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First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Ph-Positive ALL (ALL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01004497
First Posted: October 30, 2009
Last Update Posted: May 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seok Lee, The Catholic University of Korea
  Purpose
The main aim of the present study is to evaluate the clinical efficacy of first-line dasatinib plus conventional chemotherapy for newly diagnosed Ph-positive acute lymphoblastic leukemia. In this study, the investigators will analyze the clinical outcomes for entire patient population as well as those for transplants, respectively. In addition, the results of this study will be compared to those of the investigators current study (imatinib plus conventional chemotherapy). The safety of this treatment will also be studied.

Condition Intervention Phase
Acute Lymphoblastic Leukemia Drug: Dasatinib Drug: Cyclophosphamide Drug: Vincristine Drug: Daunorubicin Drug: Dexamethasone Drug: Cytarabine Drug: Mitoxantrone Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter Study of First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Seok Lee, The Catholic University of Korea:

Primary Outcome Measures:
  • To determine the clinical efficacy of dasatinib plus conventional chemotherapy for newly diagnosed Ph-positive ALL in terms of major molecular response rate [ Time Frame: by the second 4-week dasatinib therapy ]

Secondary Outcome Measures:
  • To evaluate the long-term clinical outcomes (including transplant outcomes) in terms of treatment toxicity, relapse, disease-free survival, and overall survival [ Time Frame: at 2 years after transplantation (for all transplants); at 2 years after starting dasatinib maintenance (for all non-transplants) ]

Enrollment: 51
Study Start Date: March 2010
Study Completion Date: April 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified Hyper-CVAD + Dasatinib
Dasatinib: 100 mg once daily, PO, for 4 weeks Cyclophosphamide: 300 mg/m2, IV, every 12 hours, days 1~3 Vincristine: 1.4 mg/m2/day (maximum 2 mg/day), IV, days 4 & 11 Daunorubicin: 45 mg/m2/day, IV, days 4 & 11 Dexamethasone: 40 mg/day, IV, days 1~4 & days 11~14 Cytarabine: 2 g/m2, IV, every 12 hours, days 1~5 Mitoxantrone: 12 mg/m2/day, IV, days 1~2
Drug: Dasatinib
After the completion of each induction and consolidation chemotherapy with recovery of leukocyte and platelet counts, dasatinib will be given as an alternative manner: 100 mg by mouth once daily for 4 weeks
Other Name: Sprycel
Drug: Cyclophosphamide
300 mg/m2, IV for 2 hours, every 12 hours x 6 doses, days 1-3
Other Name: Endoxan
Drug: Vincristine
1.4 mg/m2/day (maximum 2 mg/day), IV for 30 minutes, days 4 & 11
Other Name: Vincristine sulfate
Drug: Daunorubicin
45 mg/m2/day, IV for 1 hour, days 4 & 11
Other Name: Cerubidine
Drug: Dexamethasone
40 mg/day, IV push, days 1-4 & days 11-14
Other Name: Dexamethasone disodium phosphate
Drug: Cytarabine
2 g/m2, IV for 3 hours, every 12 hours x 10 doses, days 1-5
Other Name: Cytosar U
Drug: Mitoxantrone
12 mg/m2/day, IV for 30 minutes, days 1-2
Other Name: Mitrone

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed acute lymphoblastic or biphenotypic leukemia (karyotypic or molecular evidence of Ph)
  • Ages of 15-65 years
  • Eastern Cooperative Oncology Group performance status of 0-2
  • Adequate renal (serum creatinine less than 2 mg/dl, unless considered due to leukemia) and hepatic (serum bilirubin less than 3 mg/dl, unless considered due to leukemia) functions
  • Adequate cardiac status (New York Heart Association Class less than or equal to 2)
  • Signed informed consent

Exclusion Criteria:

  • Pregnant and lactating women will not be eligible. Women of childbearing potential should have a negative pregnancy test prior to entering on the study.
  • Active cardiac dysfunction (New York Heart Association Class more than or equal to 3), uncontrolled angina, myocardial infarction (within 6 months), congenital long QT syndrome, any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia or ventricular fibrillation), or prolonged QTc interval on pre-entry electrocardiogram (more than 470 msec)
  • Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia
  • Patients with severe medical conditions that in the view of the investigator prohibits participation in the study
  • Treatment with any other investigational antileukemic agents in the last 30 days before study entry
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004497


Locations
Korea, Republic of
Chonbuk National University Hospital
Chonju, Chonbuk, Korea, Republic of, 561-712
Soonchunhyang University Bucheon Hospital
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
National Cancer Center
Goyang, Gyeonggi-do, Korea, Republic of, 410-769
Chonnam National University Hwasun Hospital
Hwasun, Jeonnam, Korea, Republic of, 519-809
St. Vincent's Hospital, The Catholic University of Korea
Suwon, Kyonggi-do, Korea, Republic of, 442-723
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
Catholic BMT Center, Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 137-701
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Seok Lee, M.D. Catholic BMT Center, Seoul St. Mary's Hospital, The Catholic University of Korea
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seok Lee, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01004497     History of Changes
Other Study ID Numbers: KC09MIMS0255
First Submitted: October 29, 2009
First Posted: October 30, 2009
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Seok Lee, The Catholic University of Korea:
Acute lymphoblastic leukemia, adult, dasatinib

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Cyclophosphamide
Cytarabine
Vincristine
Dasatinib
Mitoxantrone
Daunorubicin
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors