Trial · NCT02311998
Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML
NCT02311998, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2023-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML. Trials, record NCT02311998. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02311998
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML
- NCT number
- NCT02311998
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, CD22 Positive, Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Interventions
- Bosutinib, Inotuzumab Ozogamicin
- First posted
- 2014-12-09
- Last updated
- 2023-07-17
- Results first posted
- 2023-07-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Bosutinib All Phase I Participants | At day 28 | Maximum tolerated dose of bosutinib defined as the highest dose level in which \< 2 patients of 6 develop first course dose limiting toxicity (Phase I). Dose levels assessed were dose 1 = 300 mg, dose 2 = 400 mg, and dose 3 = 500 mg. |
| Primary | Number of Participants With a Major Hematologic Response | Up to 6 years, 11 months | Major Hematologic Response i(MaHR) is defined as Complete Response (CR) + Complete Remission without Incomplete Blood Count Recovery (CRi). CR was defined as absence of circulating blasts with bone marrow blasts \<5% and recovery of neutrophil count to ≥1.0 x 10\^9/L and platelet count to ≥100 x10\^9/L. The CRi was defined as meeting criteria for CR except for neutrophil and/or platelet recovery. Response was assessed by bone marrow analysis after each cycle of therapy until attainment of CR/CRi. |
| Secondary | Duration of Response | Up to 6 years, 11 months | Estimated using the method of Kaplan-Meier. Response date to loss of response or last follow up. |
| Secondary | Overall Survival (OS) | Up to 6 years, 11 months | Estimated using the method of Kaplan-Meier. Time from date of treatment start until date of death due to any cause or last Follow-up. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Bosutinib All Phase I Participants | At day 28 | This outcome is only intended for the Phase I arm of this study | Milligrams | NUMBER |
| PRIMARY | Number of Participants With a Major Hematologic Response | Up to 6 years, 11 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response | Up to 6 years, 11 months | Of the 18 participants treated during Phase I, 15 were evaluable for response. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 6 years, 11 months | Months | MEDIAN |
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 |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Bosutinib All Phase I Participants | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 400 | Milligrams | ||
| Number of Participants With a Major Hematologic Response | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 3 | Participants | ||
| Number of Participants With a Major Hematologic Response | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 4 | Participants | ||
| Number of Participants With a Major Hematologic Response | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 | 8 | Participants | ||
| Number of Participants With a Major Hematologic Response | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II | 4 | Participants | ||
| Duration of Response | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 4.1 | Full Range 1.9 to 8.8 | Months | |
| Duration of Response | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 7.7 | Full Range 6.2 to 73.8 | Months | |
| Duration of Response | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 | 27.2 | Full Range 2.1 to 68.9 | Months | |
| Duration of Response | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II | 5.1 | Full Range 0.7 to 8.1 | Months | |
| Overall Survival (OS) | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 8.2 | Full Range 6.8 to 10.7 | Months |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 3 | |
| Overall Study | STARTED | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 6 | |
| Overall Study | STARTED | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 | 9 | |
| Overall Study | STARTED | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II | 4 | |
| Overall Study | COMPLETED | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 3 | |
| Overall Study | COMPLETED | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 6 | |
| Overall Study | COMPLETED | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 | 9 | |
| Overall Study | COMPLETED | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II | 4 | |
| Overall Study | NOT COMPLETED | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 0 | |
| Overall Study | NOT COMPLETED | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events424
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 | Abdominal pain | Gastrointestinal disorders | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 1 | 3 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 3 | 6 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 | 0 | 9 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II | 0 | 4 | 0 |
| other | Alanine aminotransferase increased | Investigations | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 0 | 3 | 0 |
| other | Alanine aminotransferase increased | Investigations | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 0 | 6 | 0 |
| other | Alanine aminotransferase increased | Investigations | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 | 2 | 9 | 2 |
| other | Alanine aminotransferase increased | Investigations | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II | 1 | 4 | 1 |
| other | Alkaline phosphatase increased | Investigations | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 0 | 3 | 0 |
| other | Alkaline phosphatase increased | Investigations | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 0 | 6 | 0 |
1 to 10 of 424Source ClinicalTrials.gov
See all 424 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 3 | 3 |
| Total, all-cause mortality | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 5 | 6 |
| Total, all-cause mortality | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 | 4 | 9 |
| Total, all-cause mortality | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II | 2 | 4 |
| Total, other adverse events | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 3 | 3 |
| Total, other adverse events | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 6 | 6 |
| Total, other adverse events | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 | 8 | 9 |
| Total, other adverse events | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II | 4 | 4 |
| Total, serious adverse events | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 3 | 3 |
| Total, serious adverse events | Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 6 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
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/NCT02311998
GET https://conductscience.org/api/trials/v1/NCT02311998/events?page=2