Acute Lymphoblastic LeukemiaPhase 1NCT05581030
CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
A Phase 1 study testing Calaspargase Pegol and Rituximab in people with Acute Lymphoblastic Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Calaspargase Pegol and Rituximab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to Oct 2026
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pathologically confirmed Philadelphia negative B- or T-cell acute lymphoblastic leukemia, with >10% peripheral blood or bone marrow lymphoblasts at diagnosis.
- Treatment and full recovery from arm 1A of the Hyper-CVAD regimen.
- Be willing and able to provide written informed consent/assent for the trial.
- Able to adhere to the study visit schedule and other protocol requirements.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Cardiac ejection fraction ≥ 50% by echocardiography or MUGA, as measured prior to arm 1A of Hyper-CVAD.
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- Serum bilirubin and creatinine < 1.5x upper limit of normal (ULN). AST and ALT must be <3x ULN.
- Females of childbearing potential (FCBP) must have a negative serum pregnancy test at screening. A FCBP is considered when a sexually mature female: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months.
- A FCBP must agree to use of two methods of highly effective non-hormonal contraception, be surgically sterile, or abstain from heterosexual activity for the course of the study through 3 monthsafter the last dose of study treatment.
- Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 30 days after the last dose of study therapy. Men must agree to not donate sperm during and after the study for 3 months
Who cannot join
- Induction therapy with any regimen other than Hyper-CVAD 1A.
- Diagnosis of L3 type Burkitt's lymphoma
- Clinical evidence of active central nervous system (CNS) leukemia.
- Any major surgery or radiation therapy within four weeks.
- Diagnosis of Down Syndrome.
- Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or Hepatitis C.
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- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to unstable angina, pre-existing liver disease, recurrent pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension, or severeheart failure (New York Heart Association Class III-IV).
- Recurrent thrombosis, or non-central venous catheter associated thrombosis within 3 months prior to enrollment.
- Severe comorbid conditions for which life expectancy would be <6 months.
- Patients with active (uncontrolled, metastatic) second malignancies are excluded.
- Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.
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
Moffitt Cancer Center
Tampa, Florida, 33612
Hannah Lewis, 813-745-8650, Hannah.Lewis@moffitt.org
Bijal Shah, MD
About this study
Official title: A Single-Arm, Open-Label Phase 1b Study of Hyper-CVAD + Calaspargase Pegol in Young Adults With Newly Diagnosed Acute Lymphoblastic Leukemia
The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy), Calaspargase Pegol, Rituximab
- Keywords
- A.L.L.
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy)Drug
Hyper-CVAD consists of two combinations of drugs (courses A and B) given in an alternating fashion. The term "hyper" refers to the hyperfractionated nature of the chemotherapy, which is given in small doses, more frequently, to minimize side effects. CVAD is the acronym of the drugs in course a: cyclophosphamide, vincristine, doxorubicin and dexamethasone.
Course A: Cyclophosphamide days 1, 2 and 3. Vincristine days 4 and 11, Doxorubicin day 4, dexamethasone days 1-4 and 11-14, Cytarabine day 7. Mesna is also given orally with cyclophosphamide, to reduce the incidence of haemorrhagic cystitis, a common side effect of cyclophosphamide. Methotrexate, an antimetabolite, may be given when necessary to get chemotherapy past the blood brain barrier.
Course B: Methotrexate Day 1 and Cytarabine Days 2 and 3. Dosage is individualized to the patient.
Calaspargase PegolDrug
Also called Asparlas, CalPeg
Calaspargase pegol 2000 IU/m^2 (capped at 3750 IU) will be administered beginning in cycle 1B of Hyper-CVAD, and will continue at this dose for the duration of the trial.
RituximabDrug
Also called Rituxan
Rituximab 375mg/m^2 will be administered once per cycle for patients with CD20+ ALL.
| Study group | Role | What they receive |
|---|---|---|
| Hyper-CVAD + Calaspargase pegol Treatment | Experimental | Participants will receive calaspargase pegol administered over 1 hour with each cycle of Hyper-CVAD, mini-CVD, and late intensification, beginning with Cycle 1B. Responding patients will have dose reduction of HyperCVAD for Cycles 2B-4B. Participants with CD20+ ALL will also be given Rituximab once per cycle. Receives: Drug: Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy); Drug: Calaspargase Pegol; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegol
Mortality rate is hypothesized to be less than 10% when combining calaspargase pegol with Hyper-CVAD.
