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NCT01574274 · ClinicalTrials.gov registry record · Phase 2
SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma
A Phase 2 study of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
- 8
- Study locations
NCT01574274 is a Phase 2 study of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 240 participants, below the 380-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (37% lower). The trial reports 8 study locations across 5 states.
The verdict
NCT01574274, a Phase 2 study of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study is being conducted to learn about the effects of SC-PEG, which is a new form of a chemotherapy drug called asparaginase. Asparaginase is used to treat ALL and lymphoblastic lymphoma. The standard form of asparaginase, called Elspar, is given in the muscle once a week for 30 weeks. There are other forms of asparaginase. The investigators will be studying two of these: Oncaspar and Calaspargase Pegol (SC-PEG). The investigators have previously studied giving Oncaspar in the vein (instead of the muscle) every 2 weeks in patients with ALL, and have shown that this dosing did not lead to any more side effects than Elspar given weekly in the muscle. The study drug, SC-PEG, is very similar but not identical to Oncaspar. SC-PEG has been given in the vein to children and adolescents with ALL as part of other research studies, and it appears to last longer in the blood after a dose than Oncaspar. It has not yet been approved by the FDA. The goal of this research study is to learn whether the side effects and drug levels of SC-PEG given in the vein every 3 weeks are similar to Oncaspar given into the vein about every 2 weeks. The study will also help to determine whether changing treatment for children and adolescents with ALL with high levels of minimal residual disease may improve cure rates. Measuring minimal disease (MRD) is a laboratory test that finds low levels of leukemia cells that the investigators cannot see under the microscope. In the past, it has been shown that children and adolescents with ALL with high levels of MRD after one month of treatment are less likely to be cured than those with low levels of MRD. Therefore, on the study, the bone marrow and blood at the end of the first month of treatment will be measured in participants with leukemia, and changes in therapy will be implemented based on this measurement. It is not known for sure that changing treatment will improve cure rates. MRD levels can only be measured if the marrow is filled with c
Conditions Studied
Interventions
- DRUG SC-PEG
- DRUG Oncaspar
Study Locations (8)
Massachusetts
- Children's Hospital Boston - Boston
- Dana-Farber Cancer Institute - Boston
New York
- Columbia University Medical Center, Morgan Stanley Children's Hospital of New York-Presbyterian - New York
- Montefiore Medical Center - New York
Quebec
- Hospital Sainte Justine, University of Montreal - Montreal
- Centre Hospitalier U. de Quebec - Québec
Rhode Island
- Hasbro Children's Hospital - Providence
Ontario
- McMaster University - Hamilton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2012-06 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01574274
The ClinicalTrials.gov registry entry for NCT01574274 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (37% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which SC-PEG is the first listed.
NCT01574274 reports 8 study locations spanning 5 distinct geographic areas - top geographies include Massachusetts, New York, Quebec.
Frequently Asked Questions
What is clinical trial NCT01574274 about?
NCT01574274 is a clinical study titled "SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma". This study is being conducted to learn about the effects of SC-PEG, which is a new form of a chemotherapy drug called asparaginase. Asparaginase is used to treat ALL and lymphoblastic lymphoma. The standard form of asparaginase, called Elspar, is given in the muscle once a week for 30 weeks. There a...
What is the current status of trial NCT01574274?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2012-06. Estimated completion is 2027-07-01.
What conditions does trial NCT01574274 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma.
What interventions are being tested in trial NCT01574274?
The interventions under investigation include: SC-PEG (DRUG), Oncaspar (DRUG).
Who is sponsoring clinical trial NCT01574274?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01574274 being conducted?
This trial has 8 study locations across Massachusetts, New York, Rhode Island, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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