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A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT
Phase 1 trial testing Ipilimumab in Acute Myeloid Leukemia in 25 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 10 July 2019 |
| Primary completion | 24 May 2024 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across United States |
Dana-Farber Cancer Institute
18 and older, any sex, with Acute Myeloid Leukemia or Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary objective of this study is to determine the safety (MTD) of CD25/Treg-depleted donor lymphocyte infusion (DLI) plus Ipilimumab in patients with myeloid relapse after matched-HCT. Participants will be evaluated for dose limiting toxicities (DLTs) at day 43. DLTs explained within section 5.4 of the protocol.
| Group | Value | 95% CI |
|---|---|---|
| CD25/Treg-depleted DLI | 30000000 |
The primary objective of this study is to determine the safety (MTD) of CD25/Treg-depleted donor lymphocyte infusion (DLI) plus Ipilimumab in patients with myeloid relapse after matched-HCT. Participants will be evaluated for dose limiting toxicities (DLTs) at day 43. DLTs explained within section 5.4 of the protocol.
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab | 1 |
Complete remission will be evaluated for each disease, along with duration of complete remission. AML morphological complete remission can be found in Appendix E (E.1.1.), and Relapse from CR/CRi is in E.1.3. MDS/MPN complete remission criteria is found in Appendix F (F.1.1), and criteria for relapse is found in F.1.5.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 8 | |
| Dose Level: 1 | 4 | |
| Dose Level: 2 | 0 |
Duration of time from start of treatment to time of objective disease progression or death, whichever comes first. AML progressive disease is defined in Appendix E (E.1.7.), and criteria for MDS/MPN is in Appendix F (F.1.4.).
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 50 | 27 – 73 |
| Dose Level: 1 | 83 | 53 – 100 |
| Dose Level: 2 | NA | NA – NA |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 33 | 11 – 55 |
| Dose Level: 1 | 17 | 0 – 47 |
| Dose Level: 2 | NA | NA – NA |
Duration of time from start of treatment to time of death.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 89 | 75 – 100 |
| Dose Level: 1 | 100 | NA – NA |
| Dose Level: 2 | NA | NA – NA |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 61 | 37 – 83 |
| Dose Level: 1 | 67 | 29 – 100 |
| Dose Level: 2 | NA | NA – NA |
Incidence of aGVHD will be measured at the below time point, and grading severity of aGVHD will be standardized using the chart and information in Appendix C.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 2 | |
| Dose Level: 1 | 2 | |
| Dose Level: 2 | 1 |
Provider will assess study subject for severity of cGVHD per 2014 NIH consensus criteria at day 92.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 7 | |
| Dose Level: 1 | 1 | |
| Dose Level: 2 | 0 |
Severity of aGVHD will be measured at the below time point, and grading severity of aGVHD will be standardized using the chart and information in Appendix C per Harris et al, 2016 "GVHD Target Organ Staging", where 0 is no GVHD and 4 is severe. For the data table below: Grade I-IV reports any incidence of aGVHD, Grade II-IV reports the number of subjects who developed grade II, III, and IV aGVHD and Grade III-IV reports the number of subjects who developed Grade III and IV aGHVD. Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin without liver, upper GI, or lower GI involvement. Grad
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 2 | |
| Dose Level: 1 | 2 | |
| Dose Level: 2 | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 0 | |
| Dose Level: 1 | 1 | |
| Dose Level: 2 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 2 | |
| Dose Level: 1 | 1 | |
| Dose Level: 2 | 1 |
Provider will assess study subject for severity of cGVHD per 2014 NIH consensus criteria at day 92.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 2 | |
| Dose Level: 1 | 1 | |
| Dose Level: 2 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 3 | |
| Dose Level: 1 | 0 | |
| Dose Level: 2 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level: 0 | 2 | |
| Dose Level: 1 | 0 | |
| Dose Level: 2 | 0 |
Time frame: Adverse Events (AEs) are reported from the initial dose of study treatment through to 90 days after the last dose of treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Dose Level: 0 | Dose Level: 1 | Dose Level: 2 |
|---|---|---|---|---|
| Fever | General disorders | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Encephalopathy | Nervous system disorders | — | — | — |
| Obstruction gastric | Gastrointestinal disorders | — | — | — |
| Gastric hemorrhage | Gastrointestinal disorders | — | — | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | — | — | — |
| Reaction | System | Dose Level: 0 | Dose Level: 1 | Dose Level: 2 |
|---|---|---|---|---|
| Fatigue | General disorders | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — |
| White blood cell decreased | Investigations | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Blood lactate dehydrogenase increased | Investigations | — | — | — |
| Immune system disorders - Other, specify | Immune system disorders | — | — | — |
| Alkaline phosphatase increased | Investigations | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — |
| Lipase increased | Investigations | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — |
| Creatinine increased | Investigations | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — |
| Hyperuricemia | Metabolism and nutrition disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — | — | — |
| Hypotension | Vascular disorders | — | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Oral pain | Gastrointestinal disorders | — | — | — |
| Fever | General disorders | — | — | — |
| Bacteremia | Infections and infestations | — | — | — |
| Enterocolitis infectious | Infections and infestations | — | — | — |
| Upper respiratory infection | Infections and infestations | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — |
| CPK increased | Investigations | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — |
Most-reported serious reactions: Fever, Colitis, Respiratory Failure, Encephalopathy, Obstruction gastric, Gastric hemorrhage, Gastrointestinal disorders - Other, specify, Pneumonitis.
Data from ClinicalTrials.gov NCT03912064 adverse events section.
In this research study, our main goal for the ipilimumab portion of the study is to determine the highest dose of ipilimumab that can be given safely in several courses and to determine what side effects are seen in patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Myeloproliferative Neoplasms (MPN), Chronic Myelomonocytic Leukemia (CMML), or Myelofibrosis (MF).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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