CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Phase 1
Recruiting
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- Drug: Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy)
- Registration Number
- NCT05581030
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- 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.
- 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
Exclusion Criteria
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hyper-CVAD + Calaspargase pegol Treatment Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy) 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. Hyper-CVAD + Calaspargase pegol Treatment Rituximab 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. Hyper-CVAD + Calaspargase pegol Treatment Calaspargase Pegol 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.
- Primary Outcome Measures
Name Time Method Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegol Up to 12 months Mortality rate is hypothesized to be less than 10% when combining calaspargase pegol with Hyper-CVAD.
- Secondary Outcome Measures
Name Time Method Overall Survival Up to 42 months Overall Survival (OS) will be measured from the initial date of treatment to the recorded date of death.
Progression Free Survival Up to 42 months Progression Free Survival defined as the time from start of treatment to the time of progression or death.
Minimal Residual Disease Remission Rate Up to 3 years 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.
Trial Locations
- Locations (1)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States