Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease

Conditions

• Chronic GVHD

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ibrutinib — DRUG
  140 mg capsules for a dose of 420 mg daily by mouth for up to 12 months.
• ECG — DIAGNOSTIC_TEST
  At screening.
• PFT's — DIAGNOSTIC_TEST
  Participants should have PFTs if not performed ≤3 months prior to start of study treatment and Cycle 7, Day 1 (6 months). Optional at Cycle 12, Day 28 (12 months) and Cycle 24, Day 28 (24 months).
• CT — DIAGNOSTIC_TEST
  Non-contrast CT at baseline and later during the study if clinically indicated.
• Steroid pulse (prednisone) — DRUG
  0.5-2mg/kg/day allowed for clinical disease stabilization during first 4 weeks after starting Ibrutinib.
• Voriconazole — DRUG
  At any dose.
• Posaconazole — DRUG
  As clinically indicated. At doses less than or equal to suspension 200 mg twice a day (BID) if ibrutinib dose modified to 280 mg once daily. OR Posaconazole suspension 200 mg three times a day (TID) or 400 mg BID if Ibrutinib dose modified to 140 mg once daily. OR Posaconazole injection intravenous (IV) injection 300 mg once daily; or delayed-release capsules 300 mg once daily if Ibrutinib dose modified to 140 mg once daily..
• Azithromycin — DRUG
  Treat or prevent bronchiolitis obliterans.
• Montelukast — DRUG
  Treat or prevent bronchiolitis obliterans.
• Budesonide — DRUG
  Treat or prevent gastrointestinal acute graft-versus host disease (GvHD).
• Beclomethasone — DRUG
  Treat or prevent gastrointestinal acute graft-versus host disease (GvHD).
• Filgrastim — OTHER
  Neutrophil growth factor permitted per institutional policy
• Pegfilgrastim — OTHER
  Neutrophil growth factor permitted per institutional policy.
• Erythropoietin — OTHER
  Red cell growth factor permitted per institutional policy.
• Transfusions — OTHER
  According to institutional policy.
• Oral/Skin biopsy — PROCEDURE
  Optional. Baseline, Cycle 7, Day 1 (6 months), Cycle 12, Day 28 (12 months) and Cycle 24, Day 28.

Study Details

Background: \- Chronic Graft Versus Host Disease (cGVHD) can occur after a person has had a stem cell or bone marrow transplant. In cGVHD, the donor cells attack the recipient's body. Researchers want to see if a drug called ibrutinib can block one of the proteins that lead to the immune reaction that causes cGVHD. Objective: \- To see if ibrutinib as a first-line treatment can help people with newly diagnosed cGVHD. Eligibility: \- People age 18 and older with newly diagnosed moderate or severe cGVHD Design: * Participants will be screened with: * Medical and medicine histories * Physical exam and vital signs * Electrocardiograms (to measure heart function) * Assessment of their ability to perform daily activities * Blood and urine tests * Assessment of their general well-being. * Participants will visit the Clinical Center every 2 weeks for the first 2 months. Then they will visit every 4 weeks. * Participants will take ibrutinib by mouth once every day of every cycle. One cycle is 28 days. Treatment will last up to 2 years. Participants will keep a medicine diary. * Participants will take tests to measure lung function. They may have computed tomography scans of their chest. They will complete questionnaires about their symptoms and how cGVHD is affecting their body and quality of life. They will repeat the screening tests. * Participants may have optional blood tests and/or skin biopsies to better understand the drugs effect on the body. * Participants will be contacted by phone 30 days after treatment ends. They will also be contacted once a year for 2 years to discuss how they are feeling and if they have taken any other medicines to treat cGVHD.

Key Dates

Start date

May 10, 2021

Status verified

Jan 2026

Primary completion

Jun 24, 2024

Completion

Oct 1, 2024

Study Design

Enrollment

10 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ibrutinib Without Corticosteroids
  Determine response rate via continuous daily dose by mouth to determine efficacy

Primary Outcome Measure

Fraction of Participants With an Overall Response Rate (Complete Response [CR] + Partial Response [PR]) Reported With an 80% Confidence Interval at 6 Months [ Time Frame: At 6 months ]

Locations (2)

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