NCT00398047

Combination of Azacitadine and Hematopoietic Growth Factors for Myelodysplastic Syndrome

Terminated Phase 2 Results posted Last updated 7 August 2018

What this trial tests

Phase 2 trial testing Azacitadine and Hematopoietic Growth Factors in Leukemia in 3 participants. Terminated before completion.

Timeline

1 September 2006

Primary endpoint
1 September 2009

1 September 2009

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	1 September 2006
Primary completion	1 September 2009
Estimated completion	1 September 2009
Sites	1 location across United States

Drugs / interventions tested

• Azacitadine and Hematopoietic Growth Factors — full drug profile →

Conditions studied

• Leukemia — all drugs for Leukemia →
• Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

Wake Forest University Health Sciences

Who can join

Under 120, any sex, with Leukemia or Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With Complete Response
  Time frame: Approximately 112 days
  Complete response is normalization of abnormal blood counts, and disappearance of signs of morphological changes in the bone marrow. If the previously present cytogenetic abnormalities are absent then it is referred also as a cytogenetic complete remission.
• Rate of Major Hematological Improvement
  Time frame: Approximately 112 days
  For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for red cell transfusion-dependent patients, transfusion independence.

Sponsor's own description

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as darbepoetin alfa and G-CSF, may increase the number of red blood cells and white blood cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving azacitidine together with darbepoetin alfa and G-CSF may be an effective treatment for myelodysplastic syndromes.

PURPOSE: This clinical trial is studying how well giving azacitidine together with darbepoetin alfa and G-CSF works in treating patients with myelodysplastic syndromes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Trials with 'epigenetic' drugs: an update.
   Nebbioso A, Carafa V, Benedetti R, Altucci L. · · 2012 · cited 162× · PMID 23103179 · DOI 10.1016/j.molonc.2012.09.004