Phase 2
Completed N=39
Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant
leukemia · Childhood Myelodysplastic Syndromes · Chronic myelomonocytic leukemia · Previously Treated Myelodysplastic Syndromes
Source: ClinicalTrials.gov NCT01083706 ↗
Enrolled (actual)
39
Serious AEs
7.7%
Results posted
May 2017
Primary outcomePrimary: Overall Survival — 25 Participants
Summary
This phase II trial studies how well azacitidine works in treating patients with relapsed myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) who have undergone stem cell transplant. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
25 | — |
| SECONDARY Rate of Response by IWG Criteria |
12 | — |
| SECONDARY Incidence of Grades II-IV Graft-versus-host Disease (GVHD) |
25 | — |
Eligibility Criteria
Inclusion Criteria
- MDS, CMML or AML patients (as diagnosed by World Health Organization [WHO] criteria) with evidence of relapse or progression at >= day 28 and = day 28 and = 10% bone marrow myeloblasts as measured by morphology
- Evidence of central nervous system (CNS) disease at time of relapse by morphology or flow (a diagnostic lumbar puncture [LP] is not required at time of relapse)
- Serum creatinine > 2 x ULN (upper limit of normal)
- Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 2x ULN
- Performance status > 2 (Eastern Cooperative Oncology Group [ECOG] Scale)
- Patients with severe disease other than MDS, CMML or AML which would be expected to prevent compliance with treatment
- Patients with severe infections (pneumonia, sepsis, etc) within the 2 weeks prior to the anticipated start of protocol treatment
Data sourced from ClinicalTrials.gov (NCT01083706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.