New combo therapy aims to outsmart leukemia in older patients

NCT ID NCT05303792

Disease control Sponsor: Alliance for Clinical Trials in Oncology Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This phase II trial is testing whether adding a targeted drug called inotuzumab ozogamicin to standard chemotherapy can help older adults with B-cell acute lymphoblastic leukemia or lymphoma. The study compares the combination to standard chemo alone in 68 participants. The goal is to see if the combo improves event-free survival and helps keep the cancer from coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Inotuzumab ozogamicin (a targeted antibody-drug conjugate) combined with chemotherapy drugs (cyclophosphamide, vincristine, dexamethasone, methotrexate, cytarabine, methylprednisolone, rituximab, prednisone, mercaptopurine, doxorubicin)
What this could lead to: If it works, this could point toward a more effective treatment option for older adults with B-cell acute lymphoblastic leukemia, potentially improving the chance of keeping the cancer from returning.
What could go wrong: This is a phase II trial with only 68 participants, so results are preliminary. The combination may cause more side effects than standard chemo, and it is not yet known if it will improve long-term survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

68 people

The number who actually took part.

Started

Jun 2023

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0) * Research bone marrow or peripheral blood submission \* This bone marrow or peripheral blood submission is mandatory prior to registration/randomization as baseline for real-time MRD analysis. The bone marrow sample should be from the first aspiration (i.e., first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be obtained as soon after pre-registration as possible * REGISTRATION ELIGIBILITYCRITERIA (STEP 1) * Diagnosis of B-cell acute lymphoblastic leukemia (ALL) per World Health Organization (WHO) 2016 criteria. Patients must have \>= 20% blasts in the bone marrow or blood. Patients with lymphoblastic lymphoma (LBL) with \<20% blasts in the marrow are permitted. \* T-cell ALL/LBL, Philadelphia-chromosome positive B-cell (as determined by fluorescence in situ hybridization \[FISH\], cytogenetics, or reverse transcriptase polymerase chain reaction \[RT-PCR\]), and Burkitt's like leukemia/lymphoma (mature B-ALL) are not eligible * Must be CD22 positive by local assessment (\>= 20% by immunohistochemistry or flow cytometry). Patients are eligible regardless of CD20 status but CD20 expression should be assessed at diagnosis by flow cytometry or immunohistochemistry * Patients with symptomatic central nervous system (CNS) disease are not eligible. CNS assessment is not required for eligibility determination if asymptomatic * Patients must have \>= 5% blasts in the bone marrow or blood. Patients with lymphoblastic lymphoma (LBL) without marrow involvement (\>= 5% blasts) are not eligible * No prior chemotherapy for ALL except for hydroxyurea (no limit), steroids limited to 7 days, ATRA (no limit), vincristine (single dose), and/or intra-thecal chemotherapy. Leukapheresis is permitted. Palliative radiation to doses 24 Gy or less is permitted. Patients being treated with chronic steroids for other reasons (autoimmune disorder, etc.) are eligible * Age \>= 50 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2. ECOG 3 permitted if related to disease * Creatinine =\< 2.0 g/dL * Total bilirubin =\< 1.5 x upper limit of normal (ULN) \* Except in the event of: 1) Gilbert disease, in which case total bilirubin must be =\< 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be =\< 2 x ULN * AST / ALT =\< 2.5 x upper limit of normal (ULN) * Cardiac ejection fraction (as measured by multigated acquisition scan \[MUGA\] or echocardiogram) \> 40% * No clinically relevant liver disease (such as cirrhosis, active hepatitis, alcohol use disorder or sinusoidal occlusive syndrome), which in the opinion of the treating physician would make this protocol unreasonably hazardous * Patients with known hepatitis B virus (HBV) infection are eligible if they are on effective HBV suppressive therapy with undetectable HBV viral load and there is no clinically relevant liver disease present (related or unrelated to HBV-related liver damage) * Patients with known history of hepatitis C virus (HCV) infection are eligible if they have cleared the infection spontaneously or via eradication therapy (HCV viral load undetectable) and there is no clinically relevant liver disease present (related or unrelated to HCV-related liver damage) * Physicians should consider whether any of the following may render the patient inappropriate for this protocol: * Medical condition such as uncontrolled diabetes mellitus, uncontrolled cardiac disease, and uncontrolled pulmonary disease. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Patients with a "currently active" second malignancy other than non-melanoma skin cancers, early stage prostate cancer, cervical carcinoma in situ, or other cancer for which standard of care would be observation (not requiring treatment). Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for \>= 1 year, or if the cancer has been surgically resected and considered cured. Patients with a history of multiple myeloma with absence of serum paraprotein for \>= 1 year are not considered to have a "currently active" malignancy. * Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Include as applicable: Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom) Exclusion Criteria: * Physicians should consider whether any of the following may render the patient inappropriate for this protocol: * Medical condition such as uncontrolled diabetes mellitus, uncontrolled cardiac disease, and uncontrolled pulmonary disease. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Patients with a "currently active" second malignancy other than non-melanoma skin cancers, early stage prostate cancer, cervical carcinoma in situ, or other cancer for which standard of care would be observation (not requiring treatment). Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for \>= 1 year, or if the cancer has been surgically resected and considered cured. Patients with a history of multiple myeloma with absence of serum paraprotein for \>= 1 year are not considered to have a "currently active" malignancy. * REGISTRATION EXCLUSION CRITERIA (STEP 1) * Patients with symptomatic central nervous system (CNS) disease are not eligible. CNS assessment is not required for eligibility determination if asymptomatic

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia Burkitt lymphoma lymphoblastic lymphoma Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B acute lymphoblastic leukemia B lymphoblastic lymphoma

Contacts and locations

Locations

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States
Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States
Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Billings Clinic Cancer Center

Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States
Community Hospital of Anaconda

Anaconda, Montana, 59711, United States
Community Medical Center

Missoula, Montana, 59804, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States
Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States
Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864, United States
Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States
Logan Health Medical Center

Kalispell, Montana, 59901, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States
Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Memorial Hospital East

Shiloh, Illinois, 62269, United States
Mount Sinai Hospital

New York, New York, 10029, United States
Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123, United States
Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118, United States
North Shore University Hospital

Manhasset, New York, 11030, United States
NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States
NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026, United States
NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035, United States
Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States
Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States
Northwestern University

Chicago, Illinois, 60611, United States
Norton Suburban Hospital and Medical Campus

Louisville, Kentucky, 40207, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Oregon Health and Science University

Portland, Oregon, 97239, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States
Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States
Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States
Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914, United States
Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States
San Juan City Hospital

San Juan, 00936, Puerto Rico
Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States
Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States
Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States
UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States
University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Rochester

Rochester, New York, 14642, United States
University of Vermont Medical Center

Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States
Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States
Yale University

New Haven, Connecticut, 06520, United States

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