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Bone Marrow Transplant

Azacitidine +/- Gemtuzumab for Post-Transplant Relapse for MDS, CMML and AML (FHCRC-2240)
Treatment of Post-Transplant Relapse and Persistent Disease in Patients with MDS, CMML and AML with Azacitidine +/- Gemtuzumab
Status Conditions Phase Study ID
Recruiting Adult Acute Myeloid Leukemia (AML)
Childhood Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Phase II FHCRC-2240
NCT01083706
Summary

RATIONALE: 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. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving azacitidine together with gemtuzumab ozogamicin works in treating patients relapsed myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid leukemia who have undergone stem cell transplant.


Investigator
Bart Scott, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • MDS, CMML or AML patients (as diagnosed by WHO criteria) with evidence of relapse or progression at >= day 28 and < day 100 post-transplant
  • Recurrent or increased cytogenetic abnormalities by standard karyotype or FISH (the cytogenetic abnormalities must have been previously documented at some time point between diagnosis and date of stem cell transplant)
  • Morphologic evidence of recurrence or increased abnormal myeloblasts in peripheral blood or marrow
  • Flow Cytometric evidence of disease as determined by recurrent or increased abnormal myeloblasts in peripheral blood or marrow
  • Extramedullary relapse (local radiotherapy will be allowed)
  • MDS, CMML, or AML patients with persistent stable disease or persistent disease with regression at >= day 28 and < day 100 post-transplant
  • Persistence of cytogenetic abnormalities by standard karyotype or FISH
  • Persistent morphologic evidence of abnormal myeloblasts (in patients with CMML the monoblastoid population is included) in peripheral blood or marrow
  • Persistent flow cytometric evidence of abnormal myeloblasts (in patients with CMML the monoblastoid population is included) in peripheral blood or marrow
  • Extramedullary persistence or regression
Last Updated
October 25, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.