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NCT01925131 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Recurrent Adult Acute Lymphoblastic Leukemia and Recurrent Adult Burkitt Lymphoma, sponsored by SWOG Cancer Research Network.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target
5
Study locations

NCT01925131: Completed Phase 1 study of Recurrent Adult Acute Lymphoblastic Leukemia and Recurrent Adult Burkitt Lymphoma, sponsored by SWOG Cancer Research Network.

NCT01925131 is a Phase 1 study of Recurrent Adult Acute Lymphoblastic Leukemia and Recurrent Adult Burkitt Lymphoma that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 50 participants, below the 64-participant average among 8 other Recurrent Adult Acute Lymphoblastic Leukemia trials with a reported enrollment target (22% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01925131, a Phase 1 study of Recurrent Adult Acute Lymphoblastic Leukemia and Recurrent Adult Burkitt Lymphoma, has completed, sponsored by SWOG Cancer Research Network.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target
5
Study locations

Study Summary

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.

Primary Outcome

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.

Conditions Studied

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

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG prednisone
  • DRUG cyclophosphamide
  • DRUG vincristine sulfate
  • BIOLOGICAL inotuzumab ozogamicin

Study Locations (5)

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • Stanford Cancer Institute Palo Alto - Palo Alto

New York

  • University of Rochester - Rochester

Ohio

  • Cleveland Clinic Foundation - Cleveland

Texas

  • Ben Taub General Hospital - Houston

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2014-06-13
Est. Completion 2023-01-01
Phase Phase 1
SWOG Cancer Research Network

270 total trials

What the finished NCT01925131 record still lists

NCT01925131 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 64-participant average among 8 other Recurrent Adult Acute Lymphoblastic Leukemia trials with a reported enrollment target (22% lower).

The record links to 5 conditions, with Recurrent Adult Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.

NCT01925131 lists 5 locations in 4 states (California, New York, Ohio).

Frequently Asked Questions

What is clinical trial NCT01925131 about?

NCT01925131 is a clinical study titled "S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia". 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 differentia...

What is the current status of trial NCT01925131?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2014-06-13. Estimated completion is 2023-01-01.

What conditions does trial NCT01925131 study?

This clinical trial studies the following conditions: Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Burkitt Lymphoma, B-cell Adult Acute Lymphoblastic Leukemia, Acute Leukemias of Ambiguous Lineage, Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia.

What interventions are being tested in trial NCT01925131?

The interventions under investigation include: laboratory biomarker analysis (OTHER), prednisone (DRUG), cyclophosphamide (DRUG), vincristine sulfate (DRUG), inotuzumab ozogamicin (BIOLOGICAL).

Who is sponsoring clinical trial NCT01925131?

This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01925131 being conducted?

This trial has 5 study locations across California, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Recurrent Adult Acute Lymphoblastic Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01925131's enrollment target sits among peer trials

50 5th of 8 higher than 4 of 8 other Recurrent Adult Acute Lymphoblastic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Adult Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01925131, the US trial registry maintained by the National Library of Medicine. NCT01925131 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.