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Chemotherapy + Lestaurtinib for Acute Lymphoblastic Leukemia

Q: Has the Federal Drug Administration cleared Cyclophosphamide for public use?

Cyclophosphamide's safety has been well-documented in past Phase 3 trials, so it received a score of 3.

Q: To what end does a medical professional usually prescribe Cyclophosphamide?

Cyclophosphamide is effective in treating synovitis, as well as other issues such as proctitis, scalp structure, and <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a>.

Q: Is there precedent for using Cyclophosphamide in similar treatment plans?

Cyclophosphamide is being trialled in 549 phase 3 clinical trials, 2355 of which are currently ongoing. The drug is being tested at 80376 different locations, with a notable concentration of research taking place in Changsha, Hunan.

Q: Are we still looking for participants for this experiment?

Unfortunately, this study is no longer looking for patients that fit the specified criteria. It was initially posted on 1/14/2008 and updated for the last time on 8/17/2022. However, there are still many other trials searching for <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, lymphocytic, acute, l1 participants (1550 clinical trials) and 2355 Cyclophosphamide trials actively recruiting patients.

Q: What is the total number of participants in this research project?

Unfortunately, this trial is not currently enrolling new patients. The study was posted on 1/14/2008 and updated for the last time on 8/17/2022. However, there are many other studies that may be of interest; 1550 trials concerning <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, lymphocytic, acute, l1 and 2355 involving Cyclophosphamide are presently recruiting.

Q: How many different sites are currently running this research project?

Mission Hospital Inc-Memorial Campus in Asheville, <a href="https://www.withpower.com/clinical-trials/north-carolina">North carolina</a>, Floating Hospital for Children at Tufts Medical Center in Boston, <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a>, and Children's Hospital and Research Center at Oakland in Oakland, <a href="https://www.withpower.com/clinical-trials/california">California</a> are some of the locations where this study is enrolling patients. 100 other sites are also participating.

Phase 3

Waitlist Available

Led By Joanne Hilden

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

Patients must be < 366 days of age at the time of diagnosis; for neonates in the first month of life, patients must be > 36 weeks gestational age at the time of diagnosis

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of post-induction therapy for up to 10 years

Awards & highlights

Study Summary

This trial tests a new cancer drug with chemotherapy to see if it's more effective than chemotherapy alone in treating young patients with a certain type of leukemia.

Who is the study for?

This trial is for young patients with newly diagnosed acute lymphoblastic leukemia or undifferentiated leukemia. Eligible participants must be under 1 year old, untreated except for steroids and intrathecal chemo, and enrolled in a COG classification study. Those with mature B-cell ALL, AML, or Down syndrome cannot join.Check my eligibility

What is being tested?

The trial is testing how well combination chemotherapy works with or without lestaurtinib in treating young patients. Chemotherapy aims to stop cancer cell growth by various means; lestaurtinib blocks enzymes needed for cell growth. It's unknown if adding lestaurtinib improves outcomes.See study design

What are the potential side effects?

Chemotherapy can cause side effects like nausea, hair loss, fatigue, increased risk of infection due to low blood counts, and potential damage to organs over time. Lestaurtinib may add risks such as liver issues and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

My child was diagnosed before turning 1 year old and was born after 36 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of post-induction therapy for up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of post-induction therapy for up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of post-induction therapy for up to 10 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

Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)

Secondary outcome measures

Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

+10 more

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401

88%

Pyrexia

65%

Neutrophil count decreased

62%

Nausea

58%

Hypotension

50%

Anaemia

46%

Headache

38%

Decreased appetite

38%

Fatigue

35%

Confusional state

31%

Hypokalaemia

31%

Diarrhoea

31%

Tachycardia

27%

Constipation

27%

Back pain

27%

Hypophosphataemia

23%

Dizziness

23%

Platelet count decreased

23%

Tremor

23%

B-cell lymphoma

23%

White blood cell count decreased

19%

Oedema peripheral

19%

Neutropenia

19%

Cough

19%

Hypogammaglobulinaemia

19%

Hyponatraemia

19%

Tachypnoea

19%

Agitation

15%

Alanine aminotransferase increased

15%

Thrombocytopenia

15%

Chills

15%

Dyspnoea

15%

Hypomagnesaemia

15%

Sinus tachycardia

15%

Dysphagia

12%

Hypertension

12%

Vomiting

12%

Abdominal pain

12%

Aspartate aminotransferase increased

12%

Pain

12%

Malaise

12%

Myalgia

12%

Hypoxia

12%

Arthralgia

12%

Hyperglycaemia

12%

Covid-19

12%

Peripheral sensory neuropathy

Hyperhidrosis

Aphasia

Pancytopenia

Muscular weakness

Pneumonia

Encephalopathy

Eye pain

Gait disturbance

Oral candidiasis

Urinary tract infection

Sepsis

Blood creatinine increased

Acute myeloid leukaemia

Insomnia

Somnolence

Dysuria

Asthenia

Lymphocyte count decreased

Pleural effusion

Covid-19 pneumonia

Respiratory failure

Febrile neutropenia

Embolism

Depression

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Axicabtagene Ciloleucel and Rituximab Combination

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C (IR/HR MLL-R chemotherapy and lestaurtinib)Experimental Treatment22 Interventions

Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age >= 90 days at diagnosis and High Risk (HR) if age < 90 days at diagnosis.

Group II: Arm A (standard risk MLL-G)Experimental Treatment21 Interventions

Population Description: Eligible patients with MLL-G (germline, or non-rearranged)

Group III: Arm B (IR/HR MLL-R chemotherapy)Active Control21 Interventions

Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age >= 90 days at diagnosis and High Risk (HR) if age < 90 days at diagnosis.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3310

Etoposide

2010

Completed Phase 3

~2440

Pegaspargase

2005

Completed Phase 3

~9010

Daunorubicin Hydrochloride

2011

Completed Phase 3

~5070

Mercaptopurine

2012

Completed Phase 4

~12330

Methylprednisolone

2015

Completed Phase 4

~2280

Leucovorin Calcium

2011

Completed Phase 3

~12290

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Dexamethasone

2007

Completed Phase 4

~2590

Vincristine Sulfate

2005

Completed Phase 3

~10110

Echocardiography

2013

Completed Phase 4

~11670

Biospecimen Collection

2004

Completed Phase 2

~1730

Filgrastim

2000

Completed Phase 3

~3670

Asparaginase

2005

Completed Phase 4

~5000

Cyclophosphamide

1995

Completed Phase 3

~3780

Methotrexate

2013

Completed Phase 4

~3800

Prednisone

2014

Completed Phase 4

~2370

Therapeutic Hydrocortisone

2012

Completed Phase 3

~340

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

237,482 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,935 Total Patients Enrolled

Joanne HildenPrincipal InvestigatorChildren's Oncology Group

Frequently Asked Questions

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

Has the Federal Drug Administration cleared Cyclophosphamide for public use?

"Cyclophosphamide's safety has been well-documented in past Phase 3 trials, so it received a score of 3."

Answered by AI

To what end does a medical professional usually prescribe Cyclophosphamide?

"Cyclophosphamide is effective in treating synovitis, as well as other issues such as proctitis, scalp structure, and prostate cancer."

Answered by AI

Is there precedent for using Cyclophosphamide in similar treatment plans?

"Cyclophosphamide is being trialled in 549 phase 3 clinical trials, 2355 of which are currently ongoing. The drug is being tested at 80376 different locations, with a notable concentration of research taking place in Changsha, Hunan."

Answered by AI

Are we still looking for participants for this experiment?

"Unfortunately, this study is no longer looking for patients that fit the specified criteria. It was initially posted on 1/14/2008 and updated for the last time on 8/17/2022. However, there are still many other trials searching for leukemia, lymphocytic, acute, l1 participants (1550 clinical trials) and 2355 Cyclophosphamide trials actively recruiting patients."

Answered by AI

What is the total number of participants in this research project?

"Unfortunately, this trial is not currently enrolling new patients. The study was posted on 1/14/2008 and updated for the last time on 8/17/2022. However, there are many other studies that may be of interest; 1550 trials concerning leukemia, lymphocytic, acute, l1 and 2355 involving Cyclophosphamide are presently recruiting."

Answered by AI

How many different sites are currently running this research project?

"Mission Hospital Inc-Memorial Campus in Asheville, North carolina, Floating Hospital for Children at Tufts Medical Center in Boston, Massachusetts, and Children's Hospital and Research Center at Oakland in Oakland, California are some of the locations where this study is enrolling patients. 100 other sites are also participating."

Answered by AI

Recent research and studies

HaematologicaJournal

Combinatorial Efficacy of Entospletinib and Chemotherapy in Patient-derived Xenograft Models of Infant Acute Lymphoblastic Leukemia

Joseph P. Loftus, Anella Yahiaoui, Patrick A. Brown, Lisa M. Niswander, Asen Bagashev, Min Wang, Allyson Schauf, Stacey Tannheimer, and Sarah K. Tasian. 2020. “Combinatorial Efficacy of Entospletinib and Chemotherapy in Patient-derived Xenograft Models of Infant Acute Lymphoblastic Leukemia”. Haematologica. Ferrata Storti Foundation (Haematologica). doi:10.3324/haematol.2019.241729.

clinicaltrials.govStudy

Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

2008. "Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00557193.

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