Trial · NCT01574274
SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma
NCT01574274, Phase 2, Active not recruiting, Dana-Farber Cancer Institute; results first posted 2022-09-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma. Trials, record NCT01574274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01574274
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma
- NCT number
- NCT01574274
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 240 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
- Interventions
- SC-PEG, Oncaspar
- First posted
- 2012-04-10
- Last updated
- 2026-07-28
- Results first posted
- 2022-09-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Asparaginase-Related Toxicity | 30-week post-induction asparaginase treatment period. Toxicities assessed on an ongoing basis (at least 1 per month) while participant is on study, an average of 2 years. | Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), symptomatic pancreatitis (grade 2 or worse), thrombotic or bleeding complications requiring intervention (grade 2 or worse) with treatment attribution of possibly, probably or definite based on Common Terminology Criteria for Adverse Events (CTCAE) v4. |
| Primary | Induction and Post-Induction Nadir Serum Asparaginase Activity Level | Samples for nadir serum asparaginase activity levels were assayed at 4,11,18,and 25 days after 1st dose, and then prior to asparaginase dose given during post-induction, at Week 7, 13, 19, and 25. | Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. |
| Secondary | Frequency of Infections | 2 years | Number of episodes of bacteremia, fungemia and invasive fungal infections during the remission induction phase |
| Secondary | Outcome | 2 years | Rates of complete remission, relapse, induction death, remission death, and second malignant neoplasms in participants |
| Secondary | Outcome of Participants With Very-high Risk Disease | 2 years | Rates of relapse, remission death and second malignant neoplasm in participants with high minimal residual disease (MRD) and/or high risk cytogenetics who are treated with a more intensified regimen |
| Secondary | Feasibility of Vitamin D Screening/Supplementation | 2 years | Vitamin D-levels at various times during treatment, proportion of participants with low vitamin D levels, proportion of participants who agree to Vitamin D supplementation |
| Secondary | Feasibility of Prospective Screening for ABGD | 2 years | Number of samples from participants with T-ALL in which a successful result was obtained by quantitative polymerase chain reaction (qPCR) to assess absence of biallelic TCRy deletions (ABGD); frequency of ABGD in T-ALL |
| Secondary | Feasibility of Prospective Screening for Genetic Abnormalities | 2 years | Number of samples from participants with B-ALL in which a successful result was obtained in prospective screening for abnormalities (eg, mutations, deletions, rearrangements) of IKZF1, CRLF2 and JAK1/2 in patients with newly diagnosed B-ALL; proportion of participants with B-ALL found to have one of these abnormalities. |
| Secondary | Relationship Between Apoptotic/Anti-apoptotic Proteins and Response to CT | 2 years | Levels of pro- and anti-apoptotic proteins in participant samples from diagnosis; correlation of these levels to clinical response (induction failure, high MRD, relapse). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Asparaginase-Related Toxicity | 30-week post-induction asparaginase treatment period. Toxicities assessed on an ongoing basis (at least 1 per month) while participant is on study, an average of 2 years. | The analysis dataset is comprised of all patients who received post-induction asparaginase. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Induction and Post-Induction Nadir Serum Asparaginase Activity Level | Samples for nadir serum asparaginase activity levels were assayed at 4,11,18,and 25 days after 1st dose, and then prior to asparaginase dose given during post-induction, at Week 7, 13, 19, and 25. | The analysis dataset is comprised of all randomized patients who consented to research studies with an evaluable sample for analysis of serum asparaginase activity at the respective induction and post-induction assessment timepoints. | IU/mL | MEDIAN |
| SECONDARY | Frequency of Infections | 2 years | |||
| SECONDARY | Outcome | 2 years | |||
| SECONDARY | Outcome of Participants With Very-high Risk Disease | 2 years | |||
| SECONDARY | Feasibility of Vitamin D Screening/Supplementation | 2 years | |||
| SECONDARY | Feasibility of Prospective Screening for ABGD | 2 years | |||
| SECONDARY | Feasibility of Prospective Screening for Genetic Abnormalities | 2 years | |||
| SECONDARY | Relationship Between Apoptotic/Anti-apoptotic Proteins and Response to CT | 2 years |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Asparaginase-Related Toxicity | SC-PEG (Arm A) | 41 | Participants | ||
| Number of Participants With Asparaginase-Related Toxicity | Oncaspar (Arm B) | 43 | Participants | ||
| Induction and Post-Induction Nadir Serum Asparaginase Activity Level | SC-PEG (Arm A) | Day 4 NSAA Level | 0.975 | Full Range 0.430 to 1.499 | IU/mL |
| Induction and Post-Induction Nadir Serum Asparaginase Activity Level | Oncaspar (Arm B) | Day 4 NSAA Level | 1.045 | Full Range 0.069 to 1.731 | IU/mL |
| Induction and Post-Induction Nadir Serum Asparaginase Activity Level | SC-PEG (Arm A) | Day 11 NSAA Level | 0.571 | Full Range 0.156 to 1.176 | IU/mL |
| Induction and Post-Induction Nadir Serum Asparaginase Activity Level | Oncaspar (Arm B) | Day 11 NSAA Level | 0.673 | Full Range 0.025 to 1.224 | IU/mL |
| Induction and Post-Induction Nadir Serum Asparaginase Activity Level | SC-PEG (Arm A) | Day 18 NSAA Level | 0.394 | Full Range 0.080 to 0.887 | IU/mL |
| Induction and Post-Induction Nadir Serum Asparaginase Activity Level | Oncaspar (Arm B) | Day 18 NSAA Level | 0.314 | Full Range 0.025 to 0.536 | IU/mL |
| Induction and Post-Induction Nadir Serum Asparaginase Activity Level | SC-PEG (Arm A) | Day 25 NSAA Level | 0.319 | Full Range 0.025 to 0.549 | IU/mL |
| Induction and Post-Induction Nadir Serum Asparaginase Activity Level | Oncaspar (Arm B) | Day 25 NSAA Level | 0.056 | Full Range 0.025 to 0.079 | IU/mL |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SC-PEG (Arm A) | 119 | |
| Overall Study | STARTED | Oncaspar (Arm B) | 121 | |
| Overall Study | Evaluable for Induction Events | SC-PEG (Arm A) | 115 | |
| Overall Study | Evaluable for Induction Events | Oncaspar (Arm B) | 115 | |
| Overall Study | Achieved Complete Remission | SC-PEG (Arm A) | 109 | |
| Overall Study | Achieved Complete Remission | Oncaspar (Arm B) | 114 | |
| Overall Study | Received Post-induction Asparaginase | SC-PEG (Arm A) | 109 | |
| Overall Study | Received Post-induction Asparaginase | Oncaspar (Arm B) | 114 | |
| Overall Study | Eligible | SC-PEG (Arm A) | 119 | |
| Overall Study | Eligible | Oncaspar (Arm B) | 120 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events390
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | SC-PEG (Arm A) | 1 | 119 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Oncaspar (Arm B) | 0 | 120 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | SC-PEG (Arm A) | 55 | 119 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Oncaspar (Arm B) | 57 | 120 | |
| other | Cardiac disorders - Other, specify | Cardiac disorders | SC-PEG (Arm A) | 1 | 119 | |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Oncaspar (Arm B) | 0 | 120 | |
| other | Left ventricular systolic dysfunction | Cardiac disorders | SC-PEG (Arm A) | 2 | 119 | |
| other | Left ventricular systolic dysfunction | Cardiac disorders | Oncaspar (Arm B) | 0 | 120 | |
| other | Sinus tachycardia | Cardiac disorders | SC-PEG (Arm A) | 3 | 119 | |
| other | Sinus tachycardia | Cardiac disorders | Oncaspar (Arm B) | 2 | 120 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SC-PEG (Arm A) | 7 | 119 |
| Total, all-cause mortality | Oncaspar (Arm B) | 5 | 120 |
| Total, other adverse events | SC-PEG (Arm A) | 118 | 119 |
| Total, other adverse events | Oncaspar (Arm B) | 120 | 120 |
| Total, serious adverse events | SC-PEG (Arm A) | 35 | 119 |
| Total, serious adverse events | Oncaspar (Arm B) | 27 | 120 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SC-PEG (Arm A) vs Oncaspar (Arm B): Number of Participants With Asparaginase-Related Toxicity | Trial comparisons |
| SC-PEG (Arm A) vs Oncaspar (Arm B): deaths from any cause | Trial comparisons |
| SC-PEG (Arm A) vs Oncaspar (Arm B): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01574274
GET https://conductscience.org/api/trials/v1/NCT01574274/events?page=2