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Chemotherapy

Isatuximab for Acute Lymphoblastic Leukemia (ISAKIDS Trial)

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 28 days to less than 18 years of age, at the time of signing the informed consent.
Participants must have a confirmed diagnosis of relapsed Acute Lymphoblastic Leukemia (ALL) of T- or B-cell origin including T-lymphoblastic lymphoma (LBL), or relapsed Acute Myeloblastic Leukemia (AML) including participants with history of myelodysplasia.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until the study completion date, approximately 46 months
Awards & highlights

ISAKIDS Trial Summary

This trial is testing the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML).

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia

ISAKIDS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must be between 4 weeks and 17 years old when you agree to participate.
Select...
You have been diagnosed with relapsed Acute Lymphoblastic Leukemia (ALL) of T- or B-cell origin or relapsed Acute Myeloblastic Leukemia (AML) including participants with history of myelodysplasia.
Select...
You have been treated for your disease before, but it has come back or is not responding to your most recent treatment. Even if you have had prior relapses, you may still be eligible.
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You have had only one previous attempt at treatment for your condition.
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Your white blood cell count is less than 20 x109/L on the first day of the trial before receiving isatuximab.

ISAKIDS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening until the study completion date, approximately 46 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until the study completion date, approximately 46 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Complete Response (CR) Rate
Secondary outcome measures
AML: AUC of Isatuximab
AML: Ceoi of Isatuximab
AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
+12 more

Side effects data

From 2023 Phase 3 trial • 307 Patients • NCT02990338
35%
Neutropenia
21%
Fatigue
21%
Pneumonia
21%
Diarrhoea
20%
Constipation
19%
Upper Respiratory Tract Infection
19%
Asthenia
16%
Back Pain
13%
Pyrexia
12%
Oedema Peripheral
12%
Arthralgia
11%
Thrombocytopenia
11%
Bronchitis
11%
Muscle Spasms
9%
Dyspnoea
9%
Urinary Tract Infection
9%
Insomnia
9%
Nausea
9%
Bone Pain
7%
Nasopharyngitis
7%
Peripheral Sensory Neuropathy
7%
Cough
7%
Cataract
7%
Pruritus
6%
Headache
6%
Fall
5%
Disease Progression
5%
Hypertension
5%
Decreased Appetite
5%
Tremor
5%
Rash
5%
Muscular Weakness
5%
Musculoskeletal Chest Pain
4%
Influenza
4%
Abdominal Pain
4%
Acute Kidney Injury
4%
Vomiting
3%
Pneumocystis Jirovecii Pneumonia
3%
Febrile Neutropenia
3%
Oropharyngeal Pain
3%
Septic Shock
3%
Pathological Fracture
3%
Dizziness
3%
Stomatitis
3%
Myalgia
3%
Pain In Extremity
2%
Hypercalcaemia
2%
Oral Herpes
2%
Productive Cough
2%
General Physical Health Deterioration
2%
Renal Failure
2%
Lung Infection
2%
Lower Respiratory Tract Infection
1%
Haemorrhage Intracranial
1%
Syncope
1%
Cardiac Failure
1%
Atrial Fibrillation
1%
Cerebral Haemorrhage
1%
Cauda Equina Syndrome
1%
Diverticulitis
1%
Escherichia Sepsis
1%
Gastroenteritis
1%
Respiratory Tract Infection
1%
Anaemia
1%
Dehydration
1%
Ischaemic Stroke
1%
Orthostatic Hypotension
1%
Pleural Effusion
1%
Pulmonary Embolism
1%
Pulmonary Oedema
1%
Respiratory Failure
1%
Pancreatitis Acute
1%
Death
1%
Accidental Overdose
1%
Diabetic Ulcer
1%
Pneumonia Bacterial
1%
Pneumonia Fungal
1%
Pyelonephritis
1%
Pyelonephritis Acute
1%
Sepsis
1%
Sinusitis
1%
Hyperviscosity Syndrome
1%
Pancytopenia
1%
Malnutrition
1%
Sudden Death
1%
Femur Fracture
1%
Infusion Related Reaction
1%
Spinal Compression Fracture
1%
Cytomegalovirus Gastrointestinal Infection
1%
Pneumonia Haemophilus
1%
Pneumonia Influenzal
1%
Pneumonia Streptococcal
1%
Basal Cell Carcinoma
1%
Tumour Associated Fever
1%
Hyponatraemia
1%
Confusional State
1%
Bronchospasm
1%
Large Intestine Perforation
1%
Renal Aneurysm
1%
Weight Decreased
1%
Covid-19
1%
Covid-19 Pneumonia
1%
Candida Pneumonia
1%
Infection
1%
Presyncope
1%
Spinal Subdural Haematoma
1%
Retinal Detachment
1%
Vision Blurred
1%
Angina Pectoris
1%
Myocardial Infarction
1%
Deep Vein Thrombosis
1%
Ataxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pd (Pomalidomide + Dexamethasone)
IPd (Isatuximab + Pomalidomide + Dexamethasone)

ISAKIDS Trial Design

1Treatment groups
Experimental Treatment
Group I: Acute Myeloid Leukemia (AML) and Acute Lymphoblastic LeukemiaExperimental Treatment18 Interventions
This arm includes participants from 3 cohorts: AML, T-ALL and B-ALL.; AML: Weekly dosing of isatuximab with induction chemotherapy. The therapy may be repeated one more cycle; ALL: (Includes T-ALL and B-ALL) Weekly dosing of isatuximab with induction chemotherapy, then biweekly dosing of isatuximab with consolidation chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Idarubicin
2014
Completed Phase 4
~4330
Doxorubicin
2012
Completed Phase 3
~7940
Fludarabine
2012
Completed Phase 3
~1090
Etoposide
2010
Completed Phase 3
~2440
Hydroxyurea
2006
Completed Phase 4
~3620
Cytarabine
2016
Completed Phase 3
~3310
Cyclophosphamide
1995
Completed Phase 3
~3780
Mitoxantrone
2008
Completed Phase 3
~1510
Vincristine
2003
Completed Phase 4
~2920
Methotrexate
2013
Completed Phase 4
~3800
Isatuximab
2016
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,158 Previous Clinical Trials
3,514,281 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,888 Total Patients Enrolled

Frequently Asked Questions

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

Has Isatuximab received government sanctioning for therapeutic use?

"Isatuximab's safety is based on some data from Phase 2 trials, so it received a score of 2."

Answered by AI

Are patients that are beyond a certain age able to partake in this research?

"According to the age requirements for this clinical trial, eligible participants must be 28 days old or younger and no older than 17."

Answered by AI

What are some of the common illnesses that Isatuximab has been known to effectively treat?

"Isatuximab is frequently used to manage macular edema but can also be given as treatment for other conditions such ulcerative colitis, pheochromocytomas, and certain eye conditions."

Answered by AI

Are there any current vacancies in this clinical trial for new patients?

"Yes, as of today this clinical trial is still recruiting patients. The latest update on the study was posted on November 15th, 2022 and it was first made available to the public on August 6th, 2019."

Answered by AI

If I qualify, may I participate in this research project?

"This study is looking for 96 participants that have a history of acute lymphoblastic leukemia (ALL), are aged 28 days to 17 years, and have relapsed or are refractory to most recent treatment. Other important requirements include being in first or second relapse and having a white blood cell count below 20 x109/L on Day 1 before isatuximab administration."

Answered by AI

At how many locations is this experiment being conducted?

"There are a total of 14 enrolling patients for this clinical trial, which includes locations such as Investigational Site Number 8400004 in Cincinnati, Seattle Childrens Hospital and Regional Medical Center-Site Number:8400003 in Seattle, and Cincinnati Children's Hospital Medical Center-Site Number:8400004 in Dallas."

Answered by AI

What are some other papers which mention Isatuximab specifically?

"Isatuximab was first explored in 1997 by Spectrum Health Hospital - Butterworth Campus. With 4074 trials completed, it is one of the most widely studied drugs. At the moment, 2100 clinical trials are underway with a large majority hosted out of Cincinnati, Ohio."

Answered by AI

Is this research novel in any way?

"More than two thousand ongoing studies involving isatuximab are being conducted in nearly one hundred countries and three thousand cities. The first study, sponsored by Alfacell Corporation, was completed in 1997 with 300 patients. It reached Phase 3 approval that year. In the 24 years since then, 4,074 total studies have been concluded."

Answered by AI

How many research participants will this study be able to accommodate?

"In order to proceed, the study sponsor (Sanofi) needs a total of 96 eligible patients. These subjects will be recruited from multiple clinical sites; for example, 8400004 in Cincinnati, Ohio and 8400003 at Seattle Childrens Hospital."

Answered by AI
~12 spots leftby Mar 2025