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Monoclonal Antibodies

Ustekinumab for Blood Cancers

Phase 2
Recruiting
Led By Stephanie J. Lee
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 - 70
Hematologic malignancy or disorder requiring allogeneic hematopoietic cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of hct, assessed up to 2 years post-hct
Awards & highlights

Study Summary

This trial looks at whether ustekinumab can help prevent acute graft versus host disease, which happens when transplanted cells from a donor attack the body's normal tissues.

Who is the study for?
This trial is for adults aged 18-70 with blood cancers or disorders needing a stem cell transplant from an unrelated donor. Participants must have good heart, lung, and liver function, a specific level of physical fitness (Karnofsky Score ≥ 70%), and matched donors. Pregnant women, those with prior transplants, certain non-malignant blood disorders, active infections not under control, HIV/hepatitis B/C infections or unwillingness to use birth control are excluded.Check my eligibility
What is being tested?
The study tests if Ustekinumab can prevent acute graft-versus-host disease after receiving stem cells from an unrelated donor. It compares the effects of Ustekinumab against a placebo in patients undergoing transplantation while monitoring their quality of life through questionnaires.See study design
What are the potential side effects?
Ustekinumab may cause side effects like headaches, tiredness, upper respiratory infections and possibly serious but rare reactions such as severe infections or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I need a bone marrow transplant for my blood cancer or disorder.
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My treatment plan includes a specific intensity of bone marrow preparation.
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I am mostly able to care for myself and carry out daily activities.
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My bone marrow donor is a perfect match for me.
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My stem cell transplant will use cells from my blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of hct, assessed up to 2 years post-hct
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of hct, assessed up to 2 years post-hct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Grade II-IV acute graft versus host disease (GVHD) survival
Secondary outcome measures
Acute GVHD organ staging, overall grading, and classification
Cumulative incidence of grade II-IV and grade III-IV acute GVHD
Incidence of moderate-severe chronic GVHD
+5 more

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172
50%
Upper respiratory infection
27%
Common cold
9%
Urinary tract infection
9%
Anxiety
9%
Back pain
9%
Dizziness
9%
Fracture
9%
Skin and subcutaneous tissue disorders
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Hypertension
5%
Pain/Pain in extremity
5%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (ustekinumab)Experimental Treatment3 Interventions
Between 4 and 72 hours prior to start of HCT conditioning therapy, patients receive ustekinumab IV. Beginning 8 weeks after receiving IV ustekinumab, patients receive ustekinumab SC on days 50 (+/- 5 days), 100 (+/- 7 days), and 160 (+/- 7 days) post-HCT in the absence of grade III-IV acute GVHD, disease relapse or unacceptable toxicity. NOTE: HCT infusion takes place on day 0.
Group II: Arm II (placebo)Placebo Group3 Interventions
Between 4 and 72 hours prior to start of HCT conditioning therapy, patients receive a placebo IV. Beginning 8 weeks after IV placebo, patients receive a placebo SC on days 50 (+/- 5 days), 100 (+/- 7 days), and 160 (+/- 7 days) post-HCT in the absence of grade III-IV acute GVHD, disease relapse, or unacceptable toxicity. NOTE: HCT infusion takes place on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab
2013
Completed Phase 4
~4140

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,256 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,279 Total Patients Enrolled
Stephanie J. LeePrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Media Library

Ustekinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04572815 — Phase 2
Blood Cancers Research Study Groups: Arm II (placebo), Arm I (ustekinumab)
Blood Cancers Clinical Trial 2023: Ustekinumab Highlights & Side Effects. Trial Name: NCT04572815 — Phase 2
Ustekinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04572815 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for participants in the clinical trial?

"Yes, clinicaltrials.gov confirms that this medical study is actively recruiting participants since it was first posted on May 14th 2021 and updated lastly on September 8th 2022. The trial necessitates the enrolment of 116 patients from 5 distinct sites."

Answered by AI

Does the upper age limit for participation in this clinical trial exceed 75 years?

"Inclusion in this clinical trial demands that patients are aged between 18 and 70. An additional 57 studies cater to those below the age of consent, whereas 159 trials focus on people above 65 years old."

Answered by AI

How has Ustekinumab been deemed to be a secure treatment for patients?

"There is evidence of Ustekinumab's safety from Phase 2 trials, resulting in a score of 2. However, no data exists yet to support its efficacy."

Answered by AI

How many parties are involved in the ongoing clinical research?

"In order to fulfill the trial's requirements, 116 individuals who meet all necessary criteria must be enrolled. Those interested can participate from either City of Hope in Duarte, California or City of Hope Comprehensive Cancer Center located in Tampa, Florida."

Answered by AI

What maladies is Ustekinumab routinely employed to alleviate?

"Ustekinumab is a viable solution for treating adrenal cortex hormone deficiency, unresponsiveness to TNF antagonists, and psoriasis."

Answered by AI

In what regions is this research endeavor taking place?

"This clinical trial is accepting participants from several medical centres, such as City of Hope in Duarte and its Comprehensive Cancer Center in Tampa, along with H. Lee Moffitt Cancer Center & Research Institute located in Buffalo. Additionally, there are 3 other sites recruiting patients for this study."

Answered by AI

Who is the ideal candidate for enrolling in this medical study?

"This clinical trial is searching for 116 participants in the age range of 18-70 who possess lymphoid cells. Additionally, they must fulfill the following criteria: Informed consent documentation, FEV1/FVC/DLCO ≥ 50% predicted values on pulmonary tests, Creatinine clearance ≥50 cc/min., KPS score ≥ 70%, PBSC as graft source, Reduced intensity or reduced toxicity conditioning regimens with minimum 75mg/m2 melphalan dose if applicable, LVEF ≥ 50%, Transaminase levels < 3x ULN and an 8/8 HLA match between donor and recipient."

Answered by AI

What other experiments have been done to assess the efficacy of Ustekinumab?

"Currently, 34 clinical trials for Ustekinumab are in progress with 17 of them being Phase 3. Most studies take place in Gdansk, Pomorskie but there is a total of 2820 research sites conducting this study across the world."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ustekinumab for the Prevention of Acute Graft-versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant
2021. "Ustekinumab for the Prevention of Acute Graft-versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04572815.
~38 spots leftby Sep 2025
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