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Alkylating agents

Inotuzumab Ozogamicin for B-Cell Lymphoma

Phase 1
Waitlist Available
Led By Ryan Cassaday
Research Sponsored by University of Washington
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 up to 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining a monoclonal antibody with chemotherapy to see if it's more effective than chemo alone at treating patients with B-cell acute lymphoblastic leukemia that has come back or stopped responding to treatment.

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Maximum tolerated dose (MTD) of inotuzumab ozogamicin (InO)
Secondary outcome measures
Complete response (CR) rate
Overall survival
Progression-free survival
+3 more

Side effects data

From 2016 Phase 2 trial • 72 Patients • NCT01363297
50%
Fatigue
42%
Nausea
42%
Constipation
33%
Thrombocytopenia
33%
Vomiting
25%
Aspartate aminotransferase increased
17%
Neutropenia
17%
Decreased appetite
17%
Headache
8%
Tremor
8%
Tonsillar hypertrophy
8%
Disease progression
8%
Conjunctival haemorrhage
8%
Skin exfoliation
8%
Wheezing
8%
Encephalopathy
8%
Central nervous system neoplasm
8%
Lymph node pain
8%
Dyspnoea exertional
8%
Presyncope
8%
Asthenia
8%
Pain
8%
Insomnia
8%
Pruritus
8%
Rash
8%
Splenomegaly
8%
Catheter site erythema
8%
Sinusitis
8%
Hyperkeratosis
8%
Odynophagia
8%
Septic shock
8%
Pyrexia
8%
Oropharyngeal pain
8%
Rhinorrhoea
8%
Hypoaesthesia
8%
Weight decreased
8%
Influenza
8%
Alanine aminotransferase increased
8%
Bacteraemia
8%
Blood creatinine increased
8%
Anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2
Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2
Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2
Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2
Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose 3 (0.6 mg/m^2, 0.3 mg/m^2)Experimental Treatment6 Interventions
Dose 3 patients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Dose 2 (0.6 mg/m^2, 0.3 mg/m^2)Experimental Treatment6 Interventions
Dose 2 patients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Group III: Dose 1 (0.3 mg/m^2)Experimental Treatment6 Interventions
Dose 1 patients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Group IV: Dose -1 (0.3 mg/m^2)Experimental Treatment6 Interventions
Patients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on day 8. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Prednisone
2014
Completed Phase 4
~2370
Cyclophosphamide
1995
Completed Phase 3
~3780
Vincristine
2003
Completed Phase 4
~2920
Doxorubicin
2012
Completed Phase 3
~7940
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,726 Previous Clinical Trials
1,821,293 Total Patients Enrolled
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,659 Total Patients Enrolled
Ryan CassadayPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
2 Previous Clinical Trials
12 Total Patients Enrolled

Frequently Asked Questions

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

How does this research compare to prior experiments of its genre?

"Inotuzumab Ozogamicin has been subject to scientific inquiry since 1997, when Alfacell sponsored a study involving 300 participants. After passing Phase 3 drug approval trials, the medication is currently being researched in 1440 different clinical studies across 81 nations and 3003 cities worldwide."

Answered by AI

Has Inotuzumab Ozogamicin obtained regulatory approval from the FDA?

"We rate the safety of Inotuzumab Ozogamicin a 1, as this is an early-phase trial with limited evidence on both efficacy and safety."

Answered by AI

What ailments commonly benefit from the application of Inotuzumab Ozogamicin?

"Inotuzumab Ozogamicin can be utilized as a form of therapy for prostate cancer, pheochromocytomas, and ulcerative colitis."

Answered by AI

Could you elucidate on any other research conducted regarding Inotuzumab Ozogamicin?

"Currently, 1440 clinical trials are dedicated to Inotuzumab Ozogamicin with 322 of those studies having advanced into Phase 3. These research sites have been dispersed across 54 469 locations and the majority can be found in Bethesda, Maryland."

Answered by AI

Is this clinical investigation currently accepting participants?

"This particular study has ceased participant recruitment. It was posted on September 24th 2019 and last updated on the 21st of September 2022. If one is in search of other trials, there are 3727 clinical studies for lymphoma patients currently recruiting and 1440 for Inotuzumab Ozogamicin specifically accepting participants."

Answered by AI

What is the current cohort size of this experiment?

"Unfortunately, this clinical trial is currently not accepting participants at present. The initial posting was on September 24th 2019 and the last edit occured on September 21st 2022. However, there are 3727 trials for lymphoma active enrollment and 1440 studies recruiting patients with Inotuzumab Ozogamicin respectively."

Answered by AI
~4 spots leftby Mar 2025