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Monoclonal Antibodies

Blinatumomab + TKI for Acute Lymphoblastic Leukemia

Q: To what extent does dexamethasone help patients?

dexamethasone is a medication with many applications, some of which include the treatment of synovitis, ophthalmia, and sympathetic. Additionally, dexamethasone can be used to manage branch retinal vein occlusion and <a href="https://www.withpower.com/clinical-trials/sclc">sclc</a>.

Q: What is the projected size of this research project?

That is correct, the clinicaltrials.gov website does list this study as currently open for recruitment. The listing was first created on March 30th 2020 and most recently updated on June 28th 2022. At present, there are 3 active recruiting sites looking for a total of 17 participants.

Q: Are there long-term repercussions to prescription dexamethasone?

There is some clinical data suggesting that dexamethasone is safe, but none affirming its efficacy.

Q: Are investigators actively looking for participants in this trial?

Yes, the information available on clinicaltrials.gov specifies that this study is currently looking for participants. The trial was originally posted on March 30th 2020 and has been updated as recently as June 28th 2022. At the moment, the team running the trial are hoping to recruit 17 patients from 3 different locations.

Phase 2

Waitlist Available

Led By Mark Geyer, 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

ECOG performance status 0-2

Age ≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether adding the drug blinatumomab to standard treatment for Ph+ ALL can improve responses.

Who is the study for?

Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who haven't had treatment beyond corticosteroids or certain chemotherapies. Participants must be able to consent, have acceptable liver function and organ health, agree to use birth control during and after the study, and have a performance status indicating they are relatively active.Check my eligibility

What is being tested?

The trial is testing blinatumomab combined with tyrosine kinase inhibitor therapy (like dasatinib) against standard care for Ph+ ALL. The goal is to see if adding blinatumomab improves outcomes compared to just corticosteroids plus TKI therapy.See study design

What are the potential side effects?

Potential side effects include allergic reactions, liver enzyme changes, nerve damage symptoms like tingling or numbness, fatigue, headache, fever, bleeding complications and increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and perform daily activities.

Select...

I am 18 years old or older.

Select...

I have been diagnosed with ALL and it's confirmed to be Philadelphia chromosome positive.

Select...

I have only had steroids, hydroxyurea, or preventive brain/spinal cord chemo for my ALL.

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

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

Primary outcome measures

Proportion of evaluable patients achieving complete molecular response

Secondary outcome measures

Cumulative incidence of morphologic and molecular relapse following consolidative therapy with blinatumomab in combination with an oral TKI

Duration of CMR among patients achieving MRD negativity after TKI + corticosteroid induction, followed by 1-3 cycles of blinatumomab in combination with an oral TKI.

Event-free survival following consolidative therapy with blinatumomab in combination with an oral TKI.

+4 more

Other outcome measures

Frequency, type, and co-occurrence of ABL kinase mutations

Frequency, type, and co-occurrence of new somatic mutations

Side effects data

From 2015 Phase 3 trial • 393 Patients • NCT00004228

98%

Leukocytes (total WBC)

98%

Hemoglobin (Hgb)

98%

Platelets

97%

Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia

97%

SGOT (AST)

97%

SGPT (ALT)

97%

Febrile neutropenia

95%

Catheter-related infection

95%

Infection/Febrile Neutropenia

93%

Infection without neutropenia

93%

Osteonecrosis (avascular necrosis)

93%

Renal failure

93%

Serum Creatinine

93%

Bilirubin

92%

Pancreatitis

92%

Seizure(s)

92%

CNS cerebrovascular ischemia

92%

Cardiac left ventricular function

92%

Cardiovascular/Arrhythmia

66%

Neutrophils/granulocytes (ANC/AGC)

41%

Transfusion: pRBCs

30%

Transfusion: Platelets

21%

Hyperglycemia

18%

Hypokalemia

16%

Lymphopenia

16%

Hypocalcemia

15%

Headache

13%

Vomiting

11%

Abdominal pain or cramping

11%

Dermatology/Skin

11%

Stomatitis/pharyngitis (oral/pharyngeal mucositis)

11%

Diarrhea (without colostomy)

11%

Neuropathy - motor

11%

Hypoalbuminemia

11%

Hyponatremia

10%

Hypertension

10%

Pleural effusion (non-malignant)

Pneumonitis/pulmonary infiltrates

Nausea

Fever

Neuropathic pain

Anorexia

Pain

Constipation

Rash/desquamation

Hypotension

Thrombosis/embolism

Hypermagnesemia

Hypophosphatemia

Fibrinogen

Fatigue (lethargy, malaise, asthenia)

Dehydration

Hypercalcemia

Weight loss

Hypoxia

Metabolic/Laboratory

Bone pain

GGT

Partial thromboplastin time (PTT)

Hypernatremia

Allergic Rhinitis

Blood/Bone Marrow

Cushingoid appearance

Neuropathy - sensory

Amylase

Alkaline phosphatase

DIC (disseminated intravascular coagulation)

