Chronic Myeloid Leukemia (CML) Clinical Trial
Official title:
A Phase II, Non Randomized, Open Label, Trial Evaluating Nilotinib as Treatment for Newly Diagnosed CML Patients in Accelerated Phase.
This is an open label, non randomized, prospective, multicenter, phase II clinical trial
evaluating nilotinib 400 mg BID for the treatment of newly diagnosed CML-AP patients.
Patients enrolled into the study will receive 400mg of nilotinib, orally, twice daily
(800mg/day)
Patients will be evaluated for safety throughout the study and for response every month for
the first 3 months, then every 3 months thereafter up to month 24.
BCR-ABL transcripts measurement by QRT-PCR and mutation analyses will be done on peripheral
blood samples and cytogenetic analyses on bone marrow aspirates.
Laboratory tests (hematology, blood chemistry), ECG and physical examination will be done on
every visit.
Drug pharmacokinetics will be assessed in this study. For the screening Baseline periods,
see chart attached
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01066468 -
Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.
|
Phase 1 | |
| Completed |
NCT00428909 -
Effect of Imatinib Mesylate and the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
|
Phase 1 | |
| Completed |
NCT04126707 -
The Absorption, Metabolism and Excretion of [14C] HQP1351 in Humans
|
Phase 1 | |
| Recruiting |
NCT02061800 -
CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT00488592 -
Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers
|
Phase 2 | |
| Terminated |
NCT03615105 -
Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors
|
Phase 2 | |
| Recruiting |
NCT02790515 -
Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation
|
Phase 2 | |
| Active, not recruiting |
NCT03849651 -
TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies
|
Phase 2 | |
| Completed |
NCT02363868 -
Healthcare Costs Among Patients With CML Receiving Dasatinib or Nilotinib in a Commercial and Medicare Population
|
N/A | |
| Completed |
NCT00433745 -
Wilm's Tumor 1 (WT1) Peptide Vaccine for High Risk Hematologic Malignancy
|
Phase 2 | |
| Not yet recruiting |
NCT04709731 -
Cardiovascular Assessment of Ponatinib as Third Line Treatment in Chronic Phase Chronic Myeloid Leukemia
|
Phase 2 | |
| Recruiting |
NCT03481868 -
EPIgenetics and in Vivo Resistance of Chronic Myeloid Leukemia Stem Cells to Tyrosine Kinase Inhibitors
|
N/A | |
| Recruiting |
NCT02889003 -
Second STOP After Pioglitazone Priming in CML Patients
|
Phase 2 | |
| Completed |
NCT02733445 -
Metabolic Outcomes in Patients Receiving Tyrosine Kinase Inhibitor (TKI) Therapy With Dasatinib or Nilotinib
|
N/A | |
| Active, not recruiting |
NCT03746054 -
Evaluation of a Cardiovascular Active Prevention in Chronic Myeloid Leukemia on the Cardiovascular Morbi-mortality
|
Phase 3 | |
| Completed |
NCT01667133 -
A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL)
|
Phase 1/Phase 2 | |
| Completed |
NCT00720785 -
Natural Killer Cells and Bortezomib to Treat Cancer
|
Phase 1 | |
| Recruiting |
NCT05963061 -
Chronic Myeloid Leukemia (CML) Real-Life Database
|
||
| Approved for marketing |
NCT01592136 -
Expanded Access Program of Ponatinib
|
N/A |