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Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01256398
First received: December 7, 2010
Last updated: November 21, 2014
Last verified: July 2014
  Purpose

This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.


Condition Intervention Phase
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1
Untreated Adult Acute Lymphoblastic Leukemia
Biological: Alemtuzumab
Drug: Dasatinib
Drug: Daunorubicin Hydrochloride
Drug: Fludarabine Phosphate
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
Drug: Dexamethasone
Drug: Cyclophosphamide
Biological: Filgrastim
Biological: Pegfilgrastim
Drug: Methotrexate
Drug: Leucovorin Calcium
Drug: Melphalan
Drug: Tacrolimus
Drug: Etoposide Phosphate
Drug: Cytarabine
Drug: Mercaptopurine
Drug: Vincristine Sulfate
Other: Pharmacological Study
Other: Laboratory Biomarker Analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Dasatinib (Sprycel®) (NSC #732517) as Primary Therapy Followed by Transplantation for Adults ≥ 18 Years With Newly Diagnosed PH+ Acute Lymphoblastic Leukemia by CALGB, ECOG AND SWOG

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • DFS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.


Secondary Outcome Measures:
  • Probability of being BCR-ABL negative in the bone marrow and peripheral blood at the completion of the CNS prophylaxis course (restricted to those patients achieving a complete response [CR]) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Proportions will be estimated based on the combined and individual cohorts.

  • Feasibility of maintenance therapy in this patient population (restricted to those patients achieving a CR) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Proportions will be estimated based on the combined and individual cohorts.

  • OS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.

  • DFS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.

  • Response [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: December 2010
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemotherapy, transplant)
See Detailed Description
Biological: Alemtuzumab
Given IV
Other Names:
  • Campath
  • LDP-03
  • MabCampath
  • MoAb CD52
Drug: Dasatinib
Given PO
Other Names:
  • BMS-354825
  • Sprycel
Drug: Daunorubicin Hydrochloride
Given IV
Other Names:
  • DNM
  • DNR
  • DRB
Drug: Fludarabine Phosphate
Given IV
Other Names:
  • 2-F-ara-AMP
  • Beneflur
  • SH T 586
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo peripheral blood allogeneic HCT
Other Names:
  • HSC
  • HSCT
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo peripheral blood autologous HCT
Other Name: Autologous Stem Cell Transplantation
Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
Undergo peripheral blood autologous or allogeneic HCT
Other Names:
  • in vitro-treated PBPC transplantation
  • in vitro-treated peripheral blood progenitor cell transplantation
Drug: Dexamethasone
Given PO or IV
Other Name: DM
Drug: Cyclophosphamide
Given IV
Biological: Filgrastim
Given SC
Other Names:
  • G-CSF
  • Nivestim
  • r-metHuG-CSF
Biological: Pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • GCSF-SD01
  • Neulasta
Drug: Methotrexate
Given IT, IV, or PO
Drug: Leucovorin Calcium
Given IV or PO
Other Name: CF
Drug: Melphalan
Given IV
Other Name: Alkeran
Drug: Tacrolimus
Given IV or PO
Other Names:
  • Advagraf
  • FK 506
Drug: Etoposide Phosphate
Given IV
Other Names:
  • ETOP
  • Etopophos
Drug: Cytarabine
Given IV
Other Names:
  • CHX-3311
  • U-19920
Drug: Mercaptopurine
Given PO
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Other: Pharmacological Study
Correlative studies
Other Name: pharmacological studies
Other: Laboratory Biomarker Analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unequivocal histologic diagnosis of ALL
  • Detection of the t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics or BCR-ABL positive status by molecular analysis (Q-PCR or fluorescent in situ hybridization [FISH]) in a Cruise Lines International Association (CLIA)-approved laboratory
  • No prior therapy except up to one week of corticosteroids and/or hydroxyurea to enable time for the detection of t(9;22)(q34;q11) or BCR/ABL
  • Non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control and contraception should continue for three months after the last dose of dasatinib to allow complete clearance of drug and its principal metabolites from the body; in women of childbearing potential, a pregnancy test will be required at study entry
  • Left ventricular ejection fraction >= lower limit of institutional normal
  • No myocardial infarction within 6 months
  • No ventricular tachyarrhythmia within 6 months
  • No major conduction abnormality (unless a cardiac pacemaker is present)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256398

  Hide Study Locations
Locations
United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States, 80907
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States, 80220
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80907
Mercy Medical Center
Durango, Colorado, United States, 81301
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, United States, 80113
Swedish Medical Center
Englewood, Colorado, United States, 80113
Mountain Blue Cancer Care Center
Golden, Colorado, United States, 80401
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Breast Cancer Care Consultants
Greenwood Village, Colorado, United States, 80111
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States, 80228
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States, 80124
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, United States, 81008
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Regional Hematology and Oncology PA
Newark, Delaware, United States, 19713
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States, 19713
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States, 19713
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
Nanticoke Memorial Hospital
Seaford, Delaware, United States, 19973
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States, 19801
United States, Florida
Florida Hospital Orlando
Orlando, Florida, United States, 32803
United States, Illinois
University of Illinois
Chicago, Illinois, United States, 60612
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
Northwestern University
Chicago, Illinois, United States, 60611
Presence Saint Mary's Hospital
Kankakee, Illinois, United States, 60901
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States, 61107
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
United States, Indiana
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States, 66502
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wesley Medical Center
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Maine
Harold Alfond Center for Cancer Care
Augusta, Maine, United States, 04330
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
North Shore University Hospital
Manhasset, New York, United States, 11030
North Shore-LIJ Health System CCOP
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
North Shore-LIJ Health System/Center for Advanced Medicine
New Hyde Park, New York, United States, 11040
Weill Medical College of Cornell University
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Jewish Hospital
Cincinnati, Ohio, United States, 45236
United States, Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
United States, Wisconsin
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
United States, Wyoming
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, United States, 82001
Sponsors and Collaborators
Investigators
Principal Investigator: Meir Wetzler Alliance for Clinical Trials in Oncology
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01256398     History of Changes
Other Study ID Numbers: NCI-2011-02621, NCI-2011-02621, CDR0000690286, CALGB-10701, CALGB 10701/CTSU C10701, CALGB 10701/CTSU C10701, CALGB-10701, U10CA031946
Study First Received: December 7, 2010
Last Updated: November 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Dasatinib
Daunorubicin
Dexamethasone
Etoposide
Etoposide phosphate
Fludarabine
Fludarabine phosphate
Lenograstim
Levoleucovorin
Methotrexate
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Adjuvants, Immunologic
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antidotes
Antiemetics
Antimetabolites

ClinicalTrials.gov processed this record on November 25, 2014