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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seok Lee, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01004497
First received: October 29, 2009
Last updated: May 20, 2014
Last verified: May 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 51
Study Start Date: March 2010
Estimated Study Completion Date: September 2014
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

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
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
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: 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
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
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
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

No publications provided

Responsible Party: Seok Lee, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01004497     History of Changes
Other Study ID Numbers: KC09MIMS0255
Study First Received: October 29, 2009
Last Updated: May 20, 2014
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

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

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
BB 1101
Cyclophosphamide
Cytarabine
Dasatinib
Daunorubicin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Mitoxantrone
Vincristine
Alkylating Agents
Analgesics
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on October 20, 2014