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Monoclonal Antibodies

inotuzumab ozogamicin-dose level 2 for Acute Lymphoblastic Leukemia

Phase 4
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years
Awards & highlights

Study Summary

This trial will study a lower dose of inotuzumab ozogamicin to see if it is safe and effective for patients with relapsed or refractory ALL.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • Leukemia
  • B-Cell Lymphoblastic Leukemia/Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 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
Percentage of Participants With Veno-occlusive Disease (VOD)
Rate of Hematologic Remission (Complete Response [CR] / Complete Response With Incomplete Hematologic Recovery[CRi])
Secondary outcome measures
Duration of Remission (DoR) in Participants Achieving CR/CRi
Mean Predose Concentrations (Ctrough) of Inotuzumab Ozogamicin
Number of Participant Received HSCT Post Inotuzumab Ozogamicin Treatment
+14 more

Side effects data

From 2023 Phase 4 trial • 102 Patients • NCT03677596
23%
Thrombocytopenia
23%
Pyrexia
23%
Alanine aminotransferase increased
18%
Neutropenia
18%
Neutrophil count decreased
18%
Aspartate aminotransferase increased
14%
Disease progression
14%
Febrile neutropenia
14%
Epistaxis
14%
Pneumonia
14%
Platelet count decreased
9%
Hypokalaemia
9%
Blood lactate dehydrogenase increased
9%
Influenza
9%
Hypertension
9%
Leukopenia
9%
Venoocclusive liver disease
9%
Fungal infection
9%
Sepsis
9%
Abdominal pain
9%
Anaemia
9%
Fatigue
5%
Hypomagnesaemia
5%
Anaemia megaloblastic
5%
Escherichia infection
5%
Upper respiratory tract infection
5%
Myelodysplastic syndrome
5%
Pneumonia klebsiella
5%
Tumour lysis syndrome
5%
Focal dyscognitive seizures
5%
Constipation
5%
Klebsiella test positive
5%
Septic shock
5%
Fungal sepsis
5%
Vomiting
5%
Gamma-glutamyltransferase increased
5%
Stomatitis
5%
Blood alkaline phosphatase increased
5%
Rash papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
1.2 mg/m²/Cycle (Dose Level 2 Run-in)
1.2 mg/m²/Cycle (Dose Level 2 Randomized Phase)
1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized)
1.8 mg/m²/Cycle (Dose Level 1 Randomized Phase)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dose Level 2Experimental Treatment1 Intervention
Inotuzumab ozogamicin at starting dose 1.2 mg/m2/cycle (administered in 3 divided doses). Most patients expected to receive 2 or 3 cycles (cycle length 21 to 28 days)
Group II: Dose Level 1Active Control1 Intervention
Inotuzumab ozogamicin at starting dose 1.8 mg/m2/cycle (administered in 3 divided doses). Most patients expected to receive 2 or 3 cycles (cycle length 21 to 28 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
inotuzumab ozogamicin-dose level 2
2019
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,772 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,940 Total Patients Enrolled

Frequently Asked Questions

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

What is the maximum number of participants that this research project can accommodate?

"As of November 21st, 2022 this clinical trial is not presently seeking any new candidates. The study was first posted on July 1st 2019 and has since been inactive. However, there are 1496 trials related to leukemia that are still recruiting patients as well as 17 studies involving inotuzumab ozogamicin-dose level 2 currently enrolling participants."

Answered by AI

Has the FDA officially sanctioned inotuzumab ozogamicin at dosage level 2?

"Via a scale rating from 1 to 3, our Power team assigned inotuzumab ozogamicin-dose level 2 with a score of 3 due its approval status as part of this Phase 4 trial."

Answered by AI

What conclusions have been derived from past experiments of inotuzumab ozogamicin-dose level 2?

"Inotuzumab ozogamicin at dose level 2 was initially tested in 2011 by the M D Anderson Cancer Center. Since then, 15 studies have come to a conclusion and 17 trials are still ongoing with several of them being conducted from Winston-Salem, North carolina."

Answered by AI

At what number of sites is this research initiative being conducted?

"Eleven clinical sites are carrying out this research, which include Winston-Salem, Omaha and Valhalla. To make the process easier for participants, it is recommended that they select a site close to their residence in order to reduce travel complications."

Answered by AI

What are the primary aims of this medical experiment?

"This trial's primary goal, which must be assessed over the course of two years from randomization, is to determine the Percentage of Participants With Hematologic Remission (CR/CRi). Secondary objectives include achieving Minimal Residual Disease (MRD) negativity through multiparametric flow cytometry scans of bone marrow aspirates and peripheral blood samples. Additionally, pharmacokinetics such as Clearance will also be considered alongside Post HSCT mortality."

Answered by AI

Are septuagenarians within the parameters of this investigation?

"This clinical trial requires participants to be aged between 18 and 75. However, there are 471 trials available for minors and 1,200 studies open to those above the age of 65 years old."

Answered by AI

Am I eligible to partake in the research initiative?

"The medical study is currently recruiting 102 leukemia patients whose ages range from 18 to 75. Prerequisites for participation include: having received or being eligible for Salvage 2 treatment, history of hepatic issues such as hepatitis and drug-induced liver damage, presence of lymphoblastic lymphoma with bone marrow involvement at a level ≥5% blasts by morphologic assessment, prior HSCT (hematopoietic stem cell transplantation), age 55+ years old, Ph+ ALL patients that have failed 1st/2nd generation tyrosine kinase inhibitor treatments plus standard multi agent induction chemotherapy in the case of late relapse during salvage 1 period"

Answered by AI

Are more participants being enrolled in this clinical research project?

"Unfortunately, this trial is not presently enrolling volunteers. Originally posted on July 1st 2019 and last updated on November 21st 2022, it has been put on hiatus for the time being. However, there are still 1496 trials searching for patients with leukemia and 17 studies looking to recruit individuals in dose level 2 of inotuzumab ozogamicin."

Answered by AI
~18 spots leftby Apr 2025