What side effects are associated with this type of intervention?

Common treatments for blood cancers, such as immune checkpoint inhibitors, monoclonal antibodies, and targeted therapies, can have a range of side effects. Immune checkpoint inhibitors may cause patchy hypopigmentation of the skin and hair, as well as alopecia. Monoclonal antibodies targeting specific receptors can lead to partial alopecia, hair curling, and dyspigmentation. Chemotherapy agents often result in more severe alopecia and other cutaneous adverse effects. Ustekinumab, which targets IL-12 and IL-23, has been associated with serious infections and myocardial infarctions in some cases. Overall, these treatments can significantly impact the patient's quality of life and adherence to therapy.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of blood cancers that modulate the immune response. For example, Pembrolizumab, an anti-PD-1 therapy, has been approved for various cancers, including blood cancers, due to its ability to enhance the immune system's response against cancer cells. Additionally, Venetoclax, which targets BCL-2, has been approved for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). While Ustekinumab, which targets IL-12 and IL-23, is being studied for preventing acute graft-versus-host disease post-transplant, it is not yet approved for blood cancers. These treatments reflect a broader trend of leveraging the immune system to combat hematologic malignancies.

What other types of research exist?

Promising novel alternatives to Ustekinumab for blood cancer patients include: <ol> <li>Nonmyeloablative transplantation: A less intensive form of stem cell transplant that reduces toxicity.</li> <li></li> </ol> T-cell immunotherapy: Includes CAR T-cell therapy targeting specific cancer antigens. 3. Natural killer (NK) cell therapy: Utilizes NK cells to target and kill cancer cells. 4. Immune agonists: Agents that stimulate the immune system to attack cancer cells. 5. Monoclonal antibodies: Such as rituximab, obinutuzumab, and others targeting specific cancer cell markers. 6. Vaccination strategies: Cancer vaccines designed to elicit an immune response against cancer cells. 7. Interleukin-21 (IL-21): Under investigation for its role in enhancing immune responses against cancer. 8. BTK inhibitors: Such as ibrutinib, acalabrutinib, and zanubrutinib, particularly for chronic lymphocytic leukemia. 9. Venetoclax: Often combined with obinutuzumab for treating chronic lymphocytic leukemia.

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Monoclonal Antibodies

Ustekinumab for Preventing Graft-versus-Host Disease in Blood Cancer Patients

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

Must not have

Non-myeloablative conditioning regimens or conditioning regimens that use less than 75mg/m^2 of melphalan

Prior allogeneic transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of hct, assessed up to 2 years post-hct

Summary

This trial studies how well ustekinumab works in preventing complications in patients receiving unrelated donor transplants. Ustekinumab helps control the immune system to stop it from attacking the body's tissues. The goal is to protect patients from complications after their transplant. Ustekinumab has been used in the treatment of autoimmune conditions such as psoriasis, psoriatic arthritis, and Crohn's disease.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My treatment plan involves low-intensity or specific dose chemotherapy.

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I have had a transplant from a donor.

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I agree to use birth control or not have sex until 15 weeks after the last dose.

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I have HIV, hepatitis B, or hepatitis C.

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I have a non-cancerous blood condition like sickle cell or aplastic anemia.

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I am receiving ATG for transplant preparation or to prevent graft rejection.

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I have an infection that isn't getting better with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of hct, assessed up to 2 years post-hct

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Grade II-IV acute graft versus host disease (GVHD) survival

Secondary study objectives

Acute GVHD organ staging, overall grading, and classification

Incidence of moderate-severe chronic GVHD

Incidence of non-relapse mortality

+4 more

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172

50%

Upper respiratory infection

27%

Common cold

Skin and subcutaneous tissue disorders

Fracture

Anxiety

Dizziness

Back pain

Urinary tract infection

Rash/Rash Acneiform/Maculo-Papular

Toothache

Hypertension

Pain/Pain in extremity

100%

80%

60%

40%

20%

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

2015

Completed Phase 4

~4080

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for blood cancers often involve immune modulation to control the body's immune response against cancer cells. Ustekinumab, for example, targets interleukins IL-12 and IL-23, which are crucial in the regulation of immune responses. By inhibiting these interleukins, Ustekinumab can reduce inflammation and potentially prevent complications like graft-versus-host disease in transplant patients. This is particularly important for blood cancer patients as it helps in managing the immune system's activity, reducing the risk of the immune system attacking healthy cells, and improving overall treatment outcomes.