← Back to Search

Alkylating agents

Chemotherapy Combination for Leukemia

Phase 2

Recruiting

Led By Gautam Borthakur

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have untreated AML, or high-risk myelodysplastic syndromes (MDS) characterized by specific cytogenetic abnormalities

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. The drugs work in different ways to stop the growth of cancer cells.

Who is the study for?

This trial is for adults with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. It's open to those with certain organ dysfunctions, who may receive adjusted doses. Participants must be able to consent and use effective contraception. Those with up to one prior treatment cycle are included if initial good-risk cytogenetics were missed.Check my eligibility

What is being tested?

The study tests a combination of chemotherapy drugs (fludarabine phosphate, cytarabine, idarubicin hydrochloride) and a targeted therapy (gemtuzumab ozogamicin), plus filgrastim-sndz to boost the immune system after chemo. The goal is to see how well these treatments work together in killing cancer cells or stopping their growth.See study design

What are the potential side effects?

Potential side effects include damage to organs where dose adjustments might be needed, increased risk of infection due to immune system impact from chemotherapy, allergic reactions from monoclonal antibodies like gemtuzumab ozogamicin, and general chemo side effects such as nausea, fatigue, hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have untreated AML or high-risk MDS with certain genetic features.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete remission rate

Toxicity rate

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)Experimental Treatment7 Interventions

See Detailed Description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

FDA approved

Idarubicin

FDA approved

Filgrastim

FDA approved

Gemtuzumab ozogamicin

FDA approved

Cytarabine

FDA approved

Decitabine

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,977 Previous Clinical Trials

1,789,278 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,692 Previous Clinical Trials

40,929,440 Total Patients Enrolled

Gautam BorthakurPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

163 Total Patients Enrolled

Media Library

Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT00801489 — Phase 2

Cytarabine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00801489 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently recruiting volunteers?

"Per the information available on clinicaltrials.gov, this investigation is actively searching for participants. This research trial was originally advertised on April 4th 2007 and recently updated on July 26th 2022."

Answered by AI

Are there analogous investigations into the properties of Fludarabine Phosphate?

"At present, there are 764 trials researching Fludarabine Phosphate with 106 of them in the late-stage phase 3. Grand Rapids, Michigan is where a majority of these studies have been run; however, 16092 clinical sites across the world are running investigations into this medication's efficacy."

Answered by AI

How many participants have enrolled for this medical experiment?

"Affirmative. Clinicaltrials.gov data suggests that this clinical trial is open for enrollment and needs 200 people to join at 1 location, as it was first posted on April 4th 2007 and last updated July 26th 2022."

Answered by AI

To what ailment is Fludarabine Phosphate usually prescribed?

"Fludarabine Phosphate can be beneficially applied to the treatment of meningeal leukemia, mobilization of hematopoietic stem cells therapy, and acute myelocytic leukemia."

Answered by AI

Is Fludarabine Phosphate deemed medically safe for use by patients?

"We at Power assigned Fludarabine Phosphate a score of 2 on the safety scale as it is currently in Phase 2 trials. This implies that there are some data regarding its safety but not with regards to efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

2007. "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. https://clinicaltrials.gov/ct2/show/NCT00801489.

All > Acute Myeloid Leukemia > Flu