Efficacy and Safety of Lenalidomide Combined With Azacitidine vs Azacitidine in the Treatment of MDS-RS

NCT06004765 | Unknown Phase 4

• 1 other identifier: Len+Aza-MDS-RS
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

At present, the main therapies for myelodysplastic syndromes with ring sideroblasts (MDS-RS) are red blood cell and platelet transfusion, erythropoietin (EPO), androgen, and iron chelation therapy. Lenalidomide is an immunomodulator with multiple mechanisms, including direct targeting of MDS clones, immunomodulation, erythropoiesis restoration, and angiogenesis inhibition. A Phase III, randomized, placebo-controlled trial of oral azacitidine (AZA) in lower-risk MDS reported higher rates of hemoglobin and platelet hematological improvement in patients with AZA monotherapy. Therefore, this study intended to investigate the efficacy and safety of lenalidomide and sequential AZA in the treatment of refractory MDS-RS versus azacitidine monotherapy.

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (2)

• overall response rate (ORR)

  Proportion of patients achieved complete response, partial response, and hematological improvement.

  3, 6 months

• complete response rate

  Proportion of patients achieved complete response.

  3, 6 months

Secondary Outcomes (2)

• relapse free survival (RFS)

  3, 6, 12, 24 months

• Overall survival (OS)

  3, 6, 12, 24 months

Study Arms (2)

lenalidomide and sequential azacitidine

EXPERIMENTAL

Lenalidomide (10mg/d \*21 days, 28 days for 1 course), at least 2 courses. If effective, continue to use lenalidomide until ineffective or intolerant. Patients receive azacitidine (75mg/m2/d\*5 days, 28 days for 1 course). Until progression or intolerance. At least 2 sessions of treatment are needed.

Drug: Lenalidomide; Drug: Azacitidine

azacitidine

EXPERIMENTAL

Azacitidine (75mg/m2/d\*5 days, 28 days for 1 course) for at least 4 courses

Drug: Azacitidine

Interventions

Lenalidomide DRUG

10mg/d \*21 days, 28 days for 1 course

lenalidomide and sequential azacitidine

Azacitidine DRUG

75mg/m2/d\*5 days, 28 days for 1 course

azacitidine; lenalidomide and sequential azacitidine

Eligibility Criteria

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

You may qualify if:

• Age \>18 years old.
• Patients with a definite diagnosis of MDS-RS and stratified as lower-risk according to IPSS-R.
• After at least 3 months of rhEPO treatment, with hemoglobin\<90g/L, absolute neutrophil count≥1.0× 109 /L, and platelet≥30× 109 /L
• Unconditional hematopoietic stem cell transplantation
• Adequate hepatic functions with alanine transaminase (ALT)/aspartate. transaminase (AST) levels within 2 times of the normal upper limit and total bilirubin levels within 2 times of the normal upper limit.
• \. No active infection; Not pregnant or breastfeeding 6. ECOG≦2 with an expected life span of more than 6 months 7. Documented patient consent.

You may not qualify if:

• Proliferative (white blood cell count ≥12× 109 /L) chronic myelomonocytic leukemia.
• Complicated with active or uncontrolled infections.
• Complicated with other malignancies.
• Creatinine/transaminase ≥ 2 normal upper limit.
• Complicated with myelofibrosis.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking union medical college hospital

Beijing, China

Location

Related Publications (11)

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MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Lenalidomide; Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Bing Han

CONTACT

13601059938; hanbing_li@sina.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• 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 16, 2023
• First Posted: August 22, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)