practical), the side effects of the study treatment, and how the study treatment affects people's quality of life. The researchers will measure quality of life by having participants complete questionnaires.
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- Fludarabine, Cyclophosphamide, CAR-T
- Keywords
- Fludarabine
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Fludarabine 30 mg/m2/dose x 4 doses on days -6 to -3 (or -7 to -4)
CyclophosphamideDrug
All patients will receive Cyclophosphamide 500 mg/m2 IV on days -6 and -5 (or -7 and -6).
FludarabineDrug
Targeted fludarabine LD: Fludarabine 40 mg/m2/dose x 2 doses on days -6 and -5 (or
-7 and -6), with doses on days -4 and -3 (or -5 and -4, if starting lymphodepletion on day -7) adjusted based on PK analysis to target a cumulative area under the curve (AUC) of 18 mg*h/L (range 17.5-18.5mg*h/L)
CAR-TBiological
will be infused based on institutional guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Standard Fludarabine regimen followed by CAR-T | Active comparator | Fludarabine 30 mg/m2/dose x 4 doses on days -6 to -3 (or -7 to -4) Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: CAR-T |
| Targeted fludarabine regimen followed by CAR-T | Experimental | Fludarabine 40 mg/m2/dose x 2 doses on days -6 and -5 (or -7 and -6), with doses on days -4 and -3 (or -5 and -4, if starting lymphodepletion on day -7) adjusted based on PK analysis to target a cumulative area under the curve (AUC) of 18 mg*h/L (range 17.5-18.5mg*h/L Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the event free survival (EFS )
EFS is defined as time from randomization until non-response at day 28 after CAR T cell infusion, loss of B-cell aplasia <6 months from the time of CAR T cell infusion, disease relapse, initiation of anti-leukemic therapy or death of any cause
Measured: 28 days
Secondary outcomes (1)
survival
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 Oct 2025
- Study start20 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized open-label multicenter trial.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Maxima Center for Pediatric Oncology
- Responsible party
- Sponsor
- Investigators
- Kevin Curran, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223021
- Sponsor's protocol ID
- 25-072
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving EveNt Free Survival by Optimizing FLUdarabine Exposure During LymphodepletioN for CAR T CEll Therapy: a Randomized, Multi-center Study of Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (INFLUENCE)
- ClinicalTrials.gov ID
- NCT07223021
- Acronym / sponsor ID
- 25-072
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Keywords
- Fludarabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Princess Maxima Center for Pediatric Oncology
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 31 Oct 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.
The researchers are doing this study to find out whether PK-targeted fludarabine is an effective Lymphodepletion (LD) chemotherapy approach for people with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who will receive tisagenlecleucel CAR T-cell therapy. The researchers will compare PK-targeted fludarabine dosing with standard fludarabine dosing to see which treatment approach is more effective. The researchers will also look at whether PK-targeted fludarabine dosing is feasible (practical), the side effects of the study treatment, and how the study treatment affects people's quality of life. The researchers will measure quality of life by having participants complete questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a randomized open-label multicenter trial.
| Arm | Type | Receives |
|---|---|---|
| Standard Fludarabine regimen followed by CAR-T | Active comparator | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: CAR-TFludarabine 30 mg/m2/dose x 4 doses on days -6 to -3 (or -7 to -4) |
| Targeted fludarabine regimen followed by CAR-T | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: CAR-TFludarabine 40 mg/m2/dose x 2 doses on days -6 and -5 (or -7 and -6), with doses on days -4 and -3 (or -5 and -4, if starting lymphodepletion on day -7) adjusted based on PK analysis to target a cumulative area under the curve (AUC) of 18 mg*h/L (range 17.5-18.5mg*h/L |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with B-ALL and eligible to receive commercial tisagenlecleucel.
- Patient's weight > 9 kg at time of lymphodepleting chemotherapy
- Adequate organ function at time of LD is required and is defined:
- Adequate performance status:
- Willing to participate as research subject and provide written informed consent from parents/legal representative, patient, and age-appropriate assent as appropriate before any study specific screening procedures are conducted, according to local, regional or national law and legislation.
Key exclusion criteria (5 listed)
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including fludarabine, cyclophosphamide and tisagenlecleucel.
- Patients with tisagenlecleucel that is deemed out of specification (OOS) will be excluded from this protocol
- Clinically significant active and uncontrolled infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA etc.)
- Patient/parent/guardian unable to give informed consent or unable to comply with the treatment protocol.
- Pregnant or lactating women
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 |
|---|---|---|
| FludarabineFludarabine 30 mg/m2/dose x 4 doses on days -6 to -3 (or -7 to -4) | Drug | Standard Fludarabine regimen followed by CAR-T |
| CyclophosphamideAll patients will receive Cyclophosphamide 500 mg/m2 IV on days -6 and -5 (or -7 and -6). | Drug | Standard Fludarabine regimen followed by CAR-T, Targeted fludarabine regimen followed by CAR-T |
| FludarabineTargeted fludarabine LD: Fludarabine 40 mg/m2/dose x 2 doses on days -6 and -5 (or -7 and -6), with doses on days -4 and -3 (or -5 and -4, if starting lymphodepletion on day -7) adjusted based on PK analysis to target a cumulative area under the curve (AUC) of 18 mg*h/L (range 17.5-18.5mg*h/L) | Drug | Targeted fludarabine regimen followed by CAR-T |
| CAR-Twill be infused based on institutional guidelines. | Biological | Standard Fludarabine regimen followed by CAR-T, Targeted fludarabine regimen followed by CAR-T |
Primary outcome
compare the event free survival (EFS )
Time frame: 28 days
EFS is defined as time from randomization until non-response at day 28 after CAR T cell infusion, loss of B-cell aplasia <6 months from the time of CAR T cell infusion, disease relapse, initiation of anti-leukemic therapy or death of any cause
1 secondary outcome
survival
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 5 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Related trials for B-cell Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
RecruitingPhase 2
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, B-All
RecruitingPhase 3
International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)
B-Cell Acute Lymphoblastic Leukaemia
Active, not recruitingPhase 3
Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
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.
Jaap Jan Boelens, MD, PhD contact
Kevin Curran, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fludarabine, Cyclophosphamide and CAR-T in people with B-cell Acute Lymphoblastic Leukemia, run by Memorial Sloan Kettering Cancer Center at 6 sites in 2 countries.
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 12 inclusion and 5 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 5 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 6 sites in United States, Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Kevin Curran, MD (1-833-MSK-KIDS, currank@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the event free survival (EFS ) (time frame: 28 days). 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 5 Oct 2026.