3-AP and Fludarabine in Treating Patients With Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia, or Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia
| Status: | Archived |
|---|---|
| Conditions: | Blood Cancer, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
Phase II Trial of Triapine (IND # 68338, NSC #663249, 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbone) Plus Fludarabine (NSC #312887, Fludarabine Monophosphate) in Adults With Aggressive Myeloproliferative Disorders (MPDs) Including Chronic Myelomonocytic Leukemia (CMML) and Chronic Myelogenous Leukemia in Accelerated Phase (CML-AP) or Blast Crisis (CML-BC)
RATIONALE: Drugs used in chemotherapy, such as 3-AP and fludarabine, work in different ways
to stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. 3-AP may help fludarabine work better by making cancer cells more sensitive to the
drug. 3-AP and fludarabine may also stop the growth of cancer cells by blocking some of the
enzymes needed for cell growth. Giving 3-AP together with fludarabine may kill more cancer
cells.
PURPOSE: This phase II trial is studying how well giving 3-AP together with fludarabine
works in treating patients with myeloproliferative disorders (MPD), chronic myelomonocytic
leukemia (CMML), or accelerated phase or blastic phase chronic myelogenous leukemia.
OBJECTIVES:
- Determine the efficacy of 3-AP (Triapine®) followed by fludarabine phosphate in
patients with myeloproliferative disorders or chronic myelomonocytic leukemia in
aggressive phase or transformation or chronic myelogenous leukemia in accelerated phase
or blast crisis.
- Determine the toxicity of this regimen in these patients.
- Determine, preliminarily, the effect of this regimen on circulating leukemic cell
genetics in these patients.
OUTLINE: This is an open-label study.
Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over
30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.
Patients undergo bone marrow and/or peripheral blood collection at baseline and periodically
during study treatment for molecular analysis of Janus kinase 2 (JAK2) mutations, GATA-1
mutations, and expression of the death-inducer-obliterator (Dido) genes on chromosome 20q.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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