Combination Chemotherapy Followed By Donor Bone Marrow or Umbilical Cord Blood Transplant in Treating Children With Newly Diagnosed Juvenile Myelomonocytic Leukemia
Completed · Phase 2
Conditions studied: Juvenile Myelomonocytic Leukemia
In brief
Giving chemotherapy drugs, such as R115777, isotretinoin, cytarabine, and fludarabine, before a donor bone marrow transplant or an umbilical cord transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. This phase II trial is studying how well giving combination chemotherapy together with donor bone marrow or umbilical cord blood transplant works in treating children with newly diagnosed juvenile myelomonocytic leukemia
Key facts
- Study ID
- NCT00025038
- Run by
- National Cancer Institute (NCI)
- People needed
- 100
- Starts
- 2001-06-01
- Last updated by the study team
- 2013-04-11
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Newly diagnosed, previously untreated juvenile myelomonocytic leukemia
- Presenting with all of the following:
- Absence of t(9;22) or bcr/abl by PCR
- Absolute monocyte count greater than 1,000/mm\^3
- Less than 20% bone marrow blasts
- Presenting with at least 2 of the following:
- Elevated F hemoglobin
- Myeloid precursors in peripheral blood
- WBC greater than 10,000/mm\^3
- Sargramostim (GM-CSF) hypersensitivity
- See Disease Characteristics
- Bilirubin no greater than 2.0 mg/dL
- ALT no greater than 3 times normal
- Creatinine no greater than 2 times normal
- No concurrent sargramostim (GM-CSF)
- No concurrent proton pump inhibitors
Where it is running
- Children's Oncology Group — Arcadia, California, United States
Full record on ClinicalTrials.gov
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