Imatinib for Cytomegalovirus Prophylaxis and Treatment After Allogeneic Hematopoietic Stem Cell Transplantation

NCT ID: NCT03343600

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-09
• Study Completion Date: 2019-08-31

Brief Summary

This study aim at examining whether blocking platelet-derived growth factor receptor-α by imatinib lowers the risk of post-allogeneic hematopoietic stem cell transplantation CMV infection.

Detailed Description

This is a randomized, double-blind, multicenter phase II clinical trial. In the trial, post-allo-HSCT patients with signs of bone marrow engraftment and without evidence of CMV reactivation will be enrolled. All enrolled patients will be monitored for their blood CMV DNA copy numbers by Q-PCR and safety throughout the trial. In addition to their routine post-allo-HSCT care, eligible patients will receive imatinib (100mg/tablet, 2 tablets daily) or placebo (2 tablets daily) administration after myeloid engraftment (defined as absolute neutrophil count higher than 500 for three consecutive days). While receiving the trial therapy, patients will have a regular CMV surveillance every week by the quantification of plasma CMV DNA copies. During the administration of the investigational drugs, other concomitant anti-CMV prophylaxis treatments are prohibited. When a patient has any signs suggesting CMV infection that the treating physician determines that an anti-CMV therapy is indicated, the patient will be defined as failure of prophylaxis for the efficacy evaluation. Whether the conventional anti-CMV therapy is started or not, the investigational drugs with imatinib or placebo will be continued till at least Day+100 unless the patient is defined as prophylaxis failure or withdraws from the study including personal reasons, early mortality, disease recurrence after transplantation, pregnancy, or the investigator decides that the subject should be withdrawn for safety reasons or physical conditions.

Conditions

Patients Who Have Received Allo-HSCT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Imatinib

Imatinib (100 mg/tablet) 2# per day till D+100 after allo-HSCT or prophylaxis failure.

Group Type: EXPERIMENTAL

Imatinib

Intervention Type: DRUG

Imatinib 100 mg/tablet, 2 tablets daily

Placebo

Placebo 2# per day till D+100 after allo-HSCT or prophylaxis failure.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebos 2 tablets daily

Interventions

Imatinib

Imatinib 100 mg/tablet, 2 tablets daily

Intervention Type: DRUG

Placebo

Placebos 2 tablets daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients (Age ≧ 20) who received the first allo-HSCT are eligible;
• Patients with underlying disease of acute leukemia in morphological remission, or myelodysplastic syndrome;
• Received allo-HSCT with HLA-matched sibling or unrelated donors (at least 8/8 match for HLA-A/B/C/DR);
• Evidence of post-transplantation neutrophil engraftment: absolute neutrophil count > 500/mm3 for at least 3 consecutive days;
• No detectable CMV infection before study enrollment: negative plasma CMV DNA surveillance within passing 2 weeks;
• No previous post-transplantation anti-CMV therapy and no planned prophylactic anti-CMV therapy;
• The patients has the ability to swallow tablets

Exclusion Criteria

• They have renal insufficiency: serum creatinine > 2.5 mg/dL;
• They have hepatic dysfunction: serum alanine or aspartate aminotransferase levels of > 5 times the upper limit of the normal range or a serum total bilirubin of > 3 mg/dL;
• Patients with history of HIV infection;
• Unstable post-BMT condition or other medical condition deemed not appropriate to be included to this study as judged by investigator;
• Life expectancy less than 3 months;
• Unwillingness or unable to give consent;
• Patients with diseases that are positive for t(9;22) or BCR-ABL fusion gene.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: collaborator

Tri-Service General Hospital

OTHER

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: collaborator

Hualien Tzu Chi General Hospital

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chien-Ting Lin, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Tzu Chi General Hospital

Hualien City, , Taiwan

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

National Cheng Kung Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201707076MIPB

Identifier Type: -

Identifier Source: org_study_id