RecruitingPhase 1NCT05581030

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

7 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia

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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CalPeg — a form of the enzyme PEG-asparaginase — in people with newly diagnosed acute lymphoblastic leukemia (ALL), a type of blood cancer. It is being tested as part of a specific chemotherapy regimen (Hyper-CVAD) to see if it is safe and effective. **You may be eligible if...** - You have been diagnosed with Philadelphia chromosome-negative B-cell or T-cell ALL - You have already completed the first part of Hyper-CVAD chemotherapy (Arm 1A) and recovered from it - Your heart function is normal (ejection fraction at least 50%) - Your liver and kidney function are within acceptable ranges - You are willing and able to follow the study schedule **You may NOT be eligible if...** - You have Philadelphia chromosome-positive ALL - You are pregnant or breastfeeding - Your liver or kidney function is significantly impaired - You had a prior severe reaction to asparaginase-type drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHyper 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.

DRUGCalaspargase Pegol

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.

DRUGRituximab

Rituximab 375mg/m\^2 will be administered once per cycle for patients with CD20+ ALL.

Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT05581030

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