Chronic Myeloid Leukemia Clinical Trial
— TOKINOfficial title:
Safety And Efficacy Of Tyrosine Kinase Inhibitor Cessation For Chronic Myeloid Leukemia Patients With Stable Molecular Response In A Real World Population
This is a single-arm, phase II study to evaluate safety and efficacy of tyrosine kinase inhibitor (TKI) cessation for chronic myeloid leukemia (CML) patients with stable molecular response in a real world population.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 15, 2025 |
Est. primary completion date | November 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria 1. Patients who are 18 years or older 2. Patients have a diagnosis of Philadelphia chromosome- or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR). 3. Prior evidence of a quantifiable BCR-ABL1 transcript by RT-PCR 4. Patients who have been taking TKI for > 36 months. 5. Patients must have a history of stable molecular response, defined as MR4.5 for =24 months, as documented by =3 separate tests performed at least three months apart. 6. Patient must have a current status of complete molecular remission (CMR), defined as MR4.5 (per section 5.1), within 30 days of signing consent. 7. ECOG performance status < 2 8. Patients must have normal marrow function within 30 days of registration, as defined: - Absolute Neutrophil Count (ANC) = 1.5 x 10E9/L - Hemoglobin = 9.0 g/dL - Platelets = 100 x 10E9/L 9. Patients must not have any signs of extramedullary leukemia 10. Patients must have a life expectancy of more than 12 months in the absence of any intervention 11. All participants must be informed of the investigational nature of this study and must sign and give written informed consent 12. Contraception requirements will be as per routine clinical practice. Exclusion Criteria 1. Patients who are unable or unwilling to give their consent to participate to the study. 2. Previous or planned allogeneic stem cell transplantation 3. Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping Imatinib. 4. Patient has received an investigational agent within last 2 years 5. Atypical BCR-ABL transcript not quantifiable by standard RQ-PCR. 6. Patient cannot have had a known interruption of TKI therapy of greater than 14 consecutive days or for a total of 6 weeks in the six months prior to registration. 7. Another primary malignant disease, except those that do not currently require treatment (adequately treated conditions, such as excised skin cancer or cervical intra-epithelial neoplasia would not be considered exclusion criteria. If in doubt, please refer to the Principal Investigator). 8. Any medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study. 9. Active liver disease (e.g., chronic active hepatitis, cirrhosis). 10. Known diagnosis of human immunodeficiency virus (HIV) infection. |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine- McNair Campus | Houston | Texas |
United States | Ben Taub General Hospital | Houston | Texas |
United States | CHI St. Luke's Health Baylor College of Medicine Medical Center | Houston | Texas |
United States | Harris Health System- Smith Clinic | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Molecular relapse (MR) free survival | The Kaplan-Meier method will be used to estimate MR free survival rate at 6 months after TKI cessation with a 95% confidence interval. | From date of TKI cessation to the date of MR or censoring, assessed up to 6 months | |
Secondary | ddPCR of BCR-ABL1 values affecting MR free survival | ddPCR of BCR-ABL1 values (copies/µl) at baseline (just before TKI cessation begins) will be assessed by Cox proportional hazard regression model. | At baseline (just before TKI cessation begins) | |
Secondary | Event free survival (EFS) | The event for EFS is defined as any of the following events: (i) loss of complete hematologic response (CHR), (ii) to accelerated phase or blast crisis (AP/BC), (iii) death due to any cause, whichever occurs first.The Kaplan-Meier method will be used to estimate EFS at 6months and up to 24 months after TKI cessation with a 95% confidence interval. | From date of TKI cessation to the date of the event defined or censoring, assessed at 6 months and up to 24 months | |
Secondary | Progression-free survival (PFS) | The event of progression is defined by AP/BC or death due to any causes, whichever occurs first. The Kaplan-Meier method will be used to estimate PFS at 6 months and up to 24 months after TKI cessation with a 95% confidence interval. | From date of TKI cessation to the date of the progression defined or censoring, assessed at 6 months and up to 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Completed |
NCT02057185 -
Occupational Status and Hematological Disease
|
||
Recruiting |
NCT03326310 -
Selumetinib and Azacitidine in High Risk Chronic Blood Cancers
|
Phase 1 | |
Recruiting |
NCT04621851 -
Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation
|
||
Completed |
NCT01207440 -
Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)
|
Phase 2 | |
Not yet recruiting |
NCT06409936 -
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML
|
Phase 2 | |
Active, not recruiting |
NCT02917720 -
2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients
|
Phase 2 | |
Not yet recruiting |
NCT02883036 -
Vitro Study of Tigecycline to Treat Chronic Myeloid Leukemia
|
N/A | |
Withdrawn |
NCT01188889 -
RAD001 in Patients With Chronic Phase Chronic Myeloid Leukemia w/ Molecular Disease.
|
Phase 1/Phase 2 | |
Completed |
NCT01795716 -
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
|
Phase 1 | |
Completed |
NCT00988013 -
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
|
N/A | |
Approved for marketing |
NCT00905593 -
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
|
Phase 3 | |
Terminated |
NCT00573378 -
Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia
|
Phase 2 | |
Terminated |
NCT00522990 -
Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias
|
Phase 1/Phase 2 | |
Completed |
NCT00469014 -
Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia
|
Phase 2 | |
Unknown status |
NCT00598624 -
Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
|
Phase 2 | |
Completed |
NCT00257647 -
Use of SV40 Vectors to Treat Chronic Myeloid Leukemia (CML)
|
N/A | |
Completed |
NCT00219739 -
STI571 ProspectIve RandomIzed Trial: SPIRIT
|
Phase 3 | |
Completed |
NCT06148493 -
Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database
|
||
Completed |
NCT00375219 -
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
|
Phase 2 |