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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 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Gemtuzumab ozogamicin
FDA approved
Decitabine
FDA approved
Filgrastim
FDA approved
Fludarabine
FDA approved
Idarubicin
FDA approved
Cytarabine
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,376 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,768 Total Patients Enrolled
Gautam BorthakurPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
163 Total Patients Enrolled

Media Library

Myelodysplastic Syndrome 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
~29 spots leftby Dec 2026
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