ACTIVE_NOT_RECRUITING

CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-05-01

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05581030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Principal Investigator

Bijal Shah, MD

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Bijal Shah, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-01

Study Completion Date2025-10

Study Record Updates

Study Start Date2023-05-01

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

A.L.L.

Additional Relevant MeSH Terms

Acute Lymphoblastic Leukemia