Ustekinumab for Blood Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
City of Hope, Duarte, CABlood Cancer+2 MoreUstekinumab - Biological
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Blood Cancer
  • Hematologic and Lymphocytic Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: From time of HCT, assessed up to 2 years post-HCT

At 6 months post-HCT
Cumulative incidence of grade II-IV and grade III-IV acute GVHD
Month 6
Grade II-IV acute graft versus host disease (GVHD) survival
Year 2
Incidence of moderate-severe chronic GVHD
Incidence of non-relapse mortality
Incidence of overall chronic GVHD
Incidence of post-HCT relapse
Overall survival
Relapse-free survival
Day 100
Acute GVHD organ staging, overall grading, and classification

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Ustekinumab (Stelara)
50%Upper respiratory infection
27%Common cold
9%Back pain
9%Fracture
9%Anxiety
9%Dizziness
9%Urinary tract infection
9%Skin and subcutaneous tissue disorders
5%Toothache
5%Pain/Pain in extremity
5%Rash/Rash Acneiform/Maculo-Papular
5%Hypertension
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT02187172) in the Ustekinumab (Stelara) ARM group. Side effects include: Upper respiratory infection with 50%, Common cold with 27%, Back pain with 9%, Fracture with 9%, Anxiety with 9%.

Trial Design

2 Treatment Groups

Arm I (ustekinumab)
1 of 2
Arm II (placebo)
1 of 2

Experimental Treatment

Non-Treatment Group

116 Total Participants · 2 Treatment Groups

Primary Treatment: Ustekinumab · Has Placebo Group · Phase 2

Arm I (ustekinumab)Experimental Group · 3 Interventions: Ustekinumab, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Biological, Other, Other
Arm II (placebo)PlaceboComparator Group · 3 Interventions: Quality-of-Life Assessment, Questionnaire Administration, Placebo Administration · Intervention Types: Other, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from time of hct, assessed up to 2 years post-hct

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
149,065 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
532 Previous Clinical Trials
1,315,235 Total Patients Enrolled
Stephanie J. LeePrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

Age 18 - 70 · All Participants · 10 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.