← Back to Search

Anti-metabolites

Pediatric-Inspired Chemotherapy for Leukemia

Phase 2

Waitlist Available

Led By Jae Park, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Previously untreated Ph negative precursor B-cell or T-cell ALL confirmed by conventional flow cytometry or immunohistochemical stain

Age 18 - 60 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing whether a chemotherapy regimen used to treat children with acute lymphoblastic leukemia (ALL) is also safe and effective for adults with Ph-negative ALL.

Who is the study for?

Adults aged 18-60 with newly diagnosed Ph Negative Acute Lymphoblastic Leukemia (ALL) who haven't been treated yet. They must have good kidney, liver, and heart function, an ECOG performance status of 0-2, and be willing to use birth control. People with certain other conditions or previous ALL treatments are excluded.Check my eligibility

What is being tested?

The trial is testing a 'Pediatric-Inspired' chemotherapy regimen in adults with ALL to see if it's safe and effective. It includes drugs like Daunorubicin and Vincristine among others used in children's treatment protocols for leukemia.See study design

What are the potential side effects?

Possible side effects include nausea, vomiting, hair loss, increased risk of infection due to low blood cell counts (myelosuppression), liver toxicity, allergic reactions to the drugs being tested, fatigue, mouth sores from Methotrexate and potential nerve damage from Vincristine.

Eligibility Criteria

Inclusion Criteria

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

Select...

My leukemia is a type that has not been treated and does not have the Ph chromosome.

Select...

I am between 18 and 60 years old.

Select...

My kidney function is good, with creatinine levels or clearance within the required range.

Select...

My heart pumps well, with an ejection fraction of 50% or higher.

Select...

I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

rate of molecular remission

Secondary outcome measures

complete remission (CR)

disease free survival (DFS) rates

event-free survival (EFS)

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Leukemia PatientsExperimental Treatment12 Interventions

The treatment plan has 6 treatment cycles. The cycle names are listed in the following order: Induction Phase I - Induction Phase II - Intensification I - Re-induction I - Intensification II - Re-induction II Each cycle is given over a period of 4-6 weeks and the interval between them can range between 1-3 weeks. Based the patients medical condition, the doctor may decide to change the timing of the drugs, the interval between the drugs in a cycle, or the interval between the cycles. After receiving all cycles you will continue with a 36 months treatment part that is called Maintenance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daunorubicin

FDA approved

Vincristine

FDA approved

Prednisone

FDA approved

Pegaspargase

FDA approved

Methotrexate

FDA approved

Cyclophosphamide

FDA approved

Cytarabine

FDA approved

Leucovorin

FDA approved

Dexamethasone

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,816 Total Patients Enrolled

116 Trials studying Leukemia

9,303 Patients Enrolled for Leukemia

ShireIndustry Sponsor

456 Previous Clinical Trials

97,253 Total Patients Enrolled

3 Trials studying Leukemia

1,849 Patients Enrolled for Leukemia

Duke UniversityOTHER

2,363 Previous Clinical Trials

3,420,470 Total Patients Enrolled

15 Trials studying Leukemia

1,377 Patients Enrolled for Leukemia

Frequently Asked Questions

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

In what scenarios is Cytarabine typically recommended?

"Cytarabine can be used to fight pheochromocytomas, in addition to other conditions such as eye lesions, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Are there any openings currently available for this trial's participants?

"This clinical trial, which initially launched on August 1st 2013 and was last updated November 7th 2022, is no longer actively enrolling participants. However, there are currently 3470 other studies that remain open to new patients."

Answered by AI

Are individuals aged below twenty years old eligible for this trial?

"This clinical trial is seeking participants aged between 18 to 60 years old. There are 906 trials aimed at patients under the age of majority and 2826 studies for those over senior status."

Answered by AI

Has Cytarabine been examined in other research studies?

"Initially researched in 1997 at City of Hope Comprehensive Cancer Center, cytarabine has since been subject to 3668 completed medical trials. In the present day, approximately 1975 live studies are being conducted with a considerable portion taking place within New york, NY."

Answered by AI

What criteria must be met to qualify for this clinical experiment?

"Candidates aged between 18 and 60, who have been diagnosed with leukemia, are eligible to join this trial. Currently, 39 patients need to be enrolled in the study."

Answered by AI

Is Cytarabine a reliable option for those seeking relief?

"After evaluating the data available, our team at Power concluded that Cytarabine's safety level is a 2. This is because Phase 2 trials have demonstrated its safety but not necessarily its efficacy."

Answered by AI

How many volunteers are engaged with this clinical experimentation?

"No longer accepting patient enrolment, this study was initially posted on August 1st 2013 and last updated November 7th 2022. As an alternative, 1495 trials are actively recruiting participants with leukemia while 1975 clinical studies are currently taking in patients being treated for Cytarabine."

Answered by AI

Recent research and studies

HaematologicaJournal

Pediatric-inspired Chemotherapy Incorporating Pegaspargase Is Safe and Results in High Rates of Minimal Residual Disease Negativity in Adults up to Age 60 with Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia

Geyer, Mark B., Ellen K. Ritchie, Arati V. Rao, Shreya Vemuri, Jessica Flynn, Meier Hsu, Sean M. Devlin, et al.. 2020. “Pediatric-inspired Chemotherapy Incorporating Pegaspargase Is Safe and Results in High Rates of Minimal Residual Disease Negativity in Adults up to Age 60 with Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia”. Haematologica. Ferrata Storti Foundation (Haematologica). doi:10.3324/haematol.2020.251686.

clinicaltrials.govStudy

A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia

2013. "A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01920737.

All > Leukemia > All