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Pilot Study to Determine Effects of the Btk Inhibitor PCI-32765 on Leukemia Cell Kinetics and Trafficking, Using Heavy Water Labeling in Subjects With CLL and SLL
Phase 1, PHASE2 trial testing Heavy Water (2H2O) in Leukemia in 30 participants. Completed in 9 August 2018.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 17 December 2012 |
| Primary completion | 9 August 2018 |
| Estimated completion | 9 August 2018 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, any sex, with Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Stable isotopic labeling with deuterated water (2\^H2O) to measure directly the effects of PCI-32765 (ibrutinib) on leukemia cell death in the peripheral blood of participants .
| Group | Value | 95% CI |
|---|---|---|
| Heavy Water + PCI-32765 | 0.18 | 0.0 – 0.7 |
| Group | Value | 95% CI |
|---|---|---|
| Heavy Water + PCI-32765 | 1.5 | 0.0 – 3.0 |
Measurement of the fraction of recently born versus older leukemia cells in the peripheral blood of participants before and during PCI-32765 therapy, to determine the effects of PCI-32765 (ibrutinib) therapy on the birth rates of the leukemia cells.
| Group | Value | 95% CI |
|---|---|---|
| Heavy Water + PCI-32765 | 0.39 | 0.17 – 1.04 |
| Group | Value | 95% CI |
|---|---|---|
| Heavy Water + PCI-32765 | 0.05 | 0.0 – 0.36 |
Time frame: Monthly, for up to 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Heavy Water + PCI-32765 |
|---|---|---|
| Atrial Fibrillation | Cardiac disorders | — |
| Pleural effusions | Respiratory, thoracic and mediastinal disorders | — |
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Gastric hemorrhage | Gastrointestinal disorders | — |
| Hematoma | Vascular disorders | — |
| Lung Infection | Infections and infestations | — |
| Mobitz (tyep)II atrioventricular block | Cardiac disorders | — |
| Nail Infection | Infections and infestations | — |
| Pain Extremity | General disorders | — |
| Pericardial effusion | Cardiac disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Sinusitis | Infections and infestations | — |
| Skin infection | Infections and infestations | — |
| Suicide attempt | Psychiatric disorders | — |
| Syncope | Nervous system disorders | — |
| Reaction | System | Heavy Water + PCI-32765 |
|---|---|---|
| Pain | General disorders | — |
| Fatigue | General disorders | — |
| Diarrhea | General disorders | — |
| Bruising | General disorders | — |
| Dizziness | Nervous system disorders | — |
| Edema | General disorders | — |
| Skin rash | Skin and subcutaneous tissue disorders | — |
| Cardiac Disorders other | Cardiac disorders | — |
| Gastrointestinal other | Gastrointestinal disorders | — |
| Hypertension | Vascular disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Oral Mucositis | Gastrointestinal disorders | — |
| Skin other | Skin and subcutaneous tissue disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Infection | Infections and infestations | — |
| Dyspena | Respiratory, thoracic and mediastinal disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Atrial Fibrillation, Pleural effusions, Neoplasms benign, malignant and unspecified, Gastric hemorrhage, Hematoma, Lung Infection, Mobitz (tyep)II atrioventricular block, Nail Infection.
Data from ClinicalTrials.gov NCT01752426 adverse events section.
The goal of this clinical research study is to learn how PCI-32765 (ibrutinib) may affect the life cycle of blood-cancer cells. Cancer cells will be "labeled" with heavy water to learn about their birth rates and death rates. Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that help cells live and grow. The study drug is designed to inhibit or "block" the activity of a type of kinase that helps blood-cancer cells live and grow. By blocking the activity of this specific kinase, it is possible that the study drug may kill the cancer cells or stop them from growing. Heavy water (2H2O) is a special type of water that is designed to help researchers learn how quickly cancer cells in the body reproduce.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing