← Back to Search

Alkylating agents

A arm (DA-90) for Acute Myeloid Leukemia (PALG-AML1/2016 Trial)

Phase 3
Waitlist Available
Led By Sebastian Giebel, Prof.
Research Sponsored by Polish Adult Leukemia Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of acute myeloid leukemia (≥20% of blasts in the bone marrow)
Previously untreated AML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on +7 day after chemotherpay
Awards & highlights

PALG-AML1/2016 Trial Summary

This trial will study two different induction chemotherapy regimens for newly diagnosed AML patients to see which is more effective. Bone marrow aspiration with MRD will be performed on day seven after induction to evaluate response to treatment. Patients who do not achieve complete remission (CR) after two induction courses will be randomized to one of two standard salvage regimens.

Eligible Conditions
  • Acute Myeloid Leukemia

PALG-AML1/2016 Trial Eligibility Criteria

Inclusion Criteria

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

PALG-AML1/2016 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on +7 day after chemotherpay
This trial's timeline: 3 weeks for screening, Varies for treatment, and on +7 day after chemotherpay for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Induced Hyperthermia
Induction regimen efficacy (DA-90 vs DAC) - II induction
Salvage regimen efficacy (CLAG-M vs FLAG-IDA) - I reinduction
+1 more

PALG-AML1/2016 Trial Design

4Treatment groups
Active Control
Group I: A arm (DA-90)Active Control1 Intervention
Induction I: DNR 90 mg/m2 D 1-3 in 30-60 min i.v. infusion Ara-C 100 mg/m2 D 1-7 in 24 h i.v. infusion
Group II: B arm (DAC)Active Control1 Intervention
Induction I: DNR 60 mg/m2 D 1-3 in 30-60 min i.v. infusion cladribine 5 mg/m2 D 1-5 in 2 h i.v. infusion prior to Ara-C Ara-C 200 mg/m2 D 1-7 in 22 h i.v. infusion.
Group III: A arm (CLAG-M)Active Control1 Intervention
Cladribine 5mg/m2 in 2 h i.v. infusion on days (1-5) Ara-C 2 g/m2 in 4 h i.v. infusion, 2 h after cladribine infusion on days (1-5) Mitoxantrone 10 mg/m2 i.v. 1xd on days (1-3) G-CSF 30MU s.c. 1xd from day 0 to 5 of the treatment (6 doses).
Group IV: B arm (FLAG-IDA)Active Control1 Intervention
Fludarabine 30 mg/m2 in 30-min i.v. infusion on days (1-5) Ara-C 2 g/m2 in 4 h i.v. infusion, 2 h after fludarabine infusion on days (1-5). Idarubicin 8 mg/m2 i.v. 1xd on days (1-3) G-CSF 30MU s.c. 1xd from day 0 to 5 of the treatment (6 doses).

Find a Location

Who is running the clinical trial?

Polish Adult Leukemia GroupLead Sponsor
4 Previous Clinical Trials
1,179 Total Patients Enrolled
Sebastian Giebel, Prof.Principal InvestigatorPolish Adult Leukemia Group
3 Previous Clinical Trials
217 Total Patients Enrolled

Frequently Asked Questions

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

Is this study enrolling new participants at this time?

"According to the clinicaltrials.gov website, this study is still looking for volunteers. The trial was originally posted on July 3rd, 2017 and the listing was last updated on September 30th, 2021."

Answered by AI

Has the FDA cleared arm A (DA-90) for use?

"There is both efficacy and safety data from prior clinical trials to support A arm (DA-90), which is why it was given a safety score of 3."

Answered by AI

Will this study consider patients who are middle-aged or older?

"This clinical trial only allows patients aged 18 to 60 to enroll. Out of the 2,132 trials on this website, only 452 are for people under the age of 18 and 1,280 are for patients over the age of 65."

Answered by AI

What is the most common reason why doctors prescribe arm A (DA-90)?

"The most popular treatment for myeloblastic leukemia is A arm (DA-90). A arm (DA-90) is also able to help patients with neoplasms, leptomeningeal metastases, and chronic lymphocytic leukemia (cll)."

Answered by AI

Which patients does this research project seek to enroll?

"This medical trial is looking for 582 individuals between the ages of 18 and 60 who have leukemia, myeloid, acute. In addition to meeting these general requirements, patients must also meet the following specific criteria: Be previously untreated for AML, have AML de novo, have AML secondary to myelodysplastic syndromes (MDS), be of age ≥ 18 years and ≤60 years while signing a written consent form, have a general state according to the ECOG ≤ 2 scale (Annex 1), have an index of comorbidities, have HCT-CI ≤ 3, according to"

Answered by AI

Are there similar trials that have used DA-90 before?

"There are 752 clinical trials currently underway that involve the A arm (DA-90). Of these, 108 are in Phase 3. The A arm (DA-90) trials are being conducted in Saint Louis, Missouri, but there are a total of 18268 locations where these trials are taking place."

Answered by AI
~76 spots leftby Mar 2025