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NCT05303792 · ClinicalTrials.gov registry record · Phase 2

Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma

A Phase 2 study of B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma, sponsored by Alliance for Clinical Trials in Oncology.

Active
Registry status
Phase 2
Development phase
68
Enrollment target
20
Study locations

NCT05303792: Active Phase 2 study of B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma, sponsored by Alliance for Clinical Trials in Oncology.

NCT05303792 is a Phase 2 study of B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 68 participants, below the 1,024-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05303792, a Phase 2 study of B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
68 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs 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 with chemotherapy may help shrink the cancer and stop it from returning.

Primary Outcome

Will be evaluated using the methods of Kaplan-Meier as well as Cox regression models.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Dexamethasone
  • DRUG Vincristine
  • BIOLOGICAL Inotuzumab Ozogamicin
  • DRUG Methotrexate

Study Locations (20)

Idaho

  • Saint Alphonsus Cancer Care Center-Boise - Boise
  • Saint Luke's Cancer Institute - Boise - Boise
  • Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
  • Kootenai Health - Coeur d'Alene - Coeur d'Alene
  • Saint Alphonsus Cancer Care Center-Nampa - Nampa
  • Kootenai Clinic Cancer Services - Post Falls - Post Falls
  • Kootenai Clinic Cancer Services - Sandpoint - Sandpoint

Illinois

  • Northwestern University - Chicago
  • University of Chicago Comprehensive Cancer Center - Chicago
  • NorthShore University HealthSystem-Evanston Hospital - Evanston
  • NorthShore University HealthSystem-Glenbrook Hospital - Glenview
  • NorthShore University HealthSystem-Highland Park Hospital - Highland Park
  • Loyola University Medical Center - Maywood
  • UC Comprehensive Cancer Center at Silver Cross - New Lenox

California

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
  • Stanford Cancer Institute Palo Alto - Palo Alto

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Connecticut

  • Yale University - New Haven

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2023-06-09
Est. Completion 2028-05
Phase Phase 2

What the registry record for NCT05303792 still lists

NCT05303792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 1,024-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (93% lower).

The record links to 2 conditions, with B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT05303792 names 20 study sites across 6 states, led by Idaho, Illinois, California.

Frequently Asked Questions

What is clinical trial NCT05303792 about?

NCT05303792 is a clinical study titled "Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma". This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called...

What is the current status of trial NCT05303792?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2023-06-09. Estimated completion is 2028-05.

What conditions does trial NCT05303792 study?

This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma.

What interventions are being tested in trial NCT05303792?

The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Vincristine (DRUG), Inotuzumab Ozogamicin (BIOLOGICAL), Methotrexate (DRUG).

Who is sponsoring clinical trial NCT05303792?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05303792 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for B 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 NCT05303792's enrollment target sits among peer trials

68 11th of 20 higher than 10 of 20 other B Acute Lymphoblastic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other B 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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Source: ClinicalTrials.gov NCT05303792, the US trial registry maintained by the National Library of Medicine. NCT05303792 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.