Who is sponsoring NCT01925131?

NCT01925131 is sponsored by SWOG Cancer Research Network.

What drugs are being tested in NCT01925131?

Interventions in NCT01925131: cyclophosphamide, vincristine sulfate, prednisone, inotuzumab ozogamicin, laboratory biomarker analysis.

What condition does NCT01925131 study?

NCT01925131 studies Acute Leukemias of Ambiguous Lineage, B-cell Adult Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Burkitt Lymphoma.

Is NCT01925131 still recruiting?

NCT01925131 is currently completed. Last updated 3 May 2023.

Are results published for NCT01925131?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-05-03 · How we verify

NCT01925131

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia

Completed Phase 1 Results posted Last updated 3 May 2023

What this trial tests

Phase 1 trial testing cyclophosphamide in Acute Leukemias of Ambiguous Lineage in 50 participants. Completed in 1 January 2023.

Timeline

13 June 2014

Primary endpoint
1 January 2022

1 January 2023

Quick facts

Lead sponsor	SWOG Cancer Research Network
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	13 June 2014
Primary completion	1 January 2022
Estimated completion	1 January 2023
Sites	5 locations across United States

Drugs / interventions tested

cyclophosphamide (cyclophosphamide) — full drug profile →
vincristine sulfate (Vincristine Sulfate) — full drug profile →
prednisone (prednisone) — full drug profile →
inotuzumab ozogamicin — full drug profile →
laboratory biomarker analysis

Conditions studied

Acute Leukemias of Ambiguous Lineage — all drugs for Acute Leukemias of Ambiguous Lineage →
B-cell Adult Acute Lymphoblastic Leukemia — all drugs for B-cell Adult Acute Lymphoblastic Leukemia →
Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia — all drugs for Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia →
Recurrent Adult Acute Lymphoblastic Leukemia — all drugs for Recurrent Adult Acute Lymphoblastic Leukemia →

Sponsor

SWOG Cancer Research Network

Who can join

18 and older, any sex, with Acute Leukemias of Ambiguous Lineage or B-cell Adult Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

MTD of Inotuzumab Ozogamicin With CVP for Patients With Relapsed or Refractory CD22+ Acute Leukemia Primary · 28 days

To determine the maximum tolerated dose (MTD) of inotuzumab ozogamicin in this regimen for patients with relapsed or refractory CD22+ acute leukemia (B-cell acute lymphoblastic leukemia \[B-ALL\], mixed phenotype, and Burkitt's). The MTD is defined as the highest dose studied in which the incidence of dose-limiting toxicities is \< 33% using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.

Day 1 Dose

Group	Value	95% CI
CVP + Inotuzumab	0.8

Day 8 Dose

Group	Value	95% CI
CVP + Inotuzumab	0.5

Day 15 Dose

Group	Value	95% CI
CVP + Inotuzumab	0.5

Response Rate (CR+CRi) Among Expansion Cohort Secondary · Up to 3 years

The response rate (CR + CRi) is defined as the rate of complete remission (CR) + complete remission with incomplete count recovery (CRi). Complete remission (CR) is defined as \< 5% marrow aspirate blasts, neutrophils ≥ 1000/uL, platelets \> 100,000/uL, no blasts in peripheral blood, and C1 Extramedullary disease status. C1 Extramedullary disease status is characterized by complete disappearance of all measurable and non-measurable extramedullary disease with the exception of lesions for which the following must be true: for participants with at least one measurable lesion, all lesions must ha

Group	Value	95% CI
CVP + Inotuzumab MTD	83.33

Frequency and Severity of Toxicities Secondary · Up to 3 years

Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported by given type of adverse event.

Anemia

Group	Value	95% CI
CVP + Inotuzumab Dose Level 1	2
CVP + Inotuzumab Dose Level 2	2
CVP + Inotuzumab Dose Level 3	7
CVP + Inotuzumab Dose Level 4	3
CVP + Inotuzumab Dose Level 5	5
CVP + Inotuzumab MTD	5

Ascites

Group	Value	95% CI
CVP + Inotuzumab Dose Level 1	0
CVP + Inotuzumab Dose Level 2	0
CVP + Inotuzumab Dose Level 3	0
CVP + Inotuzumab Dose Level 4	0
CVP + Inotuzumab Dose Level 5	1
CVP + Inotuzumab MTD	1

Dysphagia

Group	Value	95% CI
CVP + Inotuzumab Dose Level 1	0
CVP + Inotuzumab Dose Level 2	0
CVP + Inotuzumab Dose Level 3	1
CVP + Inotuzumab Dose Level 4	0
CVP + Inotuzumab Dose Level 5	0
CVP + Inotuzumab MTD	0

Encephalopathy

Group	Value	95% CI
CVP + Inotuzumab Dose Level 1	0
CVP + Inotuzumab Dose Level 2	0
CVP + Inotuzumab Dose Level 3	1
CVP + Inotuzumab Dose Level 4	0
CVP + Inotuzumab Dose Level 5	0
CVP + Inotuzumab MTD	0

Enterocolitis

Group	Value	95% CI
CVP + Inotuzumab Dose Level 1	0
CVP + Inotuzumab Dose Level 2	0
CVP + Inotuzumab Dose Level 3	0
CVP + Inotuzumab Dose Level 4	0
CVP + Inotuzumab Dose Level 5	1
CVP + Inotuzumab MTD	0

Fatigue

Group	Value	95% CI
CVP + Inotuzumab Dose Level 1	0
CVP + Inotuzumab Dose Level 2	0
CVP + Inotuzumab Dose Level 3	1
CVP + Inotuzumab Dose Level 4	0
CVP + Inotuzumab Dose Level 5	0
CVP + Inotuzumab MTD	1

Febrile neutropenia

Group	Value	95% CI
CVP + Inotuzumab Dose Level 1	0
CVP + Inotuzumab Dose Level 2	2
CVP + Inotuzumab Dose Level 3	2
CVP + Inotuzumab Dose Level 4	3
CVP + Inotuzumab Dose Level 5	1
CVP + Inotuzumab MTD	7

Fever

Group	Value	95% CI
CVP + Inotuzumab Dose Level 1	1
CVP + Inotuzumab Dose Level 2	1
CVP + Inotuzumab Dose Level 3	1
CVP + Inotuzumab Dose Level 4	0
CVP + Inotuzumab Dose Level 5	0
CVP + Inotuzumab MTD	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 3 years post registration. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CVP + Inotuzumab Dose Level 1

Serious: 2/5 (40%)

Deaths: 4/5

CVP + Inotuzumab Dose Level 2

Serious: 2/4 (50%)

Deaths: 3/4

CVP + Inotuzumab Dose Level 3

Serious: 4/10 (40%)

Deaths: 9/10

CVP + Inotuzumab Dose Level 4

Serious: 1/5 (20%)

Deaths: 5/5

CVP + Inotuzumab Dose Level 5

Serious: 1/11 (9%)

Deaths: 9/11

CVP + Inotuzumab MTD

Serious: 11/13 (85%)

Deaths: 8/13

Serious adverse events (29 terms)

Reaction	System	CVP + Inotuzumab Dose Leve…	CVP + Inotuzumab Dose Leve…	CVP + Inotuzumab Dose Leve…	CVP + Inotuzumab Dose Leve…	CVP + Inotuzumab Dose Leve…	CVP + Inotuzumab MTD
Infections and infestations-Other	Infections and infestations	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—
Gastric hemorrhage	Gastrointestinal disorders	—	—	—	—	—	—
Gastrointestinal disorders-Other	Gastrointestinal disorders	—	—	—	—	—	—
Edema face	General disorders	—	—	—	—	—	—
Facial pain	General disorders	—	—	—	—	—	—
Fever	General disorders	—	—	—	—	—	—
Lung infection	Infections and infestations	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—
Upper respiratory infection	Infections and infestations	—	—	—	—	—	—
Investigations-Other	Investigations	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Encephalopathy	Nervous system disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Intracranial hemorrhage	Nervous system disorders	—	—	—	—	—	—
Nervous system disorders-Other	Nervous system disorders	—	—	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—
Renal and urinary disorders-Other	Renal and urinary disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—

Other adverse events (193 terms — click to expand)

Reaction	System	CVP + Inotuzumab Dose Leve…	CVP + Inotuzumab Dose Leve…	CVP + Inotuzumab Dose Leve…	CVP + Inotuzumab Dose Leve…	CVP + Inotuzumab Dose Leve…	CVP + Inotuzumab MTD
Anemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—
White blood cell decreased	Investigations	—	—	—	—	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Edema limbs	General disorders	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Infections and infestations-Other	Infections and infestations	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—	—
Gastrointestinal disorders-Other	Gastrointestinal disorders	—	—	—	—	—	—
Fever	General disorders	—	—	—	—	—	—
General disorders and admin site conditions - Other	General disorders	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—	—	—	—
Hypoglycemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Hypomagnesemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—

Most-reported serious reactions: Infections and infestations-Other, Fatigue, Anemia, Febrile neutropenia, Sinus tachycardia, Ascites, Gastric hemorrhage, Gastrointestinal disorders-Other.

Data from ClinicalTrials.gov NCT01925131 adverse events section.

Sponsor's own description

This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given together with combination chemotherapy in treating patients with relapsed or refractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express cluster of differentiation (CD)22 and kill them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving inotuzumab ozogamicin together with combination chemotherapy may kill more cancer cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Acquired Resistance to Antibody-Drug Conjugates.
Collins DM, Bossenmaier B, Kollmorgen G, Niederfellner G. · · 2019 · cited 109× · PMID 30897808 · DOI 10.3390/cancers11030394
Inotuzumab ozogamicin in adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia: a phase 1/2 study.
DeAngelo DJ, Stock W, Stein AS, Shustov A, et al · · 2017 · cited 107× · PMID 29296758 · DOI 10.1182/bloodadvances.2016001925
Vincristine in Combination Therapy of Cancer: Emerging Trends in Clinics.
Škubník J, Pavlíčková VS, Ruml T, Rimpelová S. · · 2021 · cited 86× · PMID 34571726 · DOI 10.3390/biology10090849
CD22 Expression in B-Cell Acute Lymphoblastic Leukemia: Biological Significance and Implications for Inotuzumab Therapy in Adults.
Lanza F, Maffini E, Rondoni M, Massari E, et al · · 2020 · cited 54× · PMID 32012891 · DOI 10.3390/cancers12020303
Targeting CD22 for the Treatment of B-Cell Malignancies.
Shah NN, Sokol L. · · 2021 · cited 42× · PMID 34262884 · DOI 10.2147/itt.s288546
Advances in biology of acute lymphoblastic leukemia (ALL) and therapeutic implications.
Mohseni M, Uludag H, Brandwein JM. · · 2018 · cited 34× · PMID 30697448
Treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia in Adults.
Saleh K, Fernandez A, Pasquier F. · · 2022 · cited 24× · PMID 35406576 · DOI 10.3390/cancers14071805
Inotuzumab ozogamicin in clinical development for acute lymphoblastic leukemia and non-Hodgkin lymphoma.
Aujla A, Aujla R, Liu D. · · 2019 · cited 23× · PMID 31011424 · DOI 10.1186/s40364-019-0160-4

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01925131 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SWOG Cancer Research Network
Last refreshed: 3 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01925131.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing