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Cell Therapy

Blinatumomab + HCT for Acute Lymphoblastic Leukemia

Phase 2

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age

First remission with persistent disease identified as end of consolidation (EOC) MRD > 0.01%.

Must not have

Active malignancy other than B-ALL.

Pregnant or lactating. The agents used in this study are known to be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 7 days prior to registration to rule out pregnancy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days +19, +91, +135 and +180 post-hct

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing whether a new treatment for leukemia, which uses cells from another person, followed by a different drug, can help reduce relapse rates and improve survival.

Who is the study for?

This trial is for young people (≤25 years) with high-risk B-cell acute lymphoblastic leukemia. They must be in remission or have very-high risk biology ALL and an available donor for a stem cell transplant. Participants need good organ function, controlled seizures if present, no active infections or GVHD, and agree to use contraception.

What is being tested?

The study tests alpha/beta T-cell and B-cell depleted hematopoietic cell transplantation followed by blinatumomab therapy to see if it can lower relapse rates and improve survival in patients with high-risk B-ALL while reducing treatment side effects.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to the treatments, which could affect various organs. Specific side effects are not listed but would relate to the interventions used: HCT procedure and blinatumomab therapy.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may not be able to do active work or play.

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My cancer is in its first remission but still shows minimal signs of disease.

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My B-ALL is in remission with no detectable disease in my bone marrow.

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I have not had brain or spinal radiation during this study, and it's been over 90 days since my last radiation if I ever had any.

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I am 25 years old or younger.

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I am in remission after my first or later relapse.

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My ALL is high-risk and I'm going for a stem cell transplant in my first remission.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active cancer that is not B-cell Acute Lymphoblastic Leukemia.

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I am not pregnant or breastfeeding and have taken a pregnancy test within the last 7 days.

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My cancer has spread outside the bone marrow.

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I am allergic to certain cancer drugs.

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I am not receiving any cancer treatments not listed in the study protocol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days +19, +91, +135 and +180 post-hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days +19, +91, +135 and +180 post-hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and days +19, +91, +135 and +180 post-hct for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of patients who are able to receive the blinatumomab infusion [Feasibility]

Secondary study objectives

Acute & Chronic GVHD

Cumulative incidence of treatment-related adverse events [Tolerability]

Disease Free Survival

+9 more

Other study objectives

Analysis of immune cell phenotyping

Functional assessment of lymphocyte subsets

Serum cytokine analysis

Side effects data

From 2022 Phase 3 trial • 111 Patients • NCT02393859

80%

Pyrexia

43%

Nausea

37%

Headache

31%

Vomiting

24%

Anaemia

22%

Diarrhoea

20%

Stomatitis

17%

Mucosal inflammation

13%

Rash

13%

Abdominal pain

13%

Platelet count decreased

13%

Hypertension

11%

Erythema

11%

Pruritus

11%

Hypokalaemia

11%

Hypogammaglobulinaemia

11%

Hypotension

Tremor

Neutropenia

Epistaxis

Constipation

Neutrophil count decreased

White blood cell count decreased

Alanine aminotransferase increased

Agitation

Immunodeficiency

Hypervolaemia

Anal inflammation

Cough

Thrombocytopenia

Abdominal pain upper

Petechiae

Fluid overload

Back pain

Rash maculo-papular

Paronychia

Decreased appetite

Fatigue

Nasopharyngitis

Febrile neutropenia

Urticaria

Fluid balance positive

Seizure

Oropharyngeal pain

Aplasia

Pain in extremity

Neurological symptom

Aspartate aminotransferase increased

Oral pain

Engraftment syndrome

Herpes virus infection

Blood immunoglobulin G decreased

Haematoma

Complication associated with device

Nervous system disorder

Klebsiella infection

Perineal cellulitis

Accidental overdose

Neurological examination abnormal

Catheter placement

Antithrombin III decreased

Laryngotracheitis obstructive

Pain

Hypertransaminasaemia

Rhinitis

Body temperature increased

100%

80%

60%

40%

20%

Study treatment Arm

Blinatumomab

HC3 Chemotherapy

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Alpha/beta T-cell and B-cell Depleted, Reduced Intensity HCTExperimental Treatment2 Interventions

Patients who are MRD Negative by Flow cytometry and are MRD Negative by High Throughput Sequencing, will receive a reduced intensity conditioning regimen followed by an alpha/beta T-cell and B-cell depleted transplant. They will also receive a 28 day continuous infusion of blinatumomab starting on Day 100 post-transplant in the absence of significant ongoing GVHD.

Group II: Alpha/beta T-cell and B-cell Depleted, Myeloablative HCTExperimental Treatment2 Interventions

Patients who are MRD Negative by Flow cytometry but are MRD Positive by High Throughput Sequencing, will receive a myeloablative conditioning regimen which includes total body irradiation (TBI) followed by an alpha/beta T-cell and B-cell depleted transplant. They will also receive a 28 day continuous infusion of blinatumomab starting on Day 100 post-transplant in the absence of significant ongoing GVHD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blinatumomab

FDA approved

0 / 12Eligibility criteria met