Trial · NCT00014495
Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
NCT00014495, Phase 1, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2016-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer. Trials, record NCT00014495. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00014495
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
- NCT number
- NCT00014495
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Interventions
- filgrastim, cytarabine, bismuth Bi213 monoclonal antibody M195
- First posted
- 2003-01-27
- Last updated
- 2016-01-22
- Results first posted
- 2016-01-22
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose | 2 years | The maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose | 2 years | mCi/kg | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose | Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine | 1 | mCi/kg |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bismuth-labeled HuM195 (0.5 mCi/kg) | 3 | |
| Overall Study | STARTED | Bismuth-labeled HuM195 (0.75 mCi/kg) | 3 | |
| Overall Study | STARTED | Bismuth-labeled HuM195 (1 mCi/kg) | 20 | |
| Overall Study | STARTED | Bismuth-labeled HuM195 (1.25 mCi/kg) | 6 | |
| Overall Study | COMPLETED | Bismuth-labeled HuM195 (0.5 mCi/kg) | 3 | |
| Overall Study | COMPLETED | Bismuth-labeled HuM195 (0.75 mCi/kg) | 3 | |
| Overall Study | COMPLETED | Bismuth-labeled HuM195 (1 mCi/kg) | 19 | |
| Overall Study | COMPLETED | Bismuth-labeled HuM195 (1.25 mCi/kg) | 5 | |
| Overall Study | NOT COMPLETED | Bismuth-labeled HuM195 (0.5 mCi/kg) | 0 | |
| Overall Study | NOT COMPLETED | Bismuth-labeled HuM195 (0.75 mCi/kg) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events128
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 | Creatinine increased | Investigations | Bismuth-labeled HuM195 (0.5 mCi/kg) | 1 | 3 | 2 |
| other | Creatinine increased | Investigations | Bismuth-labeled HuM195 (0.75 mCi/kg) | 0 | 3 | 0 |
| other | Creatinine increased | Investigations | Bismuth-labeled HuM195 (1 mCi/kg) | 4 | 20 | 7 |
| other | Creatinine increased | Investigations | Bismuth-labeled HuM195 (1.25 mCi/kg) | 1 | 6 | 1 |
| other | Derm, skin other | Skin and subcutaneous tissue disorders | Bismuth-labeled HuM195 (0.5 mCi/kg) | 1 | 3 | 1 |
| other | Derm, skin other | Skin and subcutaneous tissue disorders | Bismuth-labeled HuM195 (0.75 mCi/kg) | 0 | 3 | 0 |
| other | Derm, skin other | Skin and subcutaneous tissue disorders | Bismuth-labeled HuM195 (1 mCi/kg) | 2 | 20 | 2 |
| other | Derm, skin other | Skin and subcutaneous tissue disorders | Bismuth-labeled HuM195 (1.25 mCi/kg) | 0 | 6 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Bismuth-labeled HuM195 (0.5 mCi/kg) | 1 | 3 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Bismuth-labeled HuM195 (0.75 mCi/kg) | 2 | 3 | 3 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bismuth-labeled HuM195 (0.5 mCi/kg) | ||
| Total, all-cause mortality | Bismuth-labeled HuM195 (0.75 mCi/kg) | ||
| Total, all-cause mortality | Bismuth-labeled HuM195 (1 mCi/kg) | ||
| Total, all-cause mortality | Bismuth-labeled HuM195 (1.25 mCi/kg) | ||
| Total, other adverse events | Bismuth-labeled HuM195 (0.5 mCi/kg) | 3 | 3 |
| Total, other adverse events | Bismuth-labeled HuM195 (0.75 mCi/kg) | 3 | 3 |
| Total, other adverse events | Bismuth-labeled HuM195 (1 mCi/kg) | 17 | 20 |
| Total, other adverse events | Bismuth-labeled HuM195 (1.25 mCi/kg) | 6 | 6 |
| Total, serious adverse events | Bismuth-labeled HuM195 (0.5 mCi/kg) | 2 | 3 |
| Total, serious adverse events | Bismuth-labeled HuM195 (0.75 mCi/kg) | 2 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20858843 | RESULT |
Source PubMed
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 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/NCT00014495
GET https://conductscience.org/api/trials/v1/NCT00014495/events?page=2