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Anti-tumor antibiotic

inotuzumab ozogamicin for Acute Leukemia

Phase 1
Waitlist Available
Led By Anjali Advani
Research Sponsored by Southwest Oncology Group
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 3 years
Awards & highlights

Study Summary

This trial is studying inotuzumab ozogamicin in combination with chemotherapy to treat patients with relapsed or refractory acute leukemia.

Eligible Conditions
  • Acute Leukemia
  • Acute Lymphoblastic Leukemia
  • Burkitt Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
MTD of Inotuzumab Ozogamicin With CVP for Patients With Relapsed or Refractory CD22+ Acute Leukemia
Secondary outcome measures
Frequency and Severity of Toxicities
Response Rate (CR+CRi) Among Expansion Cohort

Side effects data

From 2017 Phase 3 trial • 326 Patients • NCT01564784
49%
Thrombocytopenia
48%
Neutropenia
33%
Anaemia
32%
Nausea
30%
Pyrexia
29%
Leukopenia
27%
Headache
25%
Fatigue
23%
Aspartate aminotransferase increased
21%
Hyperbilirubinaemia
21%
Gamma-glutamyltransferase increased
19%
Lymphopenia
18%
Diarrhoea
17%
Constipation
16%
Febrile neutropenia
15%
Insomnia
15%
Alanine aminotransferase increased
15%
Hypokalaemia
15%
Vomiting
15%
Epistaxis
14%
Venoocclusive liver disease
13%
Blood alkaline phosphatase increased
13%
Cough
12%
Abdominal pain
12%
Decreased appetite
11%
Chills
10%
Back pain
9%
Asthenia
9%
Rash
9%
Lipase increased
8%
Oedema peripheral
8%
Pain in extremity
7%
Abdominal pain upper
7%
Hypocalcaemia
7%
Hypotension
7%
Fall
7%
Hyperglycaemia
7%
Dizziness
7%
Pain
6%
Hypomagnesaemia
6%
Hypoalbuminaemia
6%
Abdominal distension
6%
Dyspnoea
6%
White blood cell count decreased
6%
Pneumonia
6%
Contusion
5%
Arthralgia
5%
Hypophosphataemia
5%
Hypertension
5%
Disease progression
5%
Anxiety
5%
Pruritus
4%
Mucosal inflammation
4%
Oropharyngeal pain
4%
Erythema
4%
Tachycardia
3%
Stomatitis
3%
Hyponatraemia
2%
Sepsis
2%
Depression
2%
Sinusitis
2%
Septic shock
2%
Dyspepsia
2%
Chest pain
2%
Bacteraemia
2%
Bone pain
2%
Pleural effusion
2%
Neutropenic sepsis
1%
Staphylococcal bacteraemia
1%
Haemorrhage intracranial
1%
Respiratory failure
1%
Urinary tract infection fungal
1%
Pseudomonal sepsis
1%
Herpes zoster
1%
Influenza
1%
Neck pain
1%
Cholecystitis
1%
Pseudomonal bacteraemia
1%
Bone infarction
1%
Fungaemia
1%
Hepatic vein thrombosis
1%
Diverticulitis
1%
Systemic candida
1%
Sinusitis fungal
1%
Parainfluenzae virus infection
1%
Myocardial infarction
1%
Osteonecrosis
1%
Multiple organ dysfunction syndrome
1%
Febrile infection
1%
Urinary tract infection
1%
Infection
1%
Dermatitis allergic
1%
Dry eye
1%
Cardiac arrest
1%
Cardiac failure congestive
1%
Pericarditis
1%
Large intestinal ulcer
1%
Colitis ischaemic
1%
Intestinal ischaemia
1%
Mesenteric haemorrhage
1%
Pancreatitis
1%
Small intestinal obstruction
1%
Upper gastrointestinal haemorrhage
1%
Shock haemorrhagic
1%
Blindness unilateral
1%
Acute coronary syndrome
1%
Atrial fibrillation
1%
Adenoviral upper respiratory infection
1%
Brain abscess
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Clostridium difficile infection
1%
Corona virus infection
1%
Lung infection
1%
Subdural haematoma
1%
Fluid overload
1%
Lactic acidosis
1%
Tumour lysis syndrome
1%
Nervous system disorder
1%
Acute kidney injury
1%
Haematuria
1%
Acute respiratory distress syndrome
1%
Mucormycosis
1%
Abdominal pain lower
1%
Gastrointestinal haemorrhage
1%
Left ventricular dysfunction
1%
Ascites
1%
Lower gastrointestinal haemorrhage
1%
Gastritis haemorrhagic
1%
Intra-abdominal haemorrhage
1%
Serratia bacteraemia
1%
Enterococcal sepsis
1%
Escherichia sepsis
1%
Escherichia bacteraemia
1%
Candida infection
1%
Fungal infection
1%
Device related infection
1%
Respiratory tract infection
1%
Septic embolus
1%
Staphylococcal sepsis
1%
Enterococcal bacteraemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Inotuzumab Ozogamicin
Defined Investigator's Choice of Chemotherapy

Trial Design

6Treatment groups
Experimental Treatment
Group I: Treatment (combination chemotherapy and inotuzumab ozogamicin) - MTDExperimental Treatment5 Interventions
Combination chemotherapy and inotuzumab ozogamicin - Maximum Tolerated Dose Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Group II: Treatment (combination chemotherapy and inotuzumab ozogamicin) - Dose Level 5Experimental Treatment5 Interventions
Combination chemotherapy and inotuzumab ozogamicin - Dose level 5 Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Group III: Treatment (combination chemotherapy and inotuzumab ozogamicin) - Dose Level 4Experimental Treatment5 Interventions
Combination chemotherapy and inotuzumab ozogamicin - Dose level 4 Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on days 8 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Group IV: Treatment (combination chemotherapy and inotuzumab ozogamicin) - Dose Level 3Experimental Treatment5 Interventions
Combination chemotherapy and inotuzumab ozogamicin - Dose level 3 Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.8 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Group V: Treatment (combination chemotherapy and inotuzumab ozogamicin) - Dose Level 2Experimental Treatment5 Interventions
Combination chemotherapy and inotuzumab ozogamicin - Dose level 2 Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and inotuzumab ozogamicin IV over 1 hour at 0.6 mg/m2 on day 1 and 0.4 mg/m2 on day 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Group VI: Treatment (combination chemotherapy and inotuzumab ozogamicin) - Dose Level 1Experimental Treatment5 Interventions
Combination chemotherapy and inotuzumab ozogamicin - Dose level 1 Patients receive cyclophosphamide IV on day 1, vincristine sulfate IV on day 1, prednisone PO on days 1-5, and 0.4 mg/m2 inotuzumab ozogamicin IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cyclophosphamide
1994
Completed Phase 3
~8140
vincristine sulfate
1994
Completed Phase 3
~11270
prednisone
1999
Completed Phase 3
~10920
inotuzumab ozogamicin
2014
Completed Phase 3
~500

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,761 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,120 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,284 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment for this trial still open to the public?

"At present, this clinical trial is not recruiting patients. It was initially posted on April 1st 2014 and the most recent modification to its status occurred on April 4th 2022. Nonetheless, there are 3,531 other medical studies presently looking for volunteers."

Answered by AI

Which medical condition is inotuzumab ozogamicin typically used to combat?

"Inotuzumab ozogamicin is an effective intervention for lung cancer and other illnesses such as small cell lung carcinoma (SCLC), thyroiditis, and neuroblastoma (NB)."

Answered by AI

Have other investigations used inotuzumab ozogamicin?

"Currently, 1068 trials related to inotuzumab ozogamicin are active with 224 studies at the third and final stage. The largest concentration of research centers is located in Philadelphia, Pennsylvania; however, numerous other sites across the country have been conducting investigations as well."

Answered by AI

How many individuals is this research project recruiting?

"This trial has concluded its recruitment phase, with the first posting being on April 1st 2014 and a final edit occuring on April 4th 2022. If you are searching for other studies related to leukemia or inotuzumab ozogamicin there are presently 2463 and 1068 active clinical trials respectively."

Answered by AI

Has inotuzumab ozogamicin been certified by the FDA?

"Inotuzumab ozogamicin's safety has been minimally assessed, thus earning a score of 1 on the Power team's scale. This is consistent with it being in Phase 1 clinical trials and having limited data to back its efficacy."

Answered by AI

At how many sites is this scientific trial being conducted?

"This research is being conducted at the University of Rochester in Rochester, New york, Ben Taub General Hospital in Houston, Texas, and Cleveland Clinic Foundation in Cleveland Ohio. Additionally, there are 5 other active sites associated with this study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia
2014. "S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01925131.
~5 spots leftby Apr 2025
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