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Janus Kinase (JAK) Inhibitor

Itacitinib for Blood Cancer

Phase 1

Recruiting

Led By Ivana Gojo, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligible diagnoses: Acute leukemias in complete remission with minimal residual disease, Myelodysplastic syndrome (MDS) with at least one poor-risk feature, Chronic myelomonocytic leukemia with at least one poor-risk feature, T-cell PLL in PR or better prior to transplantation, Tyrosine kinase-refractory CML in first chronic phase, TKI-intolerant CML in first chronic phase, or CML in second or subsequent chronic phase, Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis), Multiple myeloma or plasma cell leukemia with a PR or better to the last treatment regimen, Age ≥ 60 years, Adequate end-organ function as measured by: Left ventricular ejection fraction ≥ 35% or shortening fraction > 25%, Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST ≤ 5 x ULN, FEV1 and FVC ≥ 40% of predicted, ECOG performance status ≤ 2 or Karnofsky score ≥ 60

Presence of a suitable related, HLA-haploidentical (partially mismatched) stem cell donor

Must not have

No known HIV infection

No previous allogeneic HSCT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether a new drug could help prevent complications in "mini" transplants for blood cancer patients. It may also reduce the need for other drugs.

Who is the study for?

This trial is for older patients (60+) with various blood cancers like leukemia, myelodysplastic syndrome, and multiple myeloma. They must be in remission or have responded to treatment and have a partially matched related stem cell donor. Key requirements include good heart and liver function, adequate breathing capacity, and an acceptable level of physical fitness.

What is being tested?

Researchers are testing Itacitinib as an immunosuppressant before and after 'mini' stem cell transplants from relatives to prevent complications like cytokine release syndrome in blood cancer patients. The study also aims to see if it can shorten the need for other immune suppressive drugs post-transplant.

What are the potential side effects?

Itacitinib may cause side effects such as lowering the body's ability to fight infections, potential liver issues, changes in blood counts leading to increased bleeding or bruising risk, fatigue, headaches, high blood pressure, nausea or vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You are eligible if you have certain types of leukemia, myelodysplastic syndrome, myeloproliferative disease, or multiple myeloma and meet specific age and organ function requirements.

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I have a family member who can donate stem cells to me.

Exclusion Criteria

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

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I do not have HIV.

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I have not had a bone marrow transplant from another person.

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I do not have any infections that aren't responding to treatment.

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I do not have an active hepatitis B or C infection needing treatment.

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My cancer has not spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participant deaths

Number of participants with grade 1-2 CRS that requires additional CRS-directed treatment

Number of participants with grade 3 or higher CRS

+1 more

Side effects data

From 2020 Phase 3 trial • 439 Patients • NCT03139604

34%

Thrombocytopenia

29%

Anaemia

25%

Oedema peripheral

22%

Hyperglycaemia

21%

Hypertension

20%

Diarrhoea

19%

Hypokalaemia

18%

Platelet count decreased

18%

Nausea

17%

Neutropenia

16%

Cytomegalovirus viraemia

16%

Pyrexia

15%

Cough

14%

Alanine aminotransferase increased

14%

Hypertriglyceridaemia

13%

Dyspnoea

13%

Fatigue

13%

Hypomagnesaemia

13%

Tremor

12%

Cytomegalovirus infection reactivation

12%

Abdominal pain

12%

Blood creatinine increased

12%

Constipation

11%

Decreased appetite

11%

Arthralgia

11%

Aspartate aminotransferase increased

11%

Dizziness

11%

Muscular weakness

11%

Vomiting

10%

Insomnia

Fall

Headache

Upper respiratory tract infection

Dry eye

Dysuria

Anxiety

Back pain

Hypotension

Blood cholesterol increased

Hyponatraemia

Hypophosphataemia

Pain in extremity

Urinary tract infection

Hypocalcaemia

Neutrophil count decreased

Dry mouth

Cytomegalovirus infection

Hypoalbuminaemia

Pruritus

White blood cell count decreased

Asthenia

Blood alkaline phosphatase increased

Acute kidney injury

Pneumonia

Gamma-glutamyltransferase increased

Oral candidiasis

Rash

Weight decreased

Pancytopenia

Dysgeusia

Dyspepsia

Epstein-Barr virus infection reactivation

Hyperkalaemia

Epistaxis

Febrile neutropenia

Oedema

Rhinorrhoea

Dry skin

Leukopenia

Nasopharyngitis

Neuropathy peripheral

Vision blurred

Cystitis haemorrhagic

Syncope

Sepsis

Graft versus host disease in gastrointestinal tract

Thrombotic microangiopathy

Viral haemorrhagic cystitis

Bronchopulmonary aspergillosis

Adenovirus infection

Escherichia sepsis

Failure to thrive

Malignant neoplasm progression

Ophthalmic herpes zoster

Oral herpes

Pulmonary embolism

Septic shock

Pneumonia influenzal

Myopathy

Steroid diabetes

Pseudomonal sepsis

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Itacitinib Plus Corticosteroids

Placebo Plus Corticosteroids

Total

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ItacitinibExperimental Treatment1 Intervention

Itacitinib will be given at 200 mg orally daily from day -3 to day 90. Itacitinib will be given in conjunction with one of four different regimens for immunosuppression. These 4 regimens are listed in Table 2, Section 5.2 of the protocol. Itacitinib may continue beyond day +90 if there is GVHD. NOTE: If patient develops GVHD requiring treatment after all immune suppression, including itacitinib, is stopped on day +90, the itacitinib will not be restarted and the patient will be treated per standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Itacitinib

2020

Completed Phase 3

~980

0 / 7Eligibility criteria met