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Blinatumomab for Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Led By Jonathan Webster, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Pre-B ALL patients in CR1 with high-risk features or all Pre-B ALL patients in second and higher CR

ECOG performance status 0-2

Must not have

History of severe acute GVHD or active severe chronic GVHD

Weight <45 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is looking at whether a drug called blinatumomab is safe to use in patients who have had a stem cell transplant to treat leukemia or non-Hodgkin's lymphoma.

Who is the study for?

Adults over 18 with B-cell malignancies like ALL or NHL, post-allogeneic HSCT. They must be in remission but at high risk of relapse, within a specific time frame from transplant, and have recovered blood counts without disease progression. Fertility requires contraception use during the study. Exclusions include recent chemo/radiotherapy, uncontrolled illnesses, certain medications for GVHD, poor organ function, pregnancy/lactation, infections like HIV/HBV/HCV, severe GVHD history or active CNS/testes disease.

What is being tested?

The trial is testing blinatumomab's safety as a maintenance therapy after allogeneic HSCT in patients with CD19+ B-cell cancers (ALL and NHL). It aims to prevent cancer recurrence by using different doses of blinatumomab along with dexamethasone to manage potential side effects.

What are the potential side effects?

Blinatumomab may cause flu-like symptoms such as fever and chills; neurological issues including headaches and confusion; allergic reactions; low blood cell counts leading to increased infection risk; fatigue; nausea; and liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

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

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I have high-risk Pre-B ALL in my first complete remission or am in my second or later complete remission.

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I can take care of myself and perform daily activities.

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I have NHL and had a transplant that didn't fully replace my bone marrow.

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I am 18 years old or older.

Exclusion Criteria

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

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I have had severe acute or active severe chronic graft-versus-host disease.

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I weigh less than 45 kg.

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I am currently being treated for another cancer.

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I have a significant brain or nervous system condition.

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I have HIV or chronic hepatitis B or C.

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My organs are not functioning properly.

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My bone marrow transplant from a donor did not work.

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My condition worsened after a transplant.

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I have Ph-positive ALL and cannot receive TKI maintenance after a transplant.

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I do not have any ongoing serious infections or illnesses.

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I have active or untreated disease in my brain or testes.

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I am on maintenance therapy after a transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Overall survival at two years post first treatment cycle

Secondary study objectives

Disease-free Survival

Minimal Residual Disease

Non-Relapse Mortality

+2 more

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%

Abdominal pain

13%

Platelet count decreased

13%

Rash

13%

Hypertension

11%

Erythema

11%

Pruritus

11%

Hypokalaemia

11%

Hypogammaglobulinaemia

11%

Hypotension

Neutropenia

Epistaxis

Tremor

Constipation

Neutrophil count decreased

White blood cell count decreased

Alanine aminotransferase increased

Immunodeficiency

Agitation

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

Complication associated with device

Nervous system disorder

Klebsiella infection

Perineal cellulitis

Accidental overdose

Haematoma

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

1Treatment groups

Experimental Treatment

Group I: Post-alloHSCT MaintenanceExperimental Treatment4 Interventions

Blinatumomab will be administered as a continuous intravenous (IV) infusion over four weeks followed by a two-week treatment free interval. It is recommended that patients are hospitalized at least during the first three days of the first cycle and the first two days of the second cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blinatumomab

2014

Completed Phase 3

~1230

Dexamethasone

2007

Completed Phase 4

~2650