Trial · NCT00001941

Anti-Tac for Treatment of Leukemia

NCT00001941, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2012-08-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Anti-Tac for Treatment of Leukemia. Trials, record NCT00001941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001941

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Trial

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

Title: Anti-Tac for Treatment of Leukemia
NCT number: NCT00001941
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 34 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: HTLV-I Infection, T Cell Leukemia
Interventions: daclizumab
First posted: 2000-01-19
Last updated: 2012-08-20
Results first posted: 2012-08-09
Limitations and caveats: Study was closed to accrual since the cessation of the production of daclizumab.

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Duration of Response	21-220 weeks	Duration of response was defined as the interval from the time response is first achieved to the time progression from the best response is detected. Responses are assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of \>=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; stable disease is patients who did not meet the criteria; and progressive disease is a \>=25% increase in leukemic cell count.
Primary	Overall Survival	132.6 weeks	Measured from the time the patient is consented until death.
Primary	Percentage of Participants With an Overall Response Rate	up to 220 weeks	Participants overall response rate was defined as complete response (CR) + partial response (PR) from study consent until progression was measured. Responses was assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of \>=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; and progressive disease is a \>=25% increase in leukemic cell count
Primary	Number of Participants With Adverse Events	12 months	Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

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	Duration of Response	21-220 weeks	Phase I is not reported because phase I studies only determine maximum tolerated dose.	Weeks	MEDIAN
PRIMARY	Overall Survival	132.6 weeks	Phase I is not reported because phase I studies only determine maximum tolerated dose.	Weeks	MEDIAN
PRIMARY	Percentage of Participants With an Overall Response Rate	up to 220 weeks	Phase I is not reported because phase I studies only determine maximum tolerated dose.	Percentage of participants	NUMBER
PRIMARY	Number of Participants With Adverse Events	12 months	Data is not available separately per cohort.	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	Spread	Units
Duration of Response	Phase II- 8 mg/kg Cohort	114	Full Range 21 to 220	Weeks
Overall Survival	Phase II- 8 mg/kg Cohort	132.6	95% Confidence Interval 53.9 to NA	Weeks
Percentage of Participants With an Overall Response Rate	Phase II- 8 mg/kg Cohort	20		Percentage of participants
Number of Participants With Adverse Events	Phase I & II Cohorts (2-8 mg/kg)	32		Participants

Source ClinicalTrials.gov

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase I - 2 mg/kg Cohort	3
Overall Study	STARTED	Phase I - 4 mg/kg Cohort	5
Overall Study	STARTED	Phase I - 6 mg/kg Cohort	3
Overall Study	STARTED	Phase I - 8 mg/kg Cohort	3
Overall Study	STARTED	Phase II- 8 mg/kg Cohort	20
Overall Study	COMPLETED	Phase I - 2 mg/kg Cohort	3
Overall Study	COMPLETED	Phase I - 4 mg/kg Cohort	5
Overall Study	COMPLETED	Phase I - 6 mg/kg Cohort	3
Overall Study	COMPLETED	Phase I - 8 mg/kg Cohort	3
Overall Study	COMPLETED	Phase II- 8 mg/kg Cohort	19

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events57

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	Amylase	Investigations	Phase II- 8 mg/kg Cohort	4	34	25
other	CPK (creatine phosphokinase)	Investigations	Phase II- 8 mg/kg Cohort	1	34	1
other	Leukocytes (total white blood count (WBC))	Investigations	Phase II- 8 mg/kg Cohort	4	34	24
other	Lymphopenia	Investigations	Phase II- 8 mg/kg Cohort	3	34	13
other	Neutrophils/granulocytes (absolute neutrophil count (ANC)/absolute granulocyte count (AGC))	Investigations	Phase II- 8 mg/kg Cohort	4	34	22
other	Partial thromboplastin time (PTT)	Investigations	Phase II- 8 mg/kg Cohort	1	34	1
other	Myalgia (muscle pain)	Musculoskeletal and connective tissue disorders	Phase II- 8 mg/kg Cohort	2	34	2
other	Edema	General disorders	Phase II- 8 mg/kg Cohort	1	34	1
other	Flatulence	Gastrointestinal disorders	Phase II- 8 mg/kg Cohort	1	34	1
other	Hemoglobin	Investigations	Phase II- 8 mg/kg Cohort	2	34	2

1 to 10 of 57Source ClinicalTrials.gov

See all 57 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase II- 8 mg/kg Cohort
Total, other adverse events	Phase II- 8 mg/kg Cohort	32	34
Total, serious adverse events	Phase II- 8 mg/kg Cohort	1	34

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1172191	BACKGROUND	PubMed
1869828	BACKGROUND	PubMed
3060441	BACKGROUND	PubMed
6343125	BACKGROUND	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.

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/NCT00001941

GET https://conductscience.org/api/trials/v1/NCT00001941/events?page=2

API reference For AI assistants