Measured: Up to 12 months
Secondary outcomes (3)
Minimal Residual Disease Remission Rate
Minimal Residual Disease (MRD) will be studied as a dichotomous endpoint using a cutoff of 1x10^4 cells/transcripts as the lower limit for residual leukemia and presented as the percentage of patients reaching this landmark as their best response. MRD assessment will be obtained with each bone marrow biopsy assessment, every 3 months in the first year following their last cycle of therapy and every 6 months in the subsequent 2 years following their last cycle.
Measured: Up to 3 years
Progression Free Survival
Progression Free Survival defined as the time from start of treatment to the time of progression or death.
Measured: Up to 42 months
Overall Survival
Overall Survival (OS) will be measured from the initial date of treatment to the recorded date of death.
Measured: Up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 May 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Servier
- Responsible party
- Sponsor
- Investigators
- Bijal Shah, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581030
- Sponsor's protocol ID
- MCC-21213
- Status last verified
- Mar 2026
- First submitted
- 12 Oct 2022
- Last updated
- 6 Mar 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Phase 1b Study of Hyper-CVAD + Calaspargase Pegol in Young Adults With Newly Diagnosed Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05581030
- Acronym / sponsor ID
- MCC-21213
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- A.L.L.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Servier
- Study start
- 1 May 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 14 Oct 2022 (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 purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyper-CVAD + Calaspargase pegol Treatment | Experimental | Drug: Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy), Drug: Calaspargase Pegol, Drug: RituximabParticipants will receive calaspargase pegol administered over 1 hour with each cycle of Hyper-CVAD, mini-CVD, and late intensification, beginning with Cycle 1B. Responding patients will have dose reduction of HyperCVAD for Cycles 2B-4B. Participants with CD20+ ALL will also be given Rituximab once per cycle. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Pathologically confirmed Philadelphia negative B- or T-cell acute lymphoblastic leukemia, with >10% peripheral blood or bone marrow lymphoblasts at diagnosis.
- Treatment and full recovery from arm 1A of the Hyper-CVAD regimen.
- Be willing and able to provide written informed consent/assent for the trial.
- Able to adhere to the study visit schedule and other protocol requirements.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Key exclusion criteria (11 listed)
- Induction therapy with any regimen other than Hyper-CVAD 1A.
- Diagnosis of L3 type Burkitt's lymphoma
- Clinical evidence of active central nervous system (CNS) leukemia.
- Any major surgery or radiation therapy within four weeks.
- Diagnosis of Down Syndrome.
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 |
|---|---|---|
| Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy)Hyper-CVAD consists of two combinations of drugs (courses A and B) given in an alternating fashion. The term "hyper" refers to the hyperfractionated nature of the chemotherapy, which is given in small doses, more frequently, to minimize side effects. CVAD is the acronym of the drugs in course a: cyclophosphamide, vincristine, doxorubicin and dexamethasone. Course A: Cyclophosphamide days 1, 2 and 3. Vincristine days 4 and 11, Doxorubicin day 4, dexamethasone days 1-4 and 11-14, Cytarabine day 7. Mesna is also given orally with cyclophosphamide, to reduce the incidence of haemorrhagic cystitis, a common side effect of cyclophosphamide. Methotrexate, an antimetabolite, may be given when necessary to get chemotherapy past the blood brain barrier. Course B: Methotrexate Day 1 and Cytarabine Days 2 and 3. Dosage is individualized to the patient. | Drug | Hyper-CVAD + Calaspargase pegol Treatment |
| Calaspargase PegolAlso: Asparlas, CalPegCalaspargase pegol 2000 IU/m^2 (capped at 3750 IU) will be administered beginning in cycle 1B of Hyper-CVAD, and will continue at this dose for the duration of the trial. | Drug | Hyper-CVAD + Calaspargase pegol Treatment |
| RituximabAlso: RituxanRituximab 375mg/m^2 will be administered once per cycle for patients with CD20+ ALL. | Drug | Hyper-CVAD + Calaspargase pegol Treatment |
Primary outcome
Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegol
Time frame: Up to 12 months
Mortality rate is hypothesized to be less than 10% when combining calaspargase pegol with Hyper-CVAD.
3 secondary outcomes
Minimal Residual Disease Remission Rate
Time frame: Up to 3 years
Progression Free Survival
Time frame: Up to 42 months
Overall Survival
Time frame: Up to 42 months
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 Mar 2026.
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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.
Bijal Shah, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calaspargase Pegol and Rituximab in people with Acute Lymphoblastic Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute 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 10 inclusion and 11 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 Mar 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegol (time frame: Up to 12 months). 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 Mar 2026.