Trials / Recruiting

RecruitingNCT05581030

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 · Academic / Other
Sex: All
Age: 18 Years – 50 Years
Healthy volunteers: Not accepted

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.

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

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05581030. Inclusion in this directory is not an endorsement.