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Status unknownNCT04505995Updated Aug 10, 2020

Azacitidine and Homoharringtonine in JMML

An interventional study of Azacitidine and homoharringtonine in JMML, sponsored by Air Force Military Medical University, China. Status unknown at 1 site in China. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2020-08-10.

Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2020, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
1 Month to 18 Years
Sex
All
01

Study summary

Juvenile myelomonocytic leukemia (JMML) has a poor prognosis in general, with hematopoietic stem cell transplant (HSCT) remaining the standard of care for cure. Azacitidine and homoharringtonine, which exhibited a anticancer mechanism and has been widely used in patients with relapse/refractory acute myeloid leukemia (AML). However, the efficacy of these agents has not been elucidated in children with JMML. The primary objective is to assess the treatment effect on response rate in this subject population.

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Conditions studied

  • JMML
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In context

Lead sponsor

Air Force Military Medical University, China is the lead sponsor of 172 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Newly diagnosed JMML, with PB and BM confirming diagnosis prior to informed consent signature, with one of the following:

    1. somatic mutation in PTPN11
    2. somatic mutation in KRAS
    3. somatic mutation in NRAS and HbF % > 5x normal value for age
    4. clinical diagnosis of neurofibromatosis Type 1.

Exclusion criteria

Exclusion Criteria:

    1. Any condition that would prevent the subject from participating in the study.

      1. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if participated in the study.
      1. Any condition that confounds the ability to interpret data from the study.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Drug: Azacitidine and homoharringtonine

Interventions

  • DrugAzacitidine and homoharringtonine

    Concommitant use of azacitidine and homoharringtonine

06

What researchers measure

Primary outcomes

  1. Juvenile Myelomonocytic Leukemia (JMML) response rate at end of 4 Months

    Defined as proportion of patients with sustained clinical complete remission \[cCR\] or clinical partial remission \[cPR\] according to the International JMML response criteria in Niemeyer 2014 at 3 months (28 days cycles). Response must be sustained for at least 4 weeks either in the 4-week period preceding or succeeding 3 months (ie, sustained over the period minimum 2 months to end of 3 months, or end of 3 months to end of 4 months).

    Time frame: Up to 4 Months

07

Study locations

1 of 1 sites recruiting
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
    Tianjin, Tianjin 300020, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04505995
Lead sponsor
Air Force Military Medical University, China
Collaborators
Qilu Hospital of Shandong University, Taian City Central Hospital, The Affiliated Hospital of Qingdao University, The Second Hospital of Hebei Medical University, Children's Hospital of Hebei Province
Responsible party
Lipeng Liu (Dr, Air Force Military Medical University, China) — Principal investigator
First posted
Aug 10, 2020
Start date
Jan 1, 2020
Primary completion
Jan 1, 2023 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
Aug 10, 2020

Study contacts

Wen-Yu Yang, M.D.
Contact
yangwenyu@ihcams.ac.cn
+86-22-23909138

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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