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Anti-metabolites

Combination Chemotherapy for Relapsed or Refractory Leukemia

Phase 1
Waitlist Available
Led By Tapan M Kadia
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
For cohort A of the expansion phase: Patients with a diagnosis untreated adverse-risk AML (as defined by ELN [European Leukemia Net Classification] 2017) will be enrolled
For cohort B of the expansion phase: Patients with a diagnosis of relapsed or refractory AML will be enrolled
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 weeks
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat leukemia. The drugs work in different ways to stop the growth of cancer cells. The combination of these drugs may work better than current treatment.

Who is the study for?
This trial is for patients with various types of leukemia that have relapsed or are not responding to treatment. Eligible participants must understand the study, sign consent, have certain normal organ function tests, and a performance status indicating they can care for themselves. Pregnant or breastfeeding women cannot join, nor can those with uncontrolled illnesses or allergies to chemotherapy components.Check my eligibility
What is being tested?
The trial is testing pegcrisantaspase combined with fludarabine and cytarabine in treating relapsed/refractory leukemia. It aims to find the best dose of pegcrisantaspase and see if this combination works better than just fludarabine and cytarabine alone.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to the drugs, blood chemistry changes (like altered enzyme levels), digestive issues (nausea/vomiting), fatigue, increased risk of infection due to low blood cell counts, bleeding complications from low platelets, and liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have untreated high-risk AML according to the ELN 2017 guidelines.
Select...
I have relapsed or refractory AML.
Select...
I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Disease
Duration of response
ORR of fludarabine, cytarabine (araC), and pegcrisantaspase
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pegcrisantaspase, fludarabine, cytarabine)Experimental Treatment3 Interventions
INDUCTION: Patients receive pegcrisantaspase IV over 60 minutes on days 1 and 15, and fludarabine IV over 15-30 minutes and cytarabine IV over 2 hours on days 8-11 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive pegcrisantaspase IV over 60 minutes on days 1 and 15, and fludarabine IV over 15-30 minutes and cytarabine IV over 2 hours on days 8-10. Treatment repeats every 5 weeks for up 3 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cytarabine
2016
Completed Phase 3
~3310

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,197 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,470 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,154 Total Patients Enrolled

Media Library

Cytarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04526795 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Treatment (pegcrisantaspase, fludarabine, cytarabine)
Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT04526795 — Phase 1
Cytarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04526795 — Phase 1

Frequently Asked Questions

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

What have been the outcomes of prior research involving Pegcrisantaspase?

"As of now, 573 clinical trials are being conducted for Pegcrisantaspase with 72 of those studies occupying the Phase 3 stage. Although Saint Louis is the epicentre for this research, 12773 different sites around the world have been approved to run tests on this medication."

Answered by AI

What is the enrollment capacity of this trial?

"Affirmative. Evidence hosted on clinicaltrials.gov demonstrates that this medical research, which was posted April 9th 2021, is actively searching for participants. 62 patients need to be recruited from a sole centre of operation."

Answered by AI

What are the eligibility criteria for participating in this research trial?

"This clinical trial is recruiting 62 participants who have been diagnosed with either AML, ALL, T-cell prolymphocytic leukemia, biphenotypic acute leukemia or the blast phase of CML and are aged between 18 and 65. To qualify for cohort B of the expansion stage, applicants must demonstrate a relapsed or refractory form of AML as well as an Eastern Cooperative Oncology Group (ECOG) performance status that does not exceed 2."

Answered by AI

Is this trial open to individuals who have not yet reached the age of 45?

"According to the requirements, individuals aged 18 and 65 are eligible for this clinical trial. Additionally, there are 818 studies available for minors and 2482 trials suitable for seniors."

Answered by AI

Could you explain the level of security associated with Pegcrisantaspase treatments?

"The safety rating of Pegcrisantaspase is 1, as this Phase 1 trial has limited data confirming its efficacy and safety."

Answered by AI

Are participants currently being sought for this examination?

"The evidence supplied on clinicaltrials.gov attests that this research project is actively recruiting patients, first posted in April 2021 and last updated July 2022."

Answered by AI

How is Pegcrisantaspase employed therapeutically?

"Pegcrisantaspase is a commonly prescribed treatment for leptomeningeal metastases and has been used to address acute promyelocytic leukemia, meningeal leukemia, and blast phase chronic myelocytic leukemia."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fludarabine, Cytarabine, and Pegcrisantaspase for the Treament of Relapsed or Refractory Leukemia
2021. "Fludarabine, Cytarabine, and Pegcrisantaspase for the Treament of Relapsed or Refractory Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04526795.
~3 spots leftby Dec 2024
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