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Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TXAcute Lymphoblastic Leukemia+3 MoreInotuzumab Ozogamicin - Biological
Eligibility
18 - 70
All Sexes
What conditions do you have?
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Study Summary

This trial is testing the safety of a cancer drug called inotuzumab ozogamicin when given with other drugs before and after a stem cell transplant.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • Lymphoma
  • Lymphocytic Neoplasm

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Venetoclax
1
FT516
1
Allogeneic Hematopoietic Stem Cell Transplantation

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Acute graft versus host disease (GVHD)
Chronic GVHD
Overall survival (OS)
Progression-free survival (PFS)
Relapse
Treatment-related mortality (TRM)
Day 30
Incidence of grade 3 or higher renal, hepatic, cardiac, pulmonary, or neurologic toxicity

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Venetoclax
1
FT516
1
Allogeneic Hematopoietic Stem Cell Transplantation

Side Effects for

Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2
50%Fatigue
42%Constipation
42%Nausea
33%Vomiting
33%Thrombocytopenia
25%Aspartate aminotransferase increased
17%Neutropenia
17%Decreased appetite
17%Headache
8%Pain
8%Encephalopathy
8%Central nervous system neoplasm
8%Presyncope
8%Insomnia
8%Pruritus
8%Rash
8%Lymph node pain
8%Splenomegaly
8%Odynophagia
8%Catheter site erythema
8%Sinusitis
8%Dyspnoea exertional
8%Wheezing
8%Hyperkeratosis
8%Disease progression
8%Septic shock
8%Pyrexia
8%Oropharyngeal pain
8%Rhinorrhoea
8%Hypoaesthesia
8%Weight decreased
8%Tremor
8%Skin exfoliation
8%Influenza
8%Alanine aminotransferase increased
8%Bacteraemia
8%Blood creatinine increased
8%Anaemia
8%Conjunctival haemorrhage
8%Asthenia
8%Tonsillar hypertrophy
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT01363297) in the Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 ARM group. Side effects include: Fatigue with 50%, Constipation with 42%, Nausea with 42%, Vomiting with 33%, Thrombocytopenia with 33%.

Trial Design

2 Treatment Groups

Group I (inotuzumab ozogamicin, chemotherapy, transplant)
1 of 2
Group II (inotuzumab ozogamicin, chemotherapy, transplant)
1 of 2

Experimental Treatment

44 Total Participants · 2 Treatment Groups

Primary Treatment: Inotuzumab Ozogamicin · No Placebo Group · Phase 2

Group I (inotuzumab ozogamicin, chemotherapy, transplant)Experimental Group · 10 Interventions: Allogeneic Bone Marrow Transplantation, Methotrexate, Fludarabine, Inotuzumab Ozogamicin, Anti-Thymocyte Globulin, Peripheral Blood Stem Cell Transplantation, Melphalan, Tacrolimus, Filgrastim-sndz, Rituximab · Intervention Types: Procedure, Drug, Drug, Biological, Biological, Procedure, Drug, Drug, Biological, Biological
Group II (inotuzumab ozogamicin, chemotherapy, transplant)Experimental Group · 10 Interventions: Allogeneic Bone Marrow Transplantation, Methotrexate, Fludarabine, Inotuzumab Ozogamicin, Anti-Thymocyte Globulin, Bendamustine, Peripheral Blood Stem Cell Transplantation, Tacrolimus, Filgrastim-sndz, Rituximab · Intervention Types: Procedure, Drug, Drug, Biological, Biological, Drug, Procedure, Drug, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Bone Marrow Transplantation
2009
Completed Phase 2
~440
Methopterin
Not yet FDA approved
Fludarabine
FDA approved
Inotuzumab ozogamicin
FDA approved
Anti-Thymocyte Globulin
2009
Completed Phase 4
~950
Bendamustine
FDA approved
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1360
Mechlorethamine
FDA approved
Tacrolimus
FDA approved
Filgrastim
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,880 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,825 Previous Clinical Trials
1,792,527 Total Patients Enrolled
Issa F KhouriPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Adults between 18 and 35 years old with acute lymphoblastic leukemia (ALL) will only be included if they cannot undergo a high-dose chemotherapy and stem cell transplant.
References

Frequently Asked Questions

Is the upper age limit for this research experiment 45 years or older?

"The age range for potential participants spans from eighteen to seventy, as reflected in the study's eligibility requirements." - Anonymous Online Contributor

Unverified Answer

Could you please provide an estimate of the total participants involved in this trial?

"Affirmative. According to clinicaltrials.gov, this investigation is currently enrolling volunteers; it was originally announced on October 28th 2019 and the latest update happened on October 25th 2022. 44 people are expected to join from one medical centre." - Anonymous Online Contributor

Unverified Answer

What pathologies is Inotuzumab Ozogamicin prescribed to address?

"Inotuzumab Ozogamicin is typically employed to combat small cell lung cancer (sclc). However, it has also been seen as a viable therapy for dermatitis, atopic issues, multiple sclerosis and b-cell lymphomas." - Anonymous Online Contributor

Unverified Answer

Have any other trials been conducted to assess the efficacy of Inotuzumab Ozogamicin?

"At present, there is a large number of studies exploring the efficacy Inotuzumab Ozogamicin. Of those 1123 trials in progress, 208 have entered Phase 3 and are primarily based out of Philadelphia, Pennsylvania. However, clinical research sites across 27328 locations worldwide are examining this potential treatment option." - Anonymous Online Contributor

Unverified Answer

What risks do patients face when taking Inotuzumab Ozogamicin?

"Inotuzumab Ozogamicin was assigned a safety rating of 2, as there is evidence pointing to its secure use in this Phase 2 trial but no data supporting efficacy." - Anonymous Online Contributor

Unverified Answer

Is this research open to all interested individuals?

"To qualify, potential participants must have been diagnosed with lymphoma and be between 18-70 years of age. The study is aiming to recruit a total of 44 individuals." - Anonymous Online Contributor

Unverified Answer

Are there any remaining vacancies for participants in this research endeavor?

"Clinicaltrials.gov reveals that this clinical trial is actively seeking participants; the study was first posted on October 28th 2019 and most recently updated on October 25th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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