Sinus tachycardia

Pruritus

Renal/Genitourinary

Hyperkalemia

Allergy/Immunology

Typhlitis (inflammation of cecum)

Pericardial effusion/pericarditis

Lipase

Adult respiratory distress syndrome (ARDS)

Mood alteration-depression

Hypomagnesemia

Musculoskeletal

Ataxia (incoordination)

Dizziness/lightheadedness

Cough

Dyspnea (shortness of breath)

Chest pain (non-cardiac and non-pleuritic)

Hypoglycemia

Hyperuricemia

Myalgia (muscle pain)

Speech impairment

Allergic reaction/hypersensitivity

Gastritis

Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)

Seizure

Hypercholesterolemia

Weight gain

Pneumothorax

Wound-non infectious

Leukoencephalopathy associated radiological findings

Hepatic

infection

Cardiovascular/General

Hematemesis

Mood alteration-anxiety, agitation

Neurology

Rectal bleeding/hematochezia

Melena/GI bleeding

Proctitis

Esophagitis

Fever, Increase BP, Back pain

difficulty with speech, Left sided numbness

Middle ear/hearing

Prothrombin time (PT)

Coagulation

Constitutional Symptoms

Alopecia

SIADH (syndrome of inappropriate antidiuretic hormone)

Gastric ulcer

CNS hemorrhage/bleeding

Infection with unknown ANC

Neuropathy - cranial

Acidosis (metabolic or respiratory)

Bicarbonate

Endocrine

Fistula-intestinal

Ileus

Hematuria (in the absence of vaginal bleeding)

Tremor

Pulmonary

Lt Hemiplegia

Hypertriglyceridemia

Personality/behavioral

Vertigo

100%

80%

60%

40%

20%

Study treatment Arm

A2 (Disseminated, No CNS - CCG Mod BFM w/Intens

A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens

B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens

B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens

B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment

B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy

A0 (Localized Disease Stg I/II) Modified CCG BFM

Trial Design

1Treatment groups

Experimental Treatment

Group I: Blinatumomab & Concurrent Oral Tyrosine Kinase Inhibitor (TKI)Experimental Treatment4 Interventions

Patients may receive steroids and hydroxyurea pre-study entry and receive a 7-day steroid prephase before starting TKI therapy. Planned initial TKI is dasatinib 140 mg daily; dasatinib dose may be reduced or TKI may be changed to a different agent under certain conditions. Induction consists of continuous TKI + 24 days of dexamethasone, followed by taper of dexamethasone, with bone marrow aspirate/biopsy (BMA) and CNS prophylaxis at days 22 and 43. Patients achieving morphologic complete response post-induction proceed to consolidation with up to 3 cycles of blinatumomab (28-day cycles, 14 days between cycles) + TKI, with BMA and CNS prophylaxis between cycles. Patients achieving complete molecular response may proceed to maintenance with up to 4 more cycles of blinatumomab (28-day cycles with 28 days between cycles) + TKI, with CNS prophylaxis between cycles and BMA after cycles 5 and 7. Patients can come off study to undergo allogeneic hematopoietic cell transplantation at any time.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blinatumomab

2014

Completed Phase 3

~1210

dasatinib

2011

Completed Phase 3

~2000

dexamethasone

1995

Completed Phase 3

~9860

methotrexate

1997

Completed Phase 3

~9960

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor

1,370 Previous Clinical Trials

1,377,671 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,605 Total Patients Enrolled

Mark Geyer, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

23 Total Patients Enrolled

Media Library

Blinatumomab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04329325 — Phase 2

Acute Lymphoblastic Leukemia Research Study Groups: Blinatumomab & Concurrent Oral Tyrosine Kinase Inhibitor (TKI)

Acute Lymphoblastic Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT04329325 — Phase 2

Blinatumomab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04329325 — Phase 2

Frequently Asked Questions

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

To what extent does dexamethasone help patients?

"dexamethasone is a medication with many applications, some of which include the treatment of synovitis, ophthalmia, and sympathetic. Additionally, dexamethasone can be used to manage branch retinal vein occlusion and sclc."

Answered by AI

What is the projected size of this research project?

"That is correct, the clinicaltrials.gov website does list this study as currently open for recruitment. The listing was first created on March 30th 2020 and most recently updated on June 28th 2022. At present, there are 3 active recruiting sites looking for a total of 17 participants."

Answered by AI

Are there long-term repercussions to prescription dexamethasone?

"There is some clinical data suggesting that dexamethasone is safe, but none affirming its efficacy."

Answered by AI

Are investigators actively looking for participants in this trial?

"Yes, the information available on clinicaltrials.gov specifies that this study is currently looking for participants. The trial was originally posted on March 30th 2020 and has been updated as recently as June 28th 2022. At the moment, the team running the trial are hoping to recruit 17 patients from 3 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

2020. "Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04329325.

All > All > Dasatinib