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Hyper-CVAD Plus Dasatinib in Philadelphia/BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)

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ClinicalTrials.gov Identifier: NCT00390793
Recruitment Status : Active, not recruiting
First Posted : October 20, 2006
Last Update Posted : March 28, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this clinical research study is to find out if intensive chemotherapy combined with dasatinib, followed by maintenance therapy, can help to control ALL with the Ph chromosome and/or BCR-ABL. The safety of this treatment will also be studied.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Leukemia Drug: Cyclophosphamide Drug: Vincristine Drug: Doxorubicin Drug: Dexamethasone Drug: Dasatinib Drug: Methotrexate Drug: Ara-C Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Combination of Hyper-CVAD and Dasatinib in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)
Actual Study Start Date : September 2006
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Arms and Interventions

Arm Intervention/treatment
Experimental: Hyper-CVAD + Dasatinib
Odd-numbered courses (1, 3, 5, and 7), Cyclophosphamide intravenous (IV) Days 1-3, every 12 hours for 6 doses with MESNA CVC over 24 hours until 12 hours after last dose cyclophosphamide; Vincristine IV Days 4 and 11, over 30 minutes during hyper-CVAD therapy; Doxorubicin CVC Day 4 over 24-48 hours after last dose of Cyclophosphamide; Dexamethasone Days 1-4 & Days 11-14 PO or IV over 30 minutes during hyper-CVAD therapy.
Drug: Cyclophosphamide
300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2 & 3
Other Name: Cytoxan
Drug: Vincristine
2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days
Other Name: Vincasar
Drug: Doxorubicin
50 mg/m^2 IV over 24 hours on day 4
Other Name: Adriamycin
Drug: Dexamethasone
40 mg IV or by mouth days 1-4 +/- 2 days and days 11-14 +/- 2 days
Other Name: Decadron
Drug: Dasatinib
100 mg by mouth (PO) daily on days 1-14; 70 mg PO daily continuously for Course 2 - 8.
Other Name: Sprycel
Drug: Ara-C
3 g/m^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3.
Other Names:
  • Cytarabine
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrochloride
  • Ara-con
Experimental: Methotrexate + Ara-C
Even-numbered courses (2, 4, 6, and 8), Methotrexate IV Day 1; Ara-C IV Days 2 and 3 (over 2 hours every 12 hours for total of 4 doses each time)
Drug: Dasatinib
100 mg by mouth (PO) daily on days 1-14; 70 mg PO daily continuously for Course 2 - 8.
Other Name: Sprycel
Drug: Methotrexate
200 mg/m^2 over 2 hours followed by 800 mg/m^2 over 22 hours on day 1.
Drug: Ara-C
3 g/m^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3.
Other Names:
  • Cytarabine
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrochloride
  • Ara-con

Outcome Measures

Primary Outcome Measures :
  1. Event-Free Survival (CR rates and disease-free survivals) [ Time Frame: 2 Years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of one of the following: Previously untreated Ph-positive ALL [either t(9;22) and/or bcr-abl positive] (includes patients initiated on first course of hyper-CVAD before cytogenetics known) These groups will be analyzed separately. After 1-2 courses of chemotherapy with or without imatinib mesylate (Gleevec) · If they achieved CR, they are assessable only for event-free and overall survival, or · If they failed to achieve CR, they are assessable for CR, event-free, and overall survival. Patients with relapsed Ph-positive ALL or lymphoid blast phase of CML.
  2. Age greater than or equal to 18 years
  3. ECOG performance status less than or equal to 2
  4. Adequate liver function (bilirubin less than or equal to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine less than or equal to 3.0 mg/dl, unless considered due to tumor)
  5. Adequate cardiac function as assessed clinically.
  6. Signed informed consent

Exclusion Criteria:

  1. Active serious infection not controlled by oral or intravenous antibiotics
  2. Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator
  3. Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
  4. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria. Uncontrolled angina, or MI within 6 months. Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes). Prolonged QTc interval on pre-entry electrocardiogram (> 470 msec). Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes (unless these can be changed to acceptable alternatives)
  5. Prior history of treatment with dasatinib
  6. Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
  7. History of significant bleeding disorder unrelated to cancer, including: · Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) · Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
  8. Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia
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): NCT00390793

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bristol-Myers Squibb
Principal Investigator: Farhad Ravandi-Kashani, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00390793     History of Changes
Other Study ID Numbers: 2006-0478
NCI-2010-00518 ( Registry Identifier: NCI CTRP )
First Posted: October 20, 2006    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Acute Lymphocytic Leukemia
Philadelphia-Positive ALL
BCR-ABL Positive ALL

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents