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RecruitingPhase 1

CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

A Single-Arm, Open-Label Phase 1b Study of Hyper-CVAD + Calaspargase Pegol in Young Adults With Newly Diagnosed Acute Lymphoblastic Leukemia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe calaspargase pegol is and how well people handle it when given with several chemotherapy drugs. It is for people with newly diagnosed acute lymphoblastic leukemia (ALL) who have finished and fully recovered from the first part of a treatment called Hyper-CVAD.

The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed B-cell or T-cell ALL without the Philadelphia chromosome, a certain gene change. At diagnosis, more than 10% of blood or bone marrow cells must be immature leukemia cells.
  • Have finished and fully recovered from Hyper-CVAD treatment part 1A.
  • Be willing and able to sign the study consent form and follow the visit schedule and study rules.
  • Be fully active or able to do light work. Before Hyper-CVAD part 1A, a heart scan must show that the heart pumps out at least 50% of its blood with each beat.
  • Have bilirubin and creatinine blood levels below 1.5 times the upper normal limit. Liver tests called AST and ALT must be below 3 times that limit.
  • If able to become pregnant, have a negative blood pregnancy test at screening.
  • If able to become pregnant, agree to use two highly effective, non-hormonal birth control methods, be surgically unable to become pregnant, or avoid sex with men during the study and for 3 months after the last dose.
  • Men must use suitable birth control from the first dose until 30 days after the last dose. They must not donate sperm during the study or for 3 months afterward.

Who can't join

  • Have had a starting leukemia treatment other than Hyper-CVAD part 1A.
  • Have L3-type Burkitt's lymphoma, Down syndrome, or signs of active leukemia in the brain or spinal cord.
  • Have had major surgery or radiation treatment within 4 weeks.
  • Have an active infection that needs treatment throughout the body, including HIV or hepatitis B or C.
  • Have a health problem, treatment, or abnormal test result that the study doctor thinks could affect the results, prevent full participation, or make joining unsafe.
  • Have repeated blood clots, or have had a blood clot not linked to a central vein catheter within 3 months before joining.
  • Have another serious illness with an expected survival of less than 6 months, or another active cancer that is uncontrolled or has spread.
  • Be pregnant or breastfeeding, or plan to become pregnant or father a child from screening through 3 months after the last study dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

FL