Aza With or Without ATRA in Newly Diagnosed Unfit AML or Intermediate,High or Very High Risk MDS

Soochow University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: AML; MDS; Hematologic Cancer; Old Age; Debility

Treatments: Drug: all trans retinoic acid; Drug: Azacitidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05175508

SOOCHOW-HY-2021-03

Details and patient eligibility

About

This is a randomized, open-label, multicenter study to compare the efficacy and safety of AZA with or without ATRA in newly diagnosed unfit AML or Intermediate,High or Very High Risk MDS

Full description

Newly diagnosed unfit AML and Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria are unable to tolerate the intensive chemo-therapy regimens due to their old age and poor physical condition, resulting in limited overall survival. Nowadays, AZA are recommended for unfit acute myeloid leukemia or myelodysplastic syndromes patients with remission rate of 30%~34%. AZA with or without all-trans retinoic acid (ATRA) can cooperatively inhibit leukemia cell proliferation , induce apoptosis and differentiation.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (2017 edition)，excludes acute promyelocytic leukemia (M3、APL) and myelodysplastic syndromes(2017 edition)
• Be at least 18 years of age on day of signing informed consent
• Not suitable for newly diagnosed patients with intensive chemotherapy
• Not suitable for newly diagnosed patients with receiving hematopoietic stem cell transplantation
• The proportion of blast cells was below 50% in bone marrow
• Total white blood cell (WBC) count ≤10,000/µL；Must be able to swallow tablets

Exclusion criteria

• Malignant neoplasms with other progression
• Serious mental illness uncooperative
• Refusal to join the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Azacytidine Combined With ARTA

Experimental group

Description:

Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle with ATRA 20mg tid by po on days 1-21 of every cycle 28 days

Treatment:

Drug: Azacitidine

Drug: all trans retinoic acid

Azacytidine

Experimental group

Description:

Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle

Treatment:

Drug: Azacitidine