Phase 3
Completed N=193
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
Source: ClinicalTrials.gov NCT02959944 ↗Enrolled (actual)
193
Serious AEs
52.6%
Results posted
May 2021
Primary outcomePrimary: Primary Analysis: Response Rate at 48 Weeks — 41.1; 36.7 percentage of participants — p=0.5384
◆ Published Evidence
Established
52citations · ~17 / year
Ibrutinib for First-Line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase III iNTEGRATE Study.
Summary
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
Linked Publications
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Ibrutinib for First-Line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase III iNTEGRATE Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Analysis: Response Rate at 48 Weeks |
41.1; 36.7 | 0.5384 |
| PRIMARY Final Analysis: Response Rate at 48 Weeks |
41.1; 36.7 | 0.5384 |
| SECONDARY Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD |
0.042; 0.021; 0.229; 0.216; 0.318; 0.322 | 0.324 |
| SECONDARY Final Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD |
0.042; 0.021; 0.218; 0.219; 0.318; 0.326 | 0.281 |
| SECONDARY Primary Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants |
0.011; 0.000; 0.142; 0.134; 0.220; 0.207 | 0.275 |
| SECONDARY Final Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants |
0.011; 0.000; 0.143; 0.136; 0.222; 0.221 | 0.216 |
| SECONDARY Primary Analysis: Response Rate at 24 Weeks |
47.4; 54.1 | 0.3510 |
| SECONDARY Final Analysis: Response Rate at 24 Weeks |
47.4; 54.1 | 0.3510 |
| SECONDARY Primary Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits |
38.9; 26.5 | 0.0659 |
| SECONDARY Final Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits |
43.2; 30.6 | 0.0708 |
| SECONDARY Primary Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days |
40.0; 45.9 | 0.4064 |
| SECONDARY Final Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days |
41.1; 45.9 | 0.4955 |
| SECONDARY Primary Analysis: Overall Survival (OS) |
NA; NA | — |
| SECONDARY Final Analysis: OS |
NA; NA | — |
| SECONDARY Primary Analysis: Duration of Response (DOR) for Participants Who Had PR or CR at Any Time |
19.8; 10.0 | 0.1010 |
| SECONDARY Final Analysis: DOR for Participants Who Had PR or CR at Any Time |
19.1; 10.2 | 0.1004 |
| SECONDARY Primary Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone |
93; 95; 60; 64; 66; 58 | — |
| SECONDARY Final Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone |
93; 95; 64; 64; 67; 57 | — |
Eligibility Criteria
Key Inclusion Criteria
- New onset moderate or severe cGVHD as defined by the 2014 National Institutes of Health (NIH) Consensus Development Project Criteria
- Need for systemic treatment with corticosteroids for cGVHD
- No previous systemic treatment for cGVHD (including extracorporeal photopheresis [ECP])
- Participants may be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or treatment of acute GVHD it must be at or below 0.5 mg/kg/d
- Age ≥12 years old
- Karnofsky or Lansky (subjects <16 years) performance status ≥60
Key Exclusion Criteria
- Received any previous systemic treatment for cGVHD with the exception of corticosteroids administered for cGVHD within the 72 hours prior to signing the informed consent form.
- Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD
- Any uncontrolled infection or active infection requiring ongoing systemic treatment
- Progressive underlying malignant disease or any post-transplant lymphoproliferative disease
- Known bleeding disorders
- Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
Data sourced from ClinicalTrials.gov (NCT02959944) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.