Calaspargase Pegol in Adults With ALL
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ClinicalTrials.gov Identifier: NCT04817761 |
Recruitment Status :
Recruiting
First Posted : March 26, 2021
Last Update Posted : February 5, 2024
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Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | March 15, 2021 | ||||||||||||||||||
First Posted Date ICMJE | March 26, 2021 | ||||||||||||||||||
Last Update Posted Date | February 5, 2024 | ||||||||||||||||||
Actual Study Start Date ICMJE | July 7, 2021 | ||||||||||||||||||
Actual Primary Completion Date | December 30, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Calaspargase Pegol in Adults With ALL | ||||||||||||||||||
Official Title ICMJE | 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. | ||||||||||||||||||
Brief Summary | The purpose of this phase 2/3 study is to confirm the recommended doses and to evaluate the safety and pharmacodynamics of Calaspargase pegol for the treatment of adult patients with Philadelphia-negative Acute Lymphoblastic Leukemia. | ||||||||||||||||||
Detailed Description | The study will be conducted in 2 parts. Part 1 is a dose confirmation run-in period. Part 2 will enroll the remaining participants at the dose as confirmed in Part 1. | ||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Acute Lymphoblastic Leukemia | ||||||||||||||||||
Intervention ICMJE | Drug: Calaspargase pegol (S95015)
Part 1: S95015 will be administered at dose of 2000 U/m2, 1500 U/m2 or 1000 U/m2 (dose level based on age and BMI) via a 2-hour intravenous infusion at Day 4 (or 5, or 6) of the induction phase, Days 15 and 43 of the consolidation phase, Day 22 of the interim maintenance phase and Days 4 (or 5, or 6) and 43 of the delayed intensification phase. S95015 starting doses for age and BMI groups will be confirmed. Patients will receive premedication prior to calaspargase pegol administration (acetaminophen, histamine-1 blocker, and corticosteroids to prevent hypersensitivity reaction) and other backbone chemotherapy agents based on the CALGB 10403 protocol treatment regimen. Part 2: Patients aged 22 to 39 years + BMI ≤ 35 kg/m2 will be treated with S95015 1750 U/m2. Patients aged 40 to < 55 years + BMI ≤ 35 kg/m2 will be treated with S95015 1500 U/m2, unchanged from Part 1. Patients 55 years or older or those with a BMI greater than 35 kg/m2 will no longer be enrolled into Part 2. |
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Study Arms ICMJE | Experimental: Calaspargase pegol (S95015)
Intervention: Drug: Calaspargase pegol (S95015)
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||||
Estimated Enrollment ICMJE |
122 | ||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
Estimated Study Completion Date ICMJE | February 2027 | ||||||||||||||||||
Actual Primary Completion Date | December 30, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 22 Years to 55 Years (Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||||||
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Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT04817761 | ||||||||||||||||||
Other Study ID Numbers ICMJE | CL2-95015-001 | ||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Servier ( Institut de Recherches Internationales Servier ) | ||||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||||
Current Study Sponsor ICMJE | Institut de Recherches Internationales Servier | ||||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||||
Collaborators ICMJE | ADIR, a Servier Group company | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | Servier | ||||||||||||||||||
Verification Date | February 2024 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |