Trial · NCT01104025

Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis

NCT01104025, Phase 2, Completed, Children's Hospital Medical Center, Cincinnati; results first posted 2020-10-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis. Trials, record NCT01104025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01104025

On this page

Trial

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

Title: Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis
NCT number: NCT01104025
Status: Completed
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Conditions: Hemophagocytic Lymphohistiocytosis
Interventions: ATG, rabbit, Etoposide, Methotrexate, hydrocortisone, Dexamethasone
First posted: 2010-04-15
Last updated: 2020-10-19
Results first posted: 2020-10-19
Limitations and caveats: This is a single arm study.

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Overall Survival	8 Weeks	To determine the overall survival of patients with hemophagocytic lymphohistiocytosis at 8 weeks after an ATG/etoposide-based induction regimen and to determine the feasibility of this approach in the context of a multicenter clinical trial.
Secondary	Time to Response	8 Weeks	To determine the median time to complete response during 8 weeks of therapy
Secondary	Overall Survival	up to day 180	To determine overall survival prior to the initiation of BMT (bone marrow transplant) preparative regimen (or day 180, if BMT preparative regimen not yet begun)
Secondary	Number of Participants Who Experienced Reactivation	up to 180 days	To determine the frequency of disease reactivation prior to initiation of BMT preparative regimen (or day 180, if BMT preparative regimen not yet begun)
Secondary	Overall Survival to Day +100	up to day 280	To determine overall survival to day +100 after BMT, for patients who have undergone BMT within 6 months of study entry
Secondary	Disease Status at BMT	up to day 180	To determine the rate of complete response at the time of BMT preparative regimen initiation

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	8 Weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Response	8 Weeks	Patients assessed for disease features and classified each week per definition of complete response in order to determine the time at which they achieved complete response.	weeks	MEDIAN
SECONDARY	Overall Survival	up to day 180		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Experienced Reactivation	up to 180 days	all patients surviving to BMT or day 180 and achieving complete or partial response	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival to Day +100	up to day 280		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Disease Status at BMT	up to day 180		Participants	COUNT_OF_PARTICIPANTS

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
Overall Survival	Induction Therapy	25		Participants
Time to Response	Induction Therapy	4	Full Range 2 to 7	weeks
Overall Survival	Induction Therapy	22		Participants
Number of Participants Who Experienced Reactivation	Induction Therapy	4		Participants
Overall Survival to Day +100	Induction Therapy	9		Participants
Disease Status at BMT	Induction Therapy	8		Participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Treatment Period	STARTED	Induction Therapy	31
Treatment Period	COMPLETED	Induction Therapy	25
Treatment Period	NOT COMPLETED	Induction Therapy	6
Follow up Until BMT OR 6 Months	STARTED	Induction Therapy	25
Follow up Until BMT OR 6 Months	COMPLETED	Induction Therapy	22
Follow up Until BMT OR 6 Months	NOT COMPLETED	Induction Therapy	3
Follow up Until Day 100 Post BMT	STARTED	Induction Therapy	11
Follow up Until Day 100 Post BMT	COMPLETED	Induction Therapy	9
Follow up Until Day 100 Post BMT	NOT COMPLETED	Induction Therapy	2

Source ClinicalTrials.gov

Adverse events12

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	fever	Immune system disorders	Induction Therapy	30	31	40
other	anemia	Blood and lymphatic system disorders	Induction Therapy	31	31	31
other	hemorrhage	Blood and lymphatic system disorders	Induction Therapy	5	31	5
other	hypertension	Vascular disorders	Induction Therapy	3	31	3
other	thrombosis	Blood and lymphatic system disorders	Induction Therapy	2	31	2
serious	hospitalization	Blood and lymphatic system disorders	Induction Therapy	7	31	8
serious	respiratory failure	Respiratory, thoracic and mediastinal disorders	Induction Therapy	4	31	4
serious	acute kidney injury	Renal and urinary disorders	Induction Therapy	3	31	3
serious	status epilepticus	Nervous system disorders	Induction Therapy	1	31	1
serious	multiple organ failure	Vascular disorders	Induction Therapy	4	31	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Induction Therapy	11	31
Total, other adverse events	Induction Therapy	31	31
Total, serious adverse events	Induction Therapy	22	31

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.

GET https://conductscience.org/api/trials/v1/NCT01104025

GET https://conductscience.org/api/trials/v1/NCT01104025/registered

API reference For AI assistants