CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

May 1, 2023

Primary Completion Date

June 29, 2025

Study Completion Date

October 31, 2025

Conditions
Acute Lymphoblastic Leukemia
Interventions
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.

Trial Locations (1)

33612

Moffitt Cancer Center, Tampa

All Listed Sponsors
collaborator

Servier

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER