Trial · NCT00274781
Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes
NCT00274781, Phase 2, Completed, The Cleveland Clinic; results first posted 2015-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes. Trials, record NCT00274781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00274781
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes
- NCT number
- NCT00274781
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Interventions
- arsenic trioxide, gemtuzumab ozogamicin
- First posted
- 2006-01-11
- Last updated
- 2015-07-10
- Results first posted
- 2015-07-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML) | at 12 weeks post treatment | The null hypothesis to be tested was the percentage who will respond to combination arsenic trioxide (ATO) and gemtuzumab ozogamicin (GO) therapy is \<10%. A total of \>/= 9 responses observed in 30 evaluable patients was taken as evidence warranting further study of the regimen, provided the toxicity profile also appears favorable. The IWG Criteria standardizes the clinical responses in MDS and AML based upon hematologic improvement, quality of life and cytogenic improvement. These standardizations allow for the responses to be determined as either complete responses or partial responses. |
| Secondary | Overall Survival | From date of enrollment to a minimum of three years for survival | Patient's Overall Survival from date of enrollment to a minimum of three years for survival. |
| Secondary | Tolerability | 12 Weeks | Tolerability of Therapy was assessed through use of the National Cancer Institute Common Toxicity Criteria (version 3.0). Treatment tolerability was determined based upon whether or not the physician determined therapy was in the patient's best interest, whether the patient wanted to continue therapy or not, whether patients discontinued treatment due to progressive disease, or whether patients discontinued treatment due to toxicity. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML) | at 12 weeks post treatment | Responses According to IWG MDS Criteria (n=30) Responses According to IWG AML Criteria (n=12) | percentage of patients | NUMBER |
| SECONDARY | Overall Survival | From date of enrollment to a minimum of three years for survival | months | MEDIAN | |
| SECONDARY | Tolerability | 12 Weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML) | ATO + GO | Responses according to IWG MDS Criteria | 30 | percentage of patients | |
| Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML) | ATO + GO | Responses according to IWG AML Criteria | 25 | percentage of patients | |
| Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML) | ATO + GO | Responses according to Both Criteria | 10 | percentage of patients | |
| Overall Survival | ATO (0.25mg/kg) and GO (3mg/m2) | Overall Survival | 9.7 | Full Range .75 to 38 | months |
| Overall Survival | ATO (0.25mg/kg) and GO (3mg/m2) | Responders Overall Survival | 28.6 | Full Range 3.5 to 38 | months |
| Overall Survival | ATO (0.25mg/kg) and GO (3mg/m2) | Nonresponders Overall Survival | 7.6 | Full Range 0.75 to 38 | months |
| Tolerability | ATO (0.25mg/kg) and GO (3mg/m2) | Patients Who Completed 1 12-Week Cycle (C1) | 17 | participants | |
| Tolerability | ATO (0.25mg/kg) and GO (3mg/m2) | Patients Who Completed 2 12-Week Cycles (C2) | 7 | participants | |
| Tolerability | ATO (0.25mg/kg) and GO (3mg/m2) | Discontinue Tx During C1: Patient/Physician Choice | 5 | participants | |
| Tolerability | ATO (0.25mg/kg) and GO (3mg/m2) | Discontinue Tx During C1: Progressive Disease | 5 | participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ATO (0.25mg/kg) and GO (3mg/m2) | 30 | |
| Overall Study | COMPLETED | ATO (0.25mg/kg) and GO (3mg/m2) | 30 | |
| Overall Study | NOT COMPLETED | ATO (0.25mg/kg) and GO (3mg/m2) | 0 |
Source ClinicalTrials.gov
Adverse events33
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 | Thrombocytopenia | Vascular disorders | ATO (0.25mg/kg) and GO (3mg/m2) | 16 | 30 | |
| other | Neutropenia | Blood and lymphatic system disorders | ATO (0.25mg/kg) and GO (3mg/m2) | 20 | 30 | |
| other | Anemia | Blood and lymphatic system disorders | ATO (0.25mg/kg) and GO (3mg/m2) | 22 | 30 | |
| other | Fatigue | Musculoskeletal and connective tissue disorders | ATO (0.25mg/kg) and GO (3mg/m2) | 28 | 30 | |
| other | Rash / Pruritis | Skin and subcutaneous tissue disorders | ATO (0.25mg/kg) and GO (3mg/m2) | 12 | 30 | |
| other | Pain | Musculoskeletal and connective tissue disorders | ATO (0.25mg/kg) and GO (3mg/m2) | 16 | 30 | |
| other | Edema | Blood and lymphatic system disorders | ATO (0.25mg/kg) and GO (3mg/m2) | 9 | 30 | |
| other | Nausea / Vomiting / Dyspepsia | Gastrointestinal disorders | ATO (0.25mg/kg) and GO (3mg/m2) | 18 | 30 | |
| other | Diarrhea / Constipation | Gastrointestinal disorders | ATO (0.25mg/kg) and GO (3mg/m2) | 20 | 30 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | ATO (0.25mg/kg) and GO (3mg/m2) | 15 | 30 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATO (0.25mg/kg) and GO (3mg/m2) | ||
| Total, other adverse events | ATO (0.25mg/kg) and GO (3mg/m2) | 28 | 30 |
| Total, serious adverse events | ATO (0.25mg/kg) and GO (3mg/m2) | 19 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA043703 | Case Comprehensive Cancer Center Support Grant | SCHWARTZ, GARY K | CASE WESTERN RESERVE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1987 to 2025 |
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/NCT00274781
GET https://conductscience.org/api/trials/v1/NCT00274781/events?page=2