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Hyper-CVAD Plus Dasatinib in Philadelphia/BCR-ABL Positive ALL
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, February 2009
First Received: October 18, 2006   Last Updated: February 18, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
Bristol-Myers Squibb
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00390793
  Purpose

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 Intervention Phase
Acute Lymphoblastic Leukemia
Leukemia
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Doxorubicin
Drug: Dexamethasone
Drug: Dasatinib
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Dexamethasone Cyclophosphamide Vincristine Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Myocet Dasatinib Dexamethasone Sodium Phosphate Vincristine sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To evaluate the clinical efficacy (event-free survival) of an intensive short-term chemotherapy regimen (Hyper-CVAD) given in combination with the tyrosine kinase inhibitor dasatinib for (h)-positive and/or BCR-ABL-positive ALL. [ Time Frame: February 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate other clinical efficacy and safety of an intensive short-term chemotherapy regimen (Hyper-CVAD) given in combination with the tyrosine kinase inhibitor dasatinib for (Ph)-positive and/or BCR-ABL-positive ALL. [ Time Frame: February 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: September 2006
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Hyper-CVAD + Dasatinib
Drug: Cyclophosphamide
300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2 & 3
Drug: Vincristine
2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days
Drug: Doxorubicin
50 mg/m2 IV over 24 hours on day 4
Drug: Dexamethasone
40 mg IV or by mouth days 1-4 +/- 2 days and days 11-14 +/- 2 days
Drug: Dasatinib
50 mg by mouth twice daily days 1-14

  Show Detailed Description

  Eligibility

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

Inclusion:

  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