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Monoclonal Antibodies

Inotuzumab + Chemotherapy for Leukemia (ALL-001 Trial)

Phase 1
Waitlist Available
Led By Michael Douvas, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function, including serum creatinine ≤ 1.6 mg/dL OR creatinine clearance >50 ml/min by Cockgroft-Gault formula, bilirubin ≤ 1.5 mg/dL (except in patients with Gilbert's disease), AST, ALT and alkaline phosphatase ≤ 3 x upper limit of normal (elevation exceeding this threshold of either AST OR ALT would not meet eligibility)
For females of reproductive potential: negative pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all adverse events occurring through 30 days following last dose of inotuzumab ozogamicin.
Awards & highlights

ALL-001 Trial Summary

This trial will test a new cancer drug in kids with a certain kind of leukemia. Two different re-induction regimens will be used, with and without another cancer drug. Researchers will track how well the patients do.

Who is the study for?
This trial is for individuals aged 16-60 with relapsed/refractory B-cell acute lymphoblastic leukemia or lymphoma, CD-22 positive, and without major heart, liver, or kidney issues. They must be able to follow the study plan and agree to use contraception. Exclusions include active infections, prior stem cell transplant, certain heart conditions, allergies to asparaginase (for part 2), pregnancy/lactation, chronic liver disease/hepatitis B/C virus infection.Check my eligibility
What is being tested?
The trial tests different doses of Inotuzumab ozogamicin added to a re-induction regimen for treating B-cell ALL. It explores two regimens: one with pegaspargase and one without it. The focus is on how well patients respond to treatment including their survival rates and potential complications after stem cell transplants.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea/vomiting from chemotherapy drugs like Daunorubicin and Cytarabine; nerve damage from Vincristine; allergic reactions; blood clotting issues due to Pegaspargase; mouth sores from Methotrexate; weight gain/fluid retention from Prednisone.

ALL-001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney and liver functions are within the required limits.
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I am a woman who can have children and my pregnancy test is negative.
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I have CD-22 positive B-cell leukemia or lymphoma without the Philadelphia chromosome.
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I am between 16 and 60 years old.
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My cancer came back after initial treatment or didn't respond to it.
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I am able to get out of my bed or chair and move around.

ALL-001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all adverse events occurring through 30 days following last dose of inotuzumab ozogamicin.
This trial's timeline: 3 weeks for screening, Varies for treatment, and all adverse events occurring through 30 days following last dose of inotuzumab ozogamicin. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Characterization of Adverse Events (CTCAE version 5)
Dose-limiting toxicities
Informative course of treatment

ALL-001 Trial Design

2Treatment groups
Experimental Treatment
Group I: 4-drug re-induction regimen with inotuzumabExperimental Treatment7 Interventions
One cycle of a 4-drug regimen comprised of standard doses of prednisone, vincristine, daunorubicin, and pegaspargase with inotuzumab ozogamicin at a reduced dose. Intrathecal methotrexate (IT-methotrexate) and intrathecal cytarabine (IT-Ara-C) will be included for CNS prophylaxis. IV inotuzumab ozogamicin will be given at a reduced dose (may vary from a total cycle dose of 0.4 mg/m^2 to 0.9 mg/m^2)
Group II: 3-drug re-induction regimen with inotuzumabExperimental Treatment6 Interventions
One cycle of a 3-drug regimen comprised of standard doses of prednisone, vincristine, and daunorubicin with inotuzumab ozogamicin at a reduced dose. Intrathecal methotrexate (IT-methotrexate) and intrathecal cytarabine (IT-Ara-C) will be included for CNS prophylaxis. IV inotuzumab ozogamicin will be given at a reduced dose (may vary from a total cycle dose of 0.4 mg/m^2 to 0.9 mg/m^2)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daunorubicin
2013
Completed Phase 4
~4940
Methotrexate
2013
Completed Phase 4
~3800
Vincristine
2003
Completed Phase 4
~2910
Pegaspargase
2005
Completed Phase 3
~9010
Cytarabine
2016
Completed Phase 3
~3310

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonOTHER
1,182 Previous Clinical Trials
3,167,351 Total Patients Enrolled
Virginia Commonwealth UniversityOTHER
697 Previous Clinical Trials
22,884,960 Total Patients Enrolled
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,838 Total Patients Enrolled

Media Library

Inotuzumab ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03962465 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: 3-drug re-induction regimen with inotuzumab, 4-drug re-induction regimen with inotuzumab
Acute Lymphoblastic Leukemia Clinical Trial 2023: Inotuzumab ozogamicin Highlights & Side Effects. Trial Name: NCT03962465 — Phase 1
Inotuzumab ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03962465 — Phase 1

Frequently Asked Questions

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

How many patients are being accepted into this medical experiment?

"This clinical trial necessitates 36 eligible patients and is being run by the pharmaceutical company, Pfizer. The two primary sites are University of Virginia in Charlottesville, VA and Vanderbilt-Ingram Cancer Center in Nashville, TN."

Answered by AI

Does this clinical trial accept persons aged 55 and over as participants?

"This experiment requires that its participants are aged 16 to 60 years old. On the other hand, there 693 trials for minors and 1742 studies catering to those above 65 yrs of age."

Answered by AI

What potential risks may be associated with Inotuzumab ozogamicin treatment?

"A score of 1 was assigned to Inotuzumab ozogamicin, as Phase 1 trials are characterized by scant data on safety and efficacy."

Answered by AI

Are there any extant research efforts concerning Inotuzumab ozogamicin?

"Currently, there are 762 ongoing studies into Inotuzumab ozogamicin's efficacy with 206 trials in their 3rd phase. Many of these clinicaltrials occur in Changsha, Hunan; however, the medicine is being studied at over 32 thousand global trial sites."

Answered by AI

Is there any eligibility criteria that I must meet to be admitted into this experiment?

"This medical trial has an eligibility requirement that participants must have b-lymphocytes and be within the ages of 16 to 60. A total of 36 people need to enrol in order for this clinical study to go ahead."

Answered by AI

Is this research endeavor actively seeking participants?

"Affirmative. Reports from clinicaltrials.gov demonstrate that this scientific investigation, which was first shared on July 22nd 2022, is actively recruiting participants. 36 volunteers are needed for the trial at 4 different medical sites."

Answered by AI

Are there plentiful healthcare facilities performing this examination in Canada?

"At present, 4 sites are taking on participants for this clinical trial. Charlottesville, Nashville and Richmond boast one of these medical centres while the fourth is located in another urban hub. To minimise travel expenses, you should choose a location closest to your area if enrolling."

Answered by AI

What clinical conditions is Inotuzumab ozogamicin employed to address?

"Inotuzumab ozogamicin is indicated for the management of thyroiditis, neuroblastoma (NB), and pheochromocytomas."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL
Michael Douvas, MD 2022. "Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03962465.
~13 spots leftby Apr 2025
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