Trial · NCT00410423

Study of VELCADE® With Mitoxantrone and Etoposide for Leukemias

NCT00410423, Phase 1, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University; results first posted 2018-04-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of VELCADE® With Mitoxantrone and Etoposide for Leukemias. Trials, record NCT00410423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00410423

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of VELCADE® With Mitoxantrone and Etoposide for Leukemias
NCT number: NCT00410423
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 55 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Conditions: Relapsed Acute Leukemia, Refractory Acute Leukemia
Interventions: Bortezomib with mitoxantrone, etoposide and cytarabine, Bortezomib 1.0mg/m^2, Bortezomib 1.3mg/m^2
First posted: 2006-12-12
Last updated: 2025-04-30
Results first posted: 2018-04-17

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Dose Limiting Toxicity in Phase I	30-90 days	Dose limiting toxicity (DLT) is defined as grade-3 toxicity definitely related to bortezomib or grade-4 toxicity probably or definitely related to bortezomib.
Primary	Complete Response Rate to 1.3mg/m^2 of Bortezomib With Mitoxantrone and Etoposide in Phase II	Up to 7 years	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. The percentage of participants that experienced complete response will be 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
PRIMARY	Number of Participants With Dose Limiting Toxicity in Phase I	30-90 days		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Complete Response Rate to 1.3mg/m^2 of Bortezomib With Mitoxantrone and Etoposide in Phase II	Up to 7 years		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Dose Limiting Toxicity in Phase I	Phase 1 - Bortezomib 0.7mg/m^2	0	Participants
Number of Participants With Dose Limiting Toxicity in Phase I	Phase 1 - Bortezomib 1.0 mg/m^2	0	Participants
Number of Participants With Dose Limiting Toxicity in Phase I	Phase 1 - Bortezomib 1.3mg/m^2	0	Participants
Complete Response Rate to 1.3mg/m^2 of Bortezomib With Mitoxantrone and Etoposide in Phase II	Phase 2 - Bortezomib 1.3mg/m^2	27	percentage of participants

Source ClinicalTrials.gov

Participant flow48

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase 1 - Dose Level 1	STARTED	Phase 1 - Bortezomib 0.7mg/m^2	3
Phase 1 - Dose Level 1	STARTED	Phase 1 - Bortezomib 1.0 mg/m^2	0
Phase 1 - Dose Level 1	STARTED	Phase 1 - Bortezomib 1.3 mg/m^2	0
Phase 1 - Dose Level 1	STARTED	Phase 2 - Bortezomib 1.3mg/m^2	0
Phase 1 - Dose Level 1	COMPLETED	Phase 1 - Bortezomib 0.7mg/m^2	3
Phase 1 - Dose Level 1	COMPLETED	Phase 1 - Bortezomib 1.0 mg/m^2	0
Phase 1 - Dose Level 1	COMPLETED	Phase 1 - Bortezomib 1.3 mg/m^2	0
Phase 1 - Dose Level 1	COMPLETED	Phase 2 - Bortezomib 1.3mg/m^2	0
Phase 1 - Dose Level 1	NOT COMPLETED	Phase 1 - Bortezomib 0.7mg/m^2	0
Phase 1 - Dose Level 1	NOT COMPLETED	Phase 1 - Bortezomib 1.0 mg/m^2	0

1 to 10 of 48Source ClinicalTrials.gov

See all 48 participant flow

Adverse events166

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	General disorders	Bortezomib	10	38	11
other	Achiness	General disorders	Bortezomib	2	38	2
other	Acute infusion reaction	General disorders	Bortezomib	7	38	13
other	Allergic reaction	General disorders	Bortezomib	3	38	7
other	Alopecia	General disorders	Bortezomib	6	38	6
other	Anorexia	General disorders	Bortezomib	16	38	19
other	Anxiety	Psychiatric disorders	Bortezomib	8	38	8
other	Arm pain	General disorders	Bortezomib	3	38	4
other	Ataxia	Nervous system disorders	Bortezomib	1	38	1
other	Atrial fibrillation	Cardiac disorders	Bortezomib	2	38	2

1 to 10 of 166Source ClinicalTrials.gov

See all 166 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bortezomib
Total, other adverse events	Bortezomib	38	38
Total, serious adverse events	Bortezomib	10	38

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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