Trial · NCT01319981

Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia

NCT01319981, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2022-09-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia. Trials, record NCT01319981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01319981

On this page

Trial

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

Title: Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia
NCT number: NCT01319981
Status: Completed
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Leukemia
Interventions: Rituximab, Imatinib, Cyclophosphamide, Doxorubicin, Mesna, VSLI, Solu-Medrol, Methotrexate, Ara-C, G-CSF, Pegfilgrastim, Dexamethasone
First posted: 2011-03-22
Last updated: 2022-09-27
Results first posted: 2022-09-27

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Number of Patients With Complete Remission at One Year	1 year	The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of \</=5% blasts in the bone marrow, with \>1x10\^9/L neutrophils, \>100x10\^9/L platelets in the perpherial blood, and no extramedullary disease.
Primary	Overall Survival	Up to 7 years, 8 months	Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.
Primary	Complete Response Duration	Up to 7 years, 8 months	The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of \</=5% blasts in the bone marrow, with \>1x10\^9/L neutrophils, \>100x10\^9/L platelets in the perpherial blood, and no extramedullary disease. Response date to loss of response or last follow up. Remission duration will be measured by the estimated median remission duration computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative remission duration drops below 50%, if present. If not present then median remission duration is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis..

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	Number of Patients With Complete Remission at One Year	1 year		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Overall Survival	Up to 7 years, 8 months	Median not reached due to insufficient number of participants with events.	Months	MEDIAN
PRIMARY	Complete Response Duration	Up to 7 years, 8 months	Of the 15 participants in the Hyper-CMAD + Rituximab arm, only 14 responded and are evaluable for Complete Remission Duration (CRD).	Months	MEDIAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Number of Patients With Complete Remission at One Year	Hyper-CMAD + Rituximab	12		Participants
Number of Patients With Complete Remission at One Year	Hyper-CMAD	13		Participants
Overall Survival	Hyper-CMAD + Rituximab	NA	Full Range 0.3 to 92	Months
Overall Survival	Hyper-CMAD	NA	Full Range 4.4 to 92	Months
Complete Response Duration	Hyper-CMAD + Rituximab	NA	Full Range 6.6 to 92	Months
Complete Response Duration	Hyper-CMAD	NA	Full Range 3.4 to 92	Months

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Hyper-CMAD + Rituximab	15
Overall Study	STARTED	Hyper-CMAD	16
Overall Study	COMPLETED	Hyper-CMAD + Rituximab	15
Overall Study	COMPLETED	Hyper-CMAD	16
Overall Study	NOT COMPLETED	Hyper-CMAD + Rituximab	0
Overall Study	NOT COMPLETED	Hyper-CMAD	0

Source ClinicalTrials.gov

Adverse events256

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	Hyper-CMAD + Rituximab ALL Ph -	1	4	1
other	Abdominal Pain	General disorders	Hyper-CMAD + Rituximab ALL Ph +	0	11	0
other	Abdominal Pain	General disorders	Hyper-CMAD ALL Ph +	0	10	0
other	Abdominal Pain	General disorders	Hyper-CMAD ALL Ph -	0	6	0
other	Activated Partial Thromboplastin Time Prolonged	Investigations	Hyper-CMAD + Rituximab ALL Ph -	0	4	0
other	Activated Partial Thromboplastin Time Prolonged	Investigations	Hyper-CMAD + Rituximab ALL Ph +	0	11	0
other	Activated Partial Thromboplastin Time Prolonged	Investigations	Hyper-CMAD ALL Ph +	0	10	0
other	Activated Partial Thromboplastin Time Prolonged	Investigations	Hyper-CMAD ALL Ph -	1	6	1
other	Acute Kidney Injury	Renal and urinary disorders	Hyper-CMAD + Rituximab ALL Ph -	0	4	0
other	Acute Kidney Injury	Renal and urinary disorders	Hyper-CMAD + Rituximab ALL Ph +	0	11	0

1 to 10 of 256Source ClinicalTrials.gov

See all 256 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Hyper-CMAD + Rituximab ALL Ph -	4	4
Total, all-cause mortality	Hyper-CMAD + Rituximab ALL Ph +	0	11
Total, all-cause mortality	Hyper-CMAD ALL Ph +	0	10
Total, all-cause mortality	Hyper-CMAD ALL Ph -	0	6
Total, other adverse events	Hyper-CMAD + Rituximab ALL Ph -	4	4
Total, other adverse events	Hyper-CMAD + Rituximab ALL Ph +	7	11
Total, other adverse events	Hyper-CMAD ALL Ph +	7	10
Total, other adverse events	Hyper-CMAD ALL Ph -	4	6
Total, serious adverse events	Hyper-CMAD + Rituximab ALL Ph -	2	4
Total, serious adverse events	Hyper-CMAD + Rituximab ALL Ph +	6	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Hyper-CMAD + Rituximab vs Hyper-CMAD: Number of Patients With Complete Remission at One Year

Source Trial comparisons

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.

GET https://conductscience.org/api/trials/v1/NCT01319981

GET https://conductscience.org/api/trials/v1/NCT01319981/events?page=2

API reference For AI assistants