Skip to content

Single-arm clinical study of Pomalidomide preemptive treatment for adult B-cell acute lymphocytic leukemia in patients with micro residual disease positive after transplantation

Single-arm clinical study of Pomalidomide preemptive treatment for adult B-cell acute lymphocytic leukemia in patients with micro residual disease positive after transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049767
Enrollment
Unknown
Registered
2021-08-09
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell acute lymphocytic leukemia

Interventions

pomalidomide group:pomalidomide 1mg/day

Sponsors

the Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed adult acute B lymphocytic leukemia; 2. After allogeneic hematopoietic stem cell transplantation; 3. Flow cytometry, leukemia-specific fusion gene quantification, next-generation sequencing and other methods to detect minimal residual disease positive; 4. Aged 18-60 years old, male or female; 5. Hematopoietic reconstruction; 6. Patients without acute graft-versus-host disease of grade 2 or above, or chronic graft-versus-host disease with a score of more than 2 points after transplantation; 7. No serious infection and organ dysfunction after transplantation. 8. Voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Morphology of bone marrow cells suggests relapse; 2. Impaired renal or hepatic function (defined as total bilirubin greater than or equal to 2.5 times the upper limit of normal (ULN), aspartate aminotransferase or alanine aminotransferase greater than or equal to 3.0 times ULN, estimated glomerular filtration The passing rate is less than or equal to 40ml/min); 3. Received other anti-tumor therapy within 28 days of the protocol treatment; 4. Received other immunomodulators after transplantation; 5. Past history of thrombotic diseases; 6. Hypersensitivity to the study drug or contraindications to the use of pomalidomide; 7. Poor compliance.

Design outcomes

Primary

MeasureTime frame
2-year event-free survival;overall survival for 2 years;2-year cumulative recurrence rate;

Secondary

MeasureTime frame
2-year non-recurrent mortality;Incidence of acute and chronic graft versus host disease;Adverse Effects Rate;

Countries

China

Contacts

Public ContactWang Lu, Kong Peiyan

the Second Affiliated Hospital of Army Medical University

408645309@qq.com+86 15011506581

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026