Effect of Prophylactic TKI Therapy Post-transplants on Ph+ ALL Undergoing Allo-HSCT With MRD Positive Pre-transplants

NCT03624530 | Unknown Phase 2 DMC

• 1 other identifier: TKI post-HSCT- MRD+Ph+ALL-2018
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) in early first complete remission improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Relapse remains a major cause of treatment failure even after allo-HSCT. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Our previous clinical trial (ID: NCT01883219) demonstrated that pre-emptive tyrosine kinase inhibitor (TKIs) administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ ALL. Moreover, our result suggested that Ph+ ALL with MRD positive pre-transplants had the higher rate of molecular biology relapse. In this study, we will evaluate the safety and efficacy of prophylactic TKI therapy post-transplants on Ph+ ALL undergoing allo-HSCT with MRD positive pre-transplants.

Conditions

Philadelphia Chromosome Positive Acute Lymphocytic Leukemia; Tyrosine Kinase Inhibitor; Minimal Residual Disease; Allogeneic Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Overall survival(OS)

  the time from the date of transplantation to death or the last day of follow-up

  2 year

Secondary Outcomes (3)

• Relapse rate

  2 year

• Disease-free survival(DFS)

  2 year

• Adverse effects of TKI therapy

  2 year

Study Arms (2)

Prophylactic TKI Therapy

EXPERIMENTAL

Treatment with prophylactic TKI will be initiated from day +30 to +60 post-transplants. TKI was selected according to the mutation results of ABL kinase region.

Drug: Tyrosine kinase inhibitor (TKIs)

No TKI therapy

NO INTERVENTION

Prophylactic TKI will not be given.

Interventions

Tyrosine kinase inhibitor (TKIs) DRUG

TKI was selected according to the mutation results of ABL kinase region. Imatinib was initiated at a dose of 200mg/d, dasatinib at a dose of 50mg/d, and ponatinib at a dose of 30mg/d. Then increase the dosage of TKI gradually and increase to therapeutic dose within one month. The duration of TKI was 180 days.

Prophylactic TKI Therapy

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age of 14-65 years
• Ph+ ALL undergoing allo-HSCT with MRD positive pre-transplants
• Survival \> 30 days post-transplants
• MRD negative on day +30 post-transplants

You may not qualify if:

• Ph+ ALL undergoing allo-HSCT with MRD negative pre-transplants
• Survival \<30 days post-transplants
• MRD positive on day +30 post-transplants
• Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
• Patients with any conditions not suitable for the trial (investigators' decision)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Peking University People's Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Guangzhou First People's Hospital: collaborator
• Zhujiang Hospital: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Neoplasm, Residual

Interventions

Tyrosine Kinase Inhibitors

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Qifa Liu

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Xuan

CONTACT

+86-020-62787883; 356135708@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 10, 2018
• Study Start: August 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

CN (1)