Hematological Malignancies Clinical Trial
Official title:
Real Life Assessment of the Association and Its Determinants Between Side Effects and Plasmatic Concentrations of Two Protein Kinase Inhibitors: Ibrutinib (IMBRUVICA®) and Idelalisib (ZYDELIG®) in Hematological Malignancies Treatment.
Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib. Clinical trials for ibrutinib and idelalisib were performed with a small number of patients (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this study is to determine the association between clinically significant side effects occurrence during the first year of treatment and plasma mean concentration of the steady state of ibrutinib or idelalisib at 1 month.
Recently, European medicines agency approved ibrutinib and idelalisib in the treatment of Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib. Nevertheless, clinical trials for these two drugs were performed for only 300-350 patients and showed several side effects profiles, the most frequent were diarrhea, infection, cutaneous rash… For some patients, treatment had to be reduced or stopped temporary or definitely. Pharmacokinetic properties of these two drugs highlight an interindividual pharmacokinetic considerable variability. The aim of this clinical research study is to determine the association between clinically significant side effects occurrence during the first year of treatment (serious adverse reaction and/or grade CTCAE ≥ 3 and/or leading a dosage concession) and plasma mean concentration of the steady state of ibrutinib or idelalisib performed at 1 month. To determine plasma mean concentration of the steady state of ibrutinib or idelalisib, blood tests will be performed every scheduled monitoring at visit 1 month during a pharmacokinetic exploration and during scheduled medical consultation (2, 3, 6 and 12 months) and every unscheduled visit in case of side effect occurrence. Every scheduled monitoring visit, blood tests will be performed to determine plasma concentration in drug. Complementary blood or salivary samples will be collected before the treatment, 24 months later and in case of relapse to determine genetic characteristics. In parallel, a logbook will be completed by the patient to collect side effects. Finally, an oncology certified nurse call patients every 2 weeks. In case of side effect occurrence a visit will be organized in the next 3 days and a blood test will be performed. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03248479 -
Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies
|
Phase 1 | |
| Recruiting |
NCT05454241 -
CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies
|
Phase 2 | |
| Recruiting |
NCT06041815 -
Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
|
||
| Active, not recruiting |
NCT05005442 -
A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
|
Phase 2 | |
| Recruiting |
NCT02300571 -
Observational Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant
|
N/A | |
| Active, not recruiting |
NCT01428973 -
Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens
|
Phase 2 | |
| Completed |
NCT00379587 -
Rituximab for Prevention of Chronic GVHD
|
Phase 1/Phase 2 | |
| Terminated |
NCT00506948 -
Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease (GVHD)
|
Phase 2 | |
| Completed |
NCT01162096 -
Reduced Intensity Haploidentical Transplant for Hematological Malignancies
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04557098 -
A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
|
Phase 2 | |
| Recruiting |
NCT04283097 -
Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects
|
Phase 1 | |
| Completed |
NCT03067155 -
CMV Specific T Cell Therapy After Allogeneic Stem Cell Transplantation.
|
Phase 2 | |
| Completed |
NCT01725555 -
A Study to Assess the Effect of Food on the Bioavailability of the IGF-1R Inhibitor AXL1717 in Patients With Advanced Malignant Tumors
|
Phase 1 | |
| Completed |
NCT00438178 -
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies
|
Phase 1 | |
| Completed |
NCT03711604 -
Compassionate Use Study of Tenalisib (RP6530)
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT01168882 -
Safety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological Malignancies
|
Phase 1 | |
| Completed |
NCT01246206 -
Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT
|
Phase 2 | |
| Completed |
NCT01172132 -
The Use of Intensive Care in Critically Ill Cancer Haematological Patients: "TRIAL-OH"
|
N/A | |
| Completed |
NCT00506402 -
A Phase 1 Study of MKC-1 in Patients With Refractory Hematologic Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT00163644 -
RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT
|
N/A |