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CAR T-cell Therapy

CAR-T Therapy for Acute Lymphoblastic Leukemia

Tampa, FL

Phase 2

Recruiting

Led By Bijal D. Shah, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Pathologically confirmed CD19 positive B-cell acute lymphoblastic leukemia

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if CAR-T therapy is safe and effective in treating B-ALL patients in remission with minimal disease.

See full description

Who is the study for?

Adults over 18 with B-cell acute lymphoblastic leukemia (B-ALL) that's CD19 positive can join. They must be in remission but still have minimal residual disease after induction chemotherapy. Participants need to be generally healthy, able to follow the trial schedule, and willing to use birth control during and for 6 months after the study.Check my eligibility

What is being tested?

The trial is testing KTE-X19 CAR T-cell therapy's effectiveness and safety in treating B-ALL patients who are in remission but have some remaining cancer cells detectable at very low levels.See study design

What are the potential side effects?

KTE-X19 may cause immune system reactions, fever, fatigue, headache, breathing difficulties, changes in blood pressure or heart rate. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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My leukemia is CD19 positive.

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I am fully active or can carry out light work.

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My blood cell counts are within a healthy range.

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My cancer is in complete remission with very few cancer cells left after initial treatment.

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My cancer has fully responded to treatment, including in the brain or spinal cord.

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I am 18 years old or older.

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I am a woman who can have children and I have a negative pregnancy test.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse Free Survival (RFS)

Secondary study objectives

Clinical Relapse Rate

Duration of Response (DOR)

Molecular Relapse Free Survival (MRFS)

+5 more

Side effects data

From 2023 Phase 2 trial • 105 Patients • NCT02601313

100%

Anaemia

100%

Platelet count decreased

100%

CYTOKINE RELEASE SYNDROME

90%

Pyrexia

80%

Neutrophil count decreased

80%

White blood cell count decreased

70%

Chills

70%

Fatigue

70%

Headache

60%

Hyponatraemia

60%

Hypokalaemia

50%

Diarrhoea

50%

Weight decreased

50%

Hypoalbuminaemia

50%

Confusional state

50%

Dyspnoea

40%

Encephalopathy

40%

Nausea

40%

Sinus tachycardia

40%

Hypocalcaemia

40%

Decreased appetite

40%

Hypophosphataemia

40%

Anxiety

40%

Hypoxia

30%

Dry mouth

30%

Asthenia

30%

Atrial fibrillation

30%

Lymphocyte count decreased

30%

Aspartate aminotransferase increased

30%

Alanine aminotransferase increased

30%

Memory impairment

30%

Muscular weakness

30%

Myalgia

30%

Tremor

30%

Cough

30%

Dizziness

30%

Insomnia

30%

Pleural effusion

30%

Hypertension

20%

Oral pain

20%

Hypotension

20%

Stomatitis

20%

Constipation

20%

Abdominal pain

20%

Abdominal distension

20%

Vomiting

20%

Lethargy

20%

Upper respiratory tract infection

20%

Hyperglycaemia

20%

Back pain

20%

Aphasia

20%

Bone pain

20%

Paraesthesia

20%

Rash maculo-papular

20%

Papilloedema

20%

Herpes zoster

20%

Amnesia

10%

Corynebacterium infection

10%

Fall

10%

Pneumonia

10%

Dysphagia

10%

Flatulence

10%

Gastrooesophageal reflux disease

10%

Mediastinal haemorrhage

10%

Bone marrow failure

10%

Bradycardia

10%

Nocardiosis

10%

Oedema peripheral

10%

Vision blurred

10%

Generalised oedema

10%

Non-cardiac chest pain

10%

Malaise

10%

Oedema

10%

Paraesthesia oral

10%

Gait disturbance

10%

Hypogammaglobulinaemia

10%

Sinusitis

10%

Urinary tract infection

10%

Hypomagnesaemia

10%

Dehydration

10%

Blood alkaline phosphatase increased

10%

Blood creatinine increased

10%

Neuropathy peripheral

10%

Hyperkalaemia

10%

Arthralgia

10%

Restless legs syndrome

10%

Agitation

10%

Dysarthria

10%

Cognitive disorder

10%

Somnolence

10%

Neck pain

10%

Acute kidney injury

10%

Irritability

10%

Alopecia

10%

Dysuria

10%

Urinary retention

10%

Seizure

10%

Hypoaesthesia

10%

Oropharyngeal pain

10%

Oral infection

10%

Orthostatic hypotension

10%

Skin Infection (BILATERAL HANDS, IMPETIGO)

10%

Conjunctival hyperaemia

10%

Acute sinusitis

10%

Congestion

10%

Past-pointing

10%

Toothache

10%

Deafness

10%

Hypoacusis

10%

Otitis externa

10%

Blood fibrinogen decreased

10%

Neuralgia

10%

Hemiparesis

10%

Psychotic disorder

10%

Productive cough

10%

Wheezing

10%

Partial seizures

10%

Tooth infection

10%

Muscle atrophy

10%

Renal failure

10%

Neurological decompensation

10%

Slow speech

10%

Respiratory alkalosis

10%

Onychomadesis

10%

Rash pruritic

10%

Dyskinesia

100%

80%

60%

40%

20%

Study treatment Arm

2 x 10^6 Axicabtagene Ciloleucel

Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel

Retreatment Cohort 1

Retreatment Cohort 2

Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Autologous CAR T-cell immunotherapyExperimental Treatment1 Intervention

Tecartus will be delivered at a target dose of 1x106 cells / kg. For those \>100 kg, a flat dose of 1 x108 cells will be used. Tecartus will be administered on day 0, following 1 day of rest from conditioning chemotherapy.

0 / 7Eligibility criteria met