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CAR T-cell Therapy
Modified T-Cell Therapy for Acute Lymphoblastic Leukemia
Phase 1
Waitlist Available
Led By Kevin Curran, 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
CNS-3 leukemia at diagnosis
t(17;19) ALL or Ph-Like ALL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing if it's safe to give leukemia patients their own modified blood cells. The goal is to find a safe dose.
Who is the study for?
This trial is for pediatric and young adult patients with a relapse of B-cell acute lymphoblastic leukemia. Eligible participants include those diagnosed at age ≥13 years, with specific genetic markers or high-risk features, and who are in their first or subsequent bone marrow relapse.Check my eligibility
What is being tested?
The study tests the safety of modified T-cells made from the patient's own blood to treat leukemia that has returned. It aims to determine a safe dose for these special cells after standard chemotherapy regimens.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever, fatigue, drop in blood pressure, difficulty breathing, and organ inflammation. Chemotherapy can cause nausea, hair loss, mouth sores, and increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia was CNS-3 at diagnosis.
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My leukemia is either t(17;19) ALL or Ph-Like ALL.
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I was diagnosed with high-risk acute lymphoblastic leukemia at 13 or older.
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My cancer cells have fewer than 44 chromosomes or a low DNA index.
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My cancer has an MLL gene rearrangement.
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My leukemia is Philadelphia chromosome positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
safety
Secondary outcome measures
assess the persistence of modified T cells
the development of B cell aplasia
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2 (Morphologic Disease)Experimental Treatment3 Interventions
Pts with morphologic evidence of disease at the time of T cell infusion, (≥5% blasts in the bone marrow) as assessed by morphology or flow cytometry. Participating site PI to determine cohort stratification in the event of morphology/flow cytometry blast count discrepancy. Pts with increased blasts (5-10% blasts) that are immunophenotypically consistent with recovering marrow from prior re-induction chemo may be treated under Cohort 1 with approval of the participating site PI. Cohort 2 pts will get conditioning chemo followed by 1x10^6 19-28z+ T cells/kg over 1 to 2 days. During formulation of EOP T cells, under or over estimation of CAR modified T-cells may occur. Pts may get up to 35% over total cell dose with approval by the participating site PI. Both cohorts, pts will be allowed to receive a 2nd treatment of 19-28z+ T cells if they benefited from the first infusion & did not experience any non-hematologic grade 4 toxicities.
Group II: Cohort 1 (MRD)Experimental Treatment3 Interventions
Patients with no morphologic evidence of disease at the time of T cell infusion, (<5% blasts in the bone marrow) as assessed by morphology or flow cytometry. Participating site PI to determine cohort stratification in the event of morphology/flow cytometry blast count discrepancy. Cohort 1 patients will receive conditioning chemotherapy followed by 1x10^6 19-28z+ T cells/kg over 1 to 2 days. During formulation of End of Production (EOP) T cells, under or over estimation of CAR modified T-cells may occur. Patients may receive an altered fractionation of the total doses (e.g. ½ on Day 0 and ½ on Day +1) or up to 35% over total cell dose with approval by the participating site PI. In both cohorts, patients will be allowed to receive a 2nd treatment of 19-28z+ T cells if they benefited from the first infusion and did not experience any non-hematologic grade 4 toxicities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
modified T cells
2011
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,787 Total Patients Enrolled
Dana-Farber Cancer Institute:Dana- Farber/Children's HospitalUNKNOWN
Kevin Curran, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
111 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia was CNS-3 at diagnosis.There is still evidence of cancer cells in your bone marrow after the initial treatment.My leukemia is either t(17;19) ALL or Ph-Like ALL.I was diagnosed with high-risk acute lymphoblastic leukemia at 13 or older.My cancer has an MLL gene rearrangement.My cancer cells have fewer than 44 chromosomes or a low DNA index.The initial treatment did not work, and you still have leukemia in your bone marrow at a specific time point.My leukemia is Philadelphia chromosome positive.My leukemia has returned after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 (Morphologic Disease)
- Group 2: Cohort 1 (MRD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any past experiments that have involved altered T cells?
"Currently, 816 clinical trials are being conducted to assess the efficacy of modified T cells; 154 of which have advanced to Phase 3. Philadelphia, Pennsylvania is a primary locale for this research yet there are over twenty-seven thousand medical centres around the world running trial studies concerning these treatments."
Answered by AI
Is the trial availabe to participants at this juncture?
"According to the clinicaltrials.gov platform, this trial has ceased recruitment; it was initially posted on May 1st 2013 and last updated January 26th 2022. Nevertheless, there are 2312 other medical studies currently seeking participants."
Answered by AI
Has the FDA granted clearance for modified T cells to be used in treatment?
"Due to limited data supporting the efficacy and safety of modified T cells, this trial was given a score of 1."
Answered by AI
What have modified T cells typically been utilized to ameliorate?
"Autologous modified T cells are widely used to treat multiple sclerosis and can also be administered to combat mixed-cell type lymphoma, leukemia, myelocytic acute, and retinoblastoma."
Answered by AI
Are there any limitations on the number of participants being enrolled in this research?
"This trial is no longer enrolling. Initially posted on May 1st 2013, and most recently edited January 26th 2022, this study has reached its patient capacity. If you are seeking alternate studies to participate in, there are currently 1496 trials for leukemia that require participants as well as 816 investigations related to modified T cells looking for volunteers."
Answered by AI
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