Clinical trial for Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Official title Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
ClinicalTrials.gov ID: NCT00801489
What this study is testing
What is Cytarabine?
Cytarabine is an investigational chemotherapy drug being studied for acute myeloid leukemia with the inv(16)(p13.1q22) genetic abnormality. Cytarabine is designed to interfere with DNA synthesis by incorporating into DNA and inhibiting DNA polymerase, which stops cancer cells from dividing.
Also referred to as Ara-C, Cytosar, Cytosine arabinoside, Aracytidine, Arabinosylcytosine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks how well a combination of five medicines works and looks for side effects.
- Who it's for
- Adults with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome.
- What's involved
- Participants receive chemotherapy drugs and a targeted therapy, plus a shot to help blood counts recover.
- Time commitment
- The source text does not specify the total duration or number of visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have untreated AML, or high-risk myelodysplastic syndromes (MDS) (refractory anemia with excess blasts, [RAEB], or RAEB "in...
- Patients must provide written consent
- Participants will not be excluded based on performance status; for patients with Eastern Cooperative Oncology Group (ECOG) performance status \>= to...
- Patients with organ dysfunction will not be excluded from the study
- Up to one cycle of prior induction therapy will be permitted to include patients in whom presence of "good-risk" cytogenetics was initially missed
You likely can't join if
- Pregnant and lactating females will be excluded
See the full eligibility criteria
- Patients must have untreated AML, or high-risk myelodysplastic syndromes (MDS) (refractory anemia with excess blasts, [RAEB], or RAEB "in transformation" [RAEB-t]) characterized by t(8;21), inv(16), or t(16;16)
- Patients must provide written consent
- Participants will not be excluded based on performance status; for patients with Eastern Cooperative Oncology Group (ECOG) performance status \>= to 3 the dosing schedule will be discussed with study chairman
- Patients with organ dysfunction will not be excluded from the study; for patients with evidence of organ dysfunction (creatinine \>= 1.5, cardiac ejection fraction =\ =2 and aspartate aminotransferase [AST]/alanine...
- Up to one cycle of prior induction therapy will be permitted to include patients in whom presence of "good-risk" cytogenetics was initially missed
- Patients of child bearing potential should practice effective methods of contraception
- Pregnant and lactating females will be excluded
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.