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Monoclonal Antibodies

Inotuzumab Ozogamicin and Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia

Phase 1 & 2
Waitlist Available
Led By Eunice S Wang
Research Sponsored by Roswell Park Cancer Institute
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 12 months after last dose of study treatment
Awards & highlights
No Placebo-Only Group

Summary

This phase Ib/II trial studies side effects and best dose of inotuzumab ozogamicin and how well it works when given together with vincristine sulfate liposome in treating patients with CD22 positive (+) B-cell acute lymphoblastic leukemia that has come back or dose not respond to treatment. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22+ cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as vincristine sulfate liposome, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin and vincristine sulfate liposome together may work better in treating patients with CD22+ B-cell acute lymphoblastic leukemia compared to giving inotuzumab ozogamicin or vincristine sulfate liposome alone.

Eligible Conditions
  • Childhood Leukemia
  • B Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Acute lymphoblastic leukemia
  • Hematopoietic Stem Cell Transplant Recipient
  • Acute Leukemia
  • B-Cell Acute Lymphoblastic Leukemia (ALL)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from enrollment until disease progression/recurrence, death due to any cause, or last follow-up, assessed up to 12 months after last dose of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from enrollment until disease progression/recurrence, death due to any cause, or last follow-up, assessed up to 12 months after last dose of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose-limiting toxicities (DLTs) (Phase Ib)
Incidence of adverse events (AEs)
Overall response rate (ORR) (Phase II)
Secondary study objectives
Leukemia-free survival (LFS)
Number of patients who developed subsequent neurological toxicities and VOD
Number of patients who proceed onto subsequent hematopoietic stem cell transplantation (HSCT)
+1 more
Other study objectives
Change in quality of life (QOL)

Side effects data

From undefined Phase 3 trial • 1734 Patients • NCT00025259
80%
Neutrophil count decreased
42%
Anemia
31%
Platelet count decreased
26%
Febrile neutropenia
18%
White blood cell decreased
16%
Infections and infestations - Other, specify
9%
Blood and lymphatic system disorders - Other, specify
5%
Lymphocyte count decreased
3%
Catheter related infection
3%
Dehydration
2%
Abdominal pain
2%
Mucositis oral
2%
Vomiting
2%
Anaphylaxis
2%
Hypokalemia
2%
Hypotension
1%
Hyponatremia
1%
Hypoxia
1%
Myalgia
1%
Depression
1%
Immune system disorders - Other, specify
1%
Dizziness
1%
Constipation
1%
Esophagitis
1%
Ileus
1%
Pain
1%
Carbon monoxide diffusing capacity decreased
1%
Hypoalbuminemia
1%
Neuralgia
1%
Peripheral sensory neuropathy
1%
Dyspnea
1%
Diarrhea
1%
Typhlitis
1%
Hyperglycemia
1%
Headache
1%
Seizure
1%
Syncope
1%
Nausea
1%
Cardiac disorders - Other, specify
1%
Hypophosphatemia
1%
Bone pain
1%
Peripheral motor neuropathy
1%
Thromboembolic event
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm III (RER With CR [ABVE-PC])
Arm I (Patients Off-therapy Before Callback-Induction Only)
Arm II (RER With CR [ABVE-PC, IFRT])
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
Arm VII (SER [ABVE-PC, IFRT])
Arm VI (SER [DECA, ABVE-PC, IFRT])
Arm V (RER With PD)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (inotuzumab ozogamicin, liposomal vincristine)Experimental Treatment3 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine Sulfate Liposome
2010
Completed Phase 3
~2580
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
414 Previous Clinical Trials
33,722 Total Patients Enrolled
PfizerIndustry Sponsor
4,675 Previous Clinical Trials
28,717,182 Total Patients Enrolled
Eunice S WangPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
24 Total Patients Enrolled
~0 spots leftby Jan 2026
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