Trial · NCT00492856
S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia
NCT00492856, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2014-07-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia. Trials, record NCT00492856. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00492856
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia
- NCT number
- NCT00492856
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 105 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Leukemia
- Interventions
- mercaptopurine, methotrexate, tretinoin
- First posted
- 2007-06-27
- Last updated
- 2023-01-10
- Results first posted
- 2014-07-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 3-year Disease-free Survival (DFS) Rate | Up to 3 years | DFS measured from date of post-consolidation randomization until relapse of any kind or death from any cause. Observation censored at date of last follow-up for patients last known to be alive without report of relapse. Relapse from CR/CRi is occurrence of marrow blasts ≥ 5% or presence of Auer rods or presence of neoplastic promyelocytes; (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from PR is sum of marrow blasts and promyelocytes ≥ 20%, or sum of marrow blasts and promyelocytes 6-19% with Auer rods and/or neoplastic promyelocytes; or (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from CRc is reappearance of t(15;17) in cytogenetic analysis. Relapse from CRm/PRm is reappearance of PML-RARα by RT-PCR as defined by a normalized quotient \> 10\^-5 based on RT-PCR performed at appropriate central lab. |
| Secondary | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Up to 5 years | Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. Only adverse events that are possibly, probably, or definitely related to study drug are reported. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Up to 5 years | Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries. | Participants | NUMBER |
| PRIMARY | 3-year Disease-free Survival (DFS) Rate | Up to 3 years | Eligible patients in molecular remission after receiving consolidation and randomized to either maintenance chemotherapy or observation. As of 8/15/10, all eligible patients were non-randomly assigned to receive maintenance chemotherapy. Only those that were randomized to either maintenance treatment or observation were included. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group474
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ATRA + Ara-C + Daunorubicin | ALT, SGPT (serum glutamic pyruvic transaminase) | 5 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Consolidation | ALT, SGPT (serum glutamic pyruvic transaminase) | 3 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ATRA+6-MP+MTX | ALT, SGPT (serum glutamic pyruvic transaminase) | 2 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Gemtuzumab Ozogamicin | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ATRA + Ara-C + Daunorubicin | AST, SGOT | 2 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Consolidation | AST, SGOT | 2 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ATRA+6-MP+MTX | AST, SGOT | 1 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Gemtuzumab Ozogamicin | AST, SGOT | 0 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ATRA + Ara-C + Daunorubicin | Acidosis (metabolic or respiratory) | 1 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Consolidation | Acidosis (metabolic or respiratory) | 0 | Participants |
1 to 10 of 474Source ClinicalTrials.gov
See all 474 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | Low and Intermediate Risk APL Patients | 105 | |
| Induction | STARTED | Post-consolidation ATRA, 6-MP, MTX | 0 | |
| Induction | STARTED | Post-consolidation Observation | 0 | |
| Induction | STARTED | Post-consolidation Gemtuzumab Ozogamicin | 0 | |
| Induction | COMPLETED | Low and Intermediate Risk APL Patients | 99 | |
| Induction | COMPLETED | Post-consolidation ATRA, 6-MP, MTX | 0 | |
| Induction | COMPLETED | Post-consolidation Observation | 0 | |
| Induction | COMPLETED | Post-consolidation Gemtuzumab Ozogamicin | 0 | |
| Induction | NOT COMPLETED | Low and Intermediate Risk APL Patients | 6 | |
| Induction | NOT COMPLETED | Post-consolidation ATRA, 6-MP, MTX | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events556
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 | DIC (disseminated intravascular coagulation) | Blood and lymphatic system disorders | ATRA + Ara-C + Daunorubicin | 24 | 105 | |
| other | DIC (disseminated intravascular coagulation) | Blood and lymphatic system disorders | Consolidation | 0 | 90 | |
| other | DIC (disseminated intravascular coagulation) | Blood and lymphatic system disorders | ATRA+6-MP+MTX | 1 | 38 | |
| other | DIC (disseminated intravascular coagulation) | Blood and lymphatic system disorders | Gemtuzumab Ozogamicin | 0 | 1 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | ATRA + Ara-C + Daunorubicin | 62 | 105 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Consolidation | 8 | 90 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | ATRA+6-MP+MTX | 0 | 38 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Gemtuzumab Ozogamicin | 1 | 1 | |
| other | Hemoglobin | Blood and lymphatic system disorders | ATRA + Ara-C + Daunorubicin | 43 | 105 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Consolidation | 59 | 90 |
1 to 10 of 556Source ClinicalTrials.gov
See all 556 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATRA + Ara-C + Daunorubicin | ||
| Total, all-cause mortality | Consolidation | ||
| Total, all-cause mortality | ATRA+6-MP+MTX | ||
| Total, all-cause mortality | Gemtuzumab Ozogamicin | ||
| Total, other adverse events | ATRA + Ara-C + Daunorubicin | 105 | 105 |
| Total, other adverse events | Consolidation | 89 | 90 |
| Total, other adverse events | ATRA+6-MP+MTX | 37 | 38 |
| Total, other adverse events | Gemtuzumab Ozogamicin | 1 | 1 |
| Total, serious adverse events | ATRA + Ara-C + Daunorubicin | 8 | 105 |
| Total, serious adverse events | Consolidation | 4 | 90 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24528179 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00492856
GET https://conductscience.org/api/trials/v1/NCT00492856/results?page=2