Trial · NCT00001575
Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia
NCT00001575, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-12-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia. Trials, record NCT00001575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001575
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia
- NCT number
- NCT00001575
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Hodgkin's Disease, Lymphoma, Non-Hodgkin
- Interventions
- Y-90 Humanized Anti-Tac, Calcium-DTPA
- First posted
- 1999-11-04
- Last updated
- 2015-12-07
- Results first posted
- 2015-12-07
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of 90Y-HAT | Patients could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks. | Phase I portion maximum tolerated dose (MTD) is defined as the dose level below the dose at which 2 out of 2-6 patients develop DLT (if any patient develops grade IV toxicity of any type (excluding grade IV neutropenia) or grade III non-hematologic toxicity that patient may not continue on the study at the same dose level and therefore has had a dose limiting toxicity). There can be no more than 1 out of 6 patients with DLT at the MTD. The MTD will be assessed using only the results from the first cycle of therapy. |
| Primary | Clinical Response | Patient would be measured with computed tomography (CT) scan, Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scan in 28 days before treatment. Patient would be evaluated with In-HAT imaging at Day 1,4,5,6 and Day 7 in week 1 of each cycle. | Clinical Response of patient is measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Tumor responses were evaluated by In-HAT imaging (i.e., simultaneous with administration of therapeutic 90Y-daclizumab), Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scans and computed tomography (CT) scans. Complete response is a disappearance of all measurable and evaluable disease lasting more than I month. Partial response is a reduction by ≥ 50% of leukemic cell count or ≥ 50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesions for 1 month. Stable disease is less than partial response with no more than a 25% increase in leukemic cell count, no new lesions, or less than a 25% increase in any measurable lesion. Progressive disease is at least a 25% increase in leukemic cell count, appearance of new lesions, or an increase of 25% or greater in any measurable lesion after 2 weeks. |
| Secondary | Number of Participants With Adverse Events | 16 yrs 18 days | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
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 | Maximum Tolerated Dose (MTD) of 90Y-HAT | Patients could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks. | Phase I portion-maximum tolerated dose. Only the Hodgkin's participants was analyzed (i.e., 28). | mci | NUMBER |
| PRIMARY | Clinical Response | Patient would be measured with computed tomography (CT) scan, Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scan in 28 days before treatment. Patient would be evaluated with In-HAT imaging at Day 1,4,5,6 and Day 7 in week 1 of each cycle. | Phase II portion. Only the Hodgkin's participants was analyzed (i.e., added more Hodgkins participants to study). | participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events | 16 yrs 18 days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
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 90Y-HAT | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 15 | mci | ||
| Clinical Response | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | Complete Response | 14 | participants | |
| Clinical Response | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | Partial Response | 9 | participants | |
| Clinical Response | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | Stable Disease | 14 | participants | |
| Clinical Response | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | Progressive Disease | 9 | participants | |
| Number of Participants With Adverse Events | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 57 | participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 87 | |
| Overall Study | Treated | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 65 | |
| Overall Study | COMPLETED | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 42 | |
| Overall Study | NOT COMPLETED | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 45 |
Source ClinicalTrials.gov
Adverse events121
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 | ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 1 | 64 | 1 |
| other | ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 2 | 64 | 2 |
| other | ALLERGY/IMMUNOLOGY:: Allergy-Other (Specify, sinus congestion) | Immune system disorders | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 1 | 64 | 1 |
| other | AUDITORY/HEARING:: Auditory/Hearing-Other (Specify, pressure in right ear) | Ear and labyrinth disorders | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 1 | 64 | 1 |
| other | BLOOD/BONE MARROW:: Hemoglobin | Blood and lymphatic system disorders | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 33 | 64 | 109 |
| other | BLOOD/BONE MARROW:: Leukocytes (total WBC) | Blood and lymphatic system disorders | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 32 | 64 | 132 |
| other | BLOOD/BONE MARROW:: Lymphopenia | Blood and lymphatic system disorders | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 37 | 64 | 142 |
| other | BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 15 | 64 | 64 |
| other | BLOOD/BONE MARROW:: Platelets | Blood and lymphatic system disorders | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 37 | 64 | 115 |
| other | BLOOD/BONE MARROW:: Transfusion: Platelets | Blood and lymphatic system disorders | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 1 | 64 | 1 |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | ||
| Total, other adverse events | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 49 | 64 |
| Total, serious adverse events | Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT) | 8 | 64 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT00001575
GET https://conductscience.org/api/trials/v1/NCT00001575/events?page=2