Calaspargase Pegol in Adults w/Untreated, Ph-negative B-cell and T cell Acute Lymphoblastic Leukemia

What is the Purpose of this Study?

If you choose to join this study, you will get the study drug during the following study regimen phases: induction, consolidation, interim maintenance, and delayed intensification (in that order). The study drug is given as an infusion (IV).

- Induction Phase: You will receive 3 infusions of the study drug.
- Consolidation Phase: You will receive 2 infusions of the study drug.
- Interim Maintenance Phase: You will receive 1 infusion of the study drug.
- Delayed Intensification Phase: You will receive 2 infusions of the study drug.

You will receive also receive standard chemotherapy at the same time as the study drug.

The study regimen will last approximately 12 -18 months. We will follow up with you for 2 years (approximately 8 phone calls, once every 3 months) to see how you are doing.
What is the Condition Being Studied?
Acute Lymphoblastic Leukemia (ALL)

Who Can Participate in this Study?

Adults ages 22+ who:

- Are diagnosed with ALL

- Have not yet received chemotherapy or radiation therapy

For more information about who can join this study, please contact the study team at 919-660-2077.

Age Group
Adults
Participating Institutions

What is Involved?

We are doing this study to find out if a drug called calaspargase pegol is an effective treatment for ALL in most adults. This study drug is an approved treatment for ALL in children and young adults up to 21 years old. We want to know if it is also beneficial for adults older than 21.

Study Details

Full Title
A Multi-center, Open-label, Single-arm Phase 2/3 Trial Evaluating the Safety and Pharmacokinetics of Calaspargase Pegol for Treatment of Adults Aged 22 To >65 Years with Newly-diagnosed Philadelphia-negative ALL
Principal Investigator
Harry Erba
Instructor in the Department of Medicine

Protocol Number
IRB:
PRO00107787

NCT:
NCT04817761
ClinicalTrials.gov
View on ClinicalTrials.gov