Chronic Myelocytic Leukemia Clinical Trial
Official title:
An Open Label, Observational Clinical Study to Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Have Any Grade of Adverse Events and Early Molecular Response Within 3 Months of Frontline Dasatinib Therapy
This study is conducted in patients with newly diagnosed CP CML (Chronic Phase Chronic Myeloid Leukemia) who have achieved EMR (< 10% IS BCR-ABL) at 3 months after first line treatment with dasatinib. Subjects will be allocated to 80mg QD based on EMR (Early Molecular Response) achievement and early safety profile following a standard of care approach.
Patients will sign the consent forms for screening prior to frontline dasatinib therapy (1st)
and the 3 month molecular test date (2nd). The molecular samples will be analyzed in the
central lab as part of the screening procedure.
Subjects will be treated for a maximum of 60 months after allocation of the last subject on
the assigned regimen (dasatinib 80mg QD), unless disease progression, treatment failure or
unacceptable toxicity occurs, the subject withdraws consent, or the study is discontinued by
the sponsor. Subjects who discontinue study therapy early due to disease progression or
intolerance to study medication will continue to be followed yearly for survival for up to 5
years after allocation of the last subject. All subjects will be followed yearly for
progression-free survival and overall survival.
For patients who continue their assigned treatment, safety assessments will be conducted
every 6 months and cytogenetic assessment as investigator assessment.
Follow up visits after the last dose of study drug will be required at least every 4 weeks
until all study related toxicities resolve to baseline (or CTC Grade ≤ 1), stabilize or are
deemed irreversible.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01188798 -
Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies
|
Phase 3 | |
| Completed |
NCT00854646 -
Phase I Study of ON 01910.Na in Refractory Leukemia or Myelodysplastic Syndrome (MDS)
|
Phase 1 | |
| Active, not recruiting |
NCT02975115 -
Evaluating True PCR-negative Rate of Frontline Dasatinib in Early Chronic Phase CML for Therapeutic Harmonization
|
N/A | |
| Recruiting |
NCT04256317 -
A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML
|
Phase 2/Phase 3 | |
| Terminated |
NCT01300611 -
TXA127 in Enhancement of Engraftment in Adult Double Cord Blood Transplantation
|
Phase 1 | |
| Terminated |
NCT01621477 -
T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant
|
Phase 2 |