New combo attack on leukemia: chemo plus targeted drug shows promise

NCT ID NCT00792948

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This phase II trial is studying a combination of chemotherapy (Hyper-CVAD) and the targeted drug dasatinib, with or without a donor stem cell transplant, in 97 adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL). The goal is to see how well this approach controls the disease and improves relapse-free survival. Participants first receive the chemo-drug combo, and some may then get a stem cell transplant to further attack any remaining cancer cells.

What this could mean

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

Active substance: Dasatinib (a targeted cancer drug) and combination chemotherapy (Hyper-CVAD)
What this could lead to: If successful, this approach could offer a more effective way to control Ph+ ALL and improve long-term remission rates.
What could go wrong: This is a phase II trial with only 97 participants, so results may not apply to everyone. The treatments have significant side effects, and the stem cell transplant carries risks like graft-versus-host disease.

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

97 people

The number who actually took part.

Started

Sep 2009

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 60 years

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: * INDUCTION/CONSOLIDATION REGISTRATION: * Patients must have a morphologic diagnosis of acute lymphoblastic leukemia (ALL), with evidence of ALL involvement in bone marrow and/or blood; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible; patients with M0 acute myeloid leukemia (AML) or mixed lineage leukemia are not eligible for this study; patients with L3 (Burkitts) are also not eligible * For ALL in marrow or peripheral blood, immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T-cell, or mixed B/T cell); NOTE: appropriate marker studies including cluster of differentiation (CD)19 (B cell), CD10, CD5, and CD7 (T cell) must be performed; co-expression of myeloid antigens (CD13 and CD33) will not exclude patients; if possible, the lineage specific markers cytoplasmic CD22 or CD79a (B cells), cytoplasmic CD3 (T cells) and cytoplasmic myeloperoxidase (MPO) (myeloid cells) must be determined * Patients may have received no more than one course of remission induction therapy for ALL; patients who have received any post-remission therapy for ALL or who have relapsed from complete remission are not eligible; (patients with previously untreated ALL can be eligible, and patients who have received one course of remission induction therapy for ALL can be eligible, regardless of their response to therapy); patients may have received no more than 14 days of tyrosine kinase inhibitor therapy prior to registration; any prior induction chemotherapy must have been completed no more than 28 days prior to registration * NOTE: If the patient has been initiated on the protocol defined regimen (i.e. the hyper-CVAD regimen without a tyrosine kinase inhibitor) before the Philadelphia chromosome (Ph)/BCR-ABL status was known, the patient may be registered on the protocol and start dasatinib; in this first course, dasatinib will be administered up to day 14 (i.e. if the patient is registered on day 5 and starts therapy on day 6, only 8 days of dasatinib will be administered and dasatinib will be completed on day 14) * For patients who have received any prior therapy that was NOT remission induction therapy, one of the following must be true: * At least 6 weeks must have elapsed since any monoclonal antibodies were given, at least 7 days must have elapsed since any other treatment was given, and all toxicities of the remission induction therapy must have resolved to grade =\< 2 * The patient must have rapidly progressive disease (per institutional guidelines) * For previously treated patients, the study chair must be contacted before registration, in order to determine the regimen to be given in the first course of induction/consolidation therapy, based on prior therapy * Patients must be Philadelphia (Ph) positive and/or BCR/ABL positive as confirmed by standard cytogenetics, fluorescent in situ hybridization (FISH), and/or polymerase chain reaction (PCR) testing performed by local laboratory; NOTE: samples will be submitted centrally for verification of results * Patients must have a bilirubin =\< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration * Patients must have serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 3.0 x IULN and/or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3.0 x IULN within 14 days prior to registration; if both tests are done then both values must be =\< 3.0 x IULN * Patients must have a serum creatinine =\< 3.0 x IULN within 14 days prior to registration * Patients must not have active pericardial effusion, ascites, or pleural effusion of any grade; exception: if the effusion is suspected to be related to the leukemia, the patient may have pericardial effusion of =\< grade 2 or pleural effusion =\< grade 1 * Patients may not have any clinically significant cardiovascular disease including the following: * Myocardial infarction or ventricular tachyarrhythmia within 6 months * Prolonged corrected QT (QTc) \>= 480 msec (Fridericia correction) * Ejection fraction less than institutional normal * Major conduction abnormality (unless a cardiac pacemaker is present) * Patients with any cardiopulmonary symptoms of unknown cause (e.g. shortness of breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (EKG) to rule out QTc prolongation; the patient may be referred to a cardiologist at the discretion of the principal investigator; patients with underlying cardiopulmonary dysfunction should be excluded from the study * Patients must have Zubrod performance status of 0-2 * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years * Collection and submission of pre-treatment cytogenetic specimens must be completed within 28 days prior to registration on S0805 * Collection and submission of pretreatment marrow and/or peripheral blood specimens for cellular and molecular studies, including verification of BCR/ABL status must be completed within 28 days prior to registration * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Patients must not have prior history of known type I hypersensitivity or anaphylactic reactions to doxorubicin * Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base * MAINTENANCE/INTENSIFICATION: * Patient must have achieved CR or CRi within 2 courses of Induction/Consolidation Chemotherapy; patient must remain in CR or CRi until beginning Maintenance Chemotherapy and this must be re-documented by bone marrow and peripheral blood examination within 28 days prior to registration to Step 2 * All treatment related toxicities must have resolved to =\< grade 2 * Patients must not have received allogeneic stem cell transplant * TRANSPLANT REGISTRATION: * Patients must have an available completely matched sibling donor or a 10/10 matched non-sibling donor * Patients must have allogeneic stem cell transplant arranged prior to registration to Step 3 * Patients must have documented CR or CRi within 14 days prior to registration to Step 3 * Patients must not be HIV + (human immunodeficiency virus); a negative HIV test must be obtained within 14 days prior to registration * POST TRANSPLANT/POST-MAINTENANCE SINGLE-AGENT DASATINIB THERAPY: * Patients must have reached day 100 post transplant or must have completed protocol maintenance/intensification (or must have been approved by the Study Chair after early removal from maintenance/intensification) * Patients must be in CR or CRi based on bone marrow and peripheral blood examination within 28 days prior to registration to Step 4 * Patients must have recovered to =\< grade 2 from all treatment related toxicity

