Drug ToxicityNCT07008027
Real World Asparaginase Therapy Toxicity
An observational study of Drug Toxicity, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This research study is being done to learn more about the short term and long term side effects of treatment with asparaginase drugs, which are commonly used in acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma (LLy) therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Toxicity
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jul 2031
- Phase
- Observational
- 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
Study population: Participants meeting the Eligibility Criteria.
Who may be able to join
- Diagnosis of acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia
- Enrolled on INITIALL and no more than 10 days after initiation of post-INITIALL therapy
- Post-INITIALL therapy is:
- Standard of Care (SOC)/Non Protocol Treatment Plan (NPTP) as per Total therapy or
- SJALL23T and not scheduled to receive venetoclax
Who cannot join
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
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
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Seth E. Karol, 888-226-4343, referralinfo@stjude.org
Seth E. Karol, MD, MSCI
About this study
This research study is being done to learn more about the short term and long term side effects of treatment with asparaginase drugs, which are commonly used in acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma (LLy) therapy.
Read the detailed description
Primary Objective
- To estimate the rate of high-grade toxicities which occur during therapy for acute lymphoblastic leukemia/ lymphoma in patients receiving asparaginase-containing standard of care therapy.
This study will involve the collection of data about the participants ALL/LLy, treatment, side effects of treatment and leukemia/ lymphoma's response to treatment. Data collected on other research studies participants are enrolled on will also be used for this research study.
Blood samples will be collected and liver fibroscans (liver ultrasounds) will be done at different time points while the participant is receiving treatment for ALL/LLy. The time points will depend on what treatment they receive and will correspond to days on their treatment roadmap.
- Conditions
- Drug Toxicity
- Keywords
- Asparaginase drugs, Toxicity, Acute lymphoblastic leukemia, Acute lymphoblastic lymphoma, Mixed phenotype acute leukemia
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-protocol therapy /standard of care therapy | Participants receiving non -protocol standard if care (SOC) treatment. | |
| SJALL23T (NCT06390319) protocol therapy | Participants receiving protocol therapy on SJALL23T and not receiving investigational drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy
The overall probability of on-therapy grade 3+ or 4+ toxicity will be estimated by the sample proportion along with the Normal approximation (Z-statistic) based 95% confidence interval.
Measured: Approximately 2½ to 3 years
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy
The overall probability of on-therapy grade 3+ or 4+ toxicity will be estimated by the sample proportion along with the Normal approximation (Z-statistic) based 95% confidence interval.
Measured: Approximately 2½ to 3 years
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SOC therapy
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
Measured: Approximately 2½ to 3 years
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SJALL23T therapy
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
Measured: Approximately 2½ to 3 years
Probabilities of grade 3+ or 4+ toxicities each phase of SOC treatment
Probabilities of grade 3+ or 4+ toxicities will be estimated for each treatment phase by sample proportions accompanied by the Z-statistic 95% confidence intervals.
Measured: Approximately 2½ to 3 years
Probabilities of grade 3+ or 4+ toxicities each phase of SJALL23Ttreatment
Probabilities of grade 3+ or 4+ toxicities will be estimated for each treatment phase by sample proportions accompanied by the Z-statistic 95% confidence intervals.
Measured: Approximately 2½ to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study startNov 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ToxicityStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth E. Karol, MD, MSCI, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008027
- Sponsor's protocol ID
- REWASPY
- Status last verified
- Oct 2026
- First submitted
- 28 May 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Asparaginase Therapy Toxicity
- ClinicalTrials.gov ID
- NCT07008027
- Acronym / sponsor ID
- REWASPY
- Conditions
- Drug Toxicity
- Keywords
- Asparaginase drugs, Toxicity, Acute lymphoblastic leukemia, Acute lymphoblastic lymphoma, Mixed phenotype acute leukemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 6 Jun 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 research study is being done to learn more about the short term and long term side effects of treatment with asparaginase drugs, which are commonly used in acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma (LLy) therapy.
Detailed description
Primary Objective
- To estimate the rate of high-grade toxicities which occur during therapy for acute lymphoblastic leukemia/ lymphoma in patients receiving asparaginase-containing standard of care therapy.
This study will involve the collection of data about the participants ALL/LLy, treatment, side effects of treatment and leukemia/ lymphoma's response to treatment. Data collected on other research studies participants are enrolled on will also be used for this research study.
Blood samples will be collected and liver fibroscans (liver ultrasounds) will be done at different time points while the participant is receiving treatment for ALL/LLy. The time points will depend on what treatment they receive and will correspond to days on their treatment roadmap.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-protocol therapy /standard of care therapy | – | –Participants receiving non -protocol standard if care (SOC) treatment. |
| SJALL23T (NCT06390319) protocol therapy | – | –Participants receiving protocol therapy on SJALL23T and not receiving investigational drug. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants meeting the Eligibility Criteria.
Key inclusion criteria (5 listed)
- Diagnosis of acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia
- Enrolled on INITIALL and no more than 10 days after initiation of post-INITIALL therapy
- Post-INITIALL therapy is:
Key exclusion criteria (1 listed)
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy
Time frame: Approximately 2½ to 3 years
The overall probability of on-therapy grade 3+ or 4+ toxicity will be estimated by the sample proportion along with the Normal approximation (Z-statistic) based 95% confidence interval.
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy
Time frame: Approximately 2½ to 3 years
The overall probability of on-therapy grade 3+ or 4+ toxicity will be estimated by the sample proportion along with the Normal approximation (Z-statistic) based 95% confidence interval.
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SOC therapy
Time frame: Approximately 2½ to 3 years
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SJALL23T therapy
Time frame: Approximately 2½ to 3 years
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
Probabilities of grade 3+ or 4+ toxicities each phase of SOC treatment
Time frame: Approximately 2½ to 3 years
Probabilities of grade 3+ or 4+ toxicities will be estimated for each treatment phase by sample proportions accompanied by the Z-statistic 95% confidence intervals.
Probabilities of grade 3+ or 4+ toxicities each phase of SJALL23Ttreatment
Time frame: Approximately 2½ to 3 years
Probabilities of grade 3+ or 4+ toxicities will be estimated for each treatment phase by sample proportions accompanied by the Z-statistic 95% confidence intervals.
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 22 Oct 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink 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.
Seth E. Karol, MD, MSCI principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Toxicity, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 22 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 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 Seth E. Karol, MD, MSCI (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy (time frame: Approximately 2½ to 3 years). The study lists 6 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 22 Oct 2026.