Clinical trial · Interventional
Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation
Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective study of the safety and efficacy of nivolumab for the treatment of relapsed or residual haematological malignancies after allogeneic stem cell transplantation (alloSCT). Eligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. The primary objective is to evaluate the incidence, severity and treatment responsiveness of GVHD following nivolumab treatment post-alloSCT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Haematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab Injection | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab treatment arm
- description
- Nivolumab injection 3mg/kg intravenously every 2 weeks
- interventionNames
- Drug: Nivolumab Injection
Primary outcomes (3)
- measure
- Graft versus host disease
- timeFrame
- 8 weeks
- description
- Cumulative incidence of graft versus host disease
- measure
- Graft versus host disease
- timeFrame
- 24 weeks
- description
- Cumulative incidence of graft versus host disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prior allogeneic stem cell transplant for a haematological malignancy * Confirmed relapse of haematological malignancy or persistent disease post-alloSCT * Immunosuppression cessation for minimum of 2 weeks * Life expectancy \> 2 months * ECOG performance status 0-2 * Greater than or equal to 30% CD3+ donor chimerism * Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 40mL/min * AST and ALT ≤ 3 times upper limit of normal * Total bilirubin ≤ 1.5 times upper limit of normal (except patients with Gilbert Syndrome) * Signed written informed consent Exclusion Criteria: * Current evidence of any grade of GVHD * Prior history of grade 2 or higher acute GVHD * Moderate chronic GVHD within the previous 6 months or any prior history of severe chronic GVHD * Active, known or suspected autoimmune disease (excluding vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger) * Positive hepatitis B virus surface antigen * Positive hepatitis C virus antibody * Known human immunodeficiency virus infection
References
Publications (0)
Data not yet available