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia adult acute lymphoblastic leukemia B-cell adult acute lymphocytic leukemia B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) Burkitt lymphoma leukemia, acute lymphocytic, susceptibility to, 1 Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma T-cell adult acute lymphocytic leukemia

As listed by the trial registrant

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

Acute lymphoblastic leukemia Adult B acute lymphoblastic leukemia Adult B acute lymphoblastic leukemia with T(9;22)(Q34.1;Q11.2); BCR-ABL1 Adult L1 acute lymphoblastic leukemia Adult L2 acute lymphoblastic leukemia Adult T acute lymphoblastic leukemia Recurrent adult acute lymphoblastic leukemia

Contacts and locations

Locations

AMG Libertyville - Oncology

Libertyville, Illinois, 60048, United States
AdventHealth Orlando

Orlando, Florida, 32803, United States
American Fork Hospital / Huntsman Intermountain Cancer Center

American Fork, Utah, 84003, United States
Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States
Associates In Womens Health

Wichita, Kansas, 67208, United States
Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States
Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States
Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, 57117-5045, United States
Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States
Baylor University Medical Center

Dallas, Texas, 75246, United States
Benefis Sletten Cancer Institute

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

Billings, Montana, 59101, United States
Blanchard Valley Hospital

Findlay, Ohio, 45840, United States
Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States
Bronson Battle Creek

Battle Creek, Michigan, 49017, United States
Cancer Care Center at Island Hospital

Anacortes, Washington, 98221, United States
Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States
Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado

El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas - McPherson

McPherson, Kansas, 67460, United States
Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons

Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt

Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina

Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States
Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States
Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman

Kingman, Kansas, 67068, United States
Cancer Center of Kansas-Liberal

Liberal, Kansas, 67905, United States
Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States
Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, 49503, United States
Case Western Reserve University

Cleveland, Ohio, 44106, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center

Wilmington, Ohio, 45177, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States
Dayton NCI Community Oncology Research Program

Dayton, Ohio, 45459, United States
DuPage Medical Group-Ogden

Naperville, Illinois, 60563, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Evergreen Hematology and Oncology PS

Spokane, Washington, 99218, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, Indiana, 46845, United States
Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, 46107, United States
Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States
Glacier Oncology PLLC

Kalispell, Montana, 59901, United States
Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406, United States
Grandview Hospital

Dayton, Ohio, 45405, United States
Great Falls Clinic

Great Falls, Montana, 59405, United States
Greene Memorial Hospital

Xenia, Ohio, 45385, United States
Harborview Medical Center

Seattle, Washington, 98104, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo

Poulsbo, Washington, 98370, United States
HaysMed

Hays, Kansas, 67601, United States
Hematology Oncology Associates of Illinois - Skokie

Skokie, Illinois, 60076, United States
Hematology Oncology Associates of Illinois-Highland Park

Highland Park, Illinois, 60035, United States
Hematology and Oncology Associates

Chicago, Illinois, 60611, United States
Hematology/Oncology Clinic PLLC

Baton Rouge, Louisiana, 70809, United States
Highline Medical Center-Main Campus

Burien, Washington, 98166, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
Hutchinson Regional Medical Center

Hutchinson, Kansas, 67502, United States
Illinois Cancer Specialists-Niles

Niles, Illinois, 60714, United States
Intermountain Medical Center

Murray, Utah, 84107, United States
Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States
Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States
Kaiser Permanente Washington

Seattle, Washington, 98112, United States
Kettering Medical Center

Kettering, Ohio, 45429, United States
LDS Hospital

Salt Lake City, Utah, 84143, United States
LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103, United States
Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States
Lewistown Hospital

Lewistown, Pennsylvania, 17044, United States
Logan Health Medical Center

Kalispell, Montana, 59901, United States
Logan Regional Hospital

Logan, Utah, 84321, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
MacNeal Hospital and Cancer Center

Berwyn, Illinois, 60402, United States
Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States
McKay-Dee Hospital Center

Ogden, Utah, 84403, United States
Medical College of Wisconsin

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

Charleston, South Carolina, 29425, United States
Mercy Hospital Pittsburg

Pittsburg, Kansas, 66762, United States
Mercy Medical Center-Sioux City

Sioux City, Iowa, 51102, United States
Miami Valley Hospital

Dayton, Ohio, 45409, United States
Miami Valley Hospital North

Dayton, Ohio, 45415, United States
Minor and James Medical PLLC

Seattle, Washington, 98104, United States
Montana Cancer Consortium NCORP

Billings, Montana, 59102, United States
Montana Cancer Specialists

Missoula, Montana, 59802, United States
Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States
Montefiore Medical Center-Weiler Hospital

The Bronx, New York, 10461, United States
Mount Nittany Medical Center

State College, Pennsylvania, 16803, United States
Munson Medical Center

Traverse City, Michigan, 49684, United States
Northwestern University

Chicago, Illinois, 60611, United States
PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225, United States
PeaceHealth United General Medical Center

Sedro-Woolley, Washington, 98284, United States
Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States
Presence Saint Mary's Hospital

Kankakee, Illinois, 60901, United States
Reid Health

Richmond, Indiana, 47374, United States
Rocky Mountain Oncology

Casper, Wyoming, 82609, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
SSM Health Saint Louis University Hospital

St Louis, Missouri, 63104, United States
Saint George Regional Medical Center

St. George, Utah, 84770, United States
Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States
Saint Joseph Medical Center Hematology and Oncology - Silverdale

Silverdale, Washington, 98383, United States
Saint Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States
Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802, United States
Saint Peter's Community Hospital

Helena, Montana, 59601, United States
Saint Rita's Medical Center

Lima, Ohio, 45801, United States
Saint Vincent Frontier Cancer Center

Billings, Montana, 59102, United States
Saint Vincent Healthcare

Billings, Montana, 59101, United States
Salina Regional Health Center

Salina, Kansas, 67401, United States
Sandra L Maxwell Cancer Center

Cedar City, Utah, 84720, United States
Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States
Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States
Southwest Medical Center

Liberal, Kansas, 67901, United States
Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, 49307, United States
Springfield Memorial Hospital

Springfield, Illinois, 62781, United States
Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States
Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026, United States
Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States
Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States
The Jewish Hospital

Cincinnati, Ohio, 45236, United States
The University of Kansas Cancer Center-South

Kansas City, Missouri, 64131, United States
Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States
Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444, United States
Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States
UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
UT MD Anderson Cancer Center

Houston, Texas, 77030, United States
University Health Truman Medical Center

Kansas City, Missouri, 64108, United States
University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States
University of Kansas Cancer Center-West

Kansas City, Kansas, 66112, United States
University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States
University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Michigan Health - West

Wyoming, Michigan, 49519, United States
University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States
University of Rochester

Rochester, New York, 14642, United States
University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States
Upper Valley Medical Center

Troy, Ohio, 45373, United States
Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, 84106, United States
Utah Valley Regional Medical Center

Provo, Utah, 84604, United States
Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Wayne Hospital

Greenville, Ohio, 45331, United States
Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Welch Cancer Center

Sheridan, Wyoming, 82801, United States
Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801, United States
Wesley Medical Center

Wichita, Kansas, 67214, United States
West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States
Wichita NCI Community Oncology Research Program

Wichita, Kansas, 67214, United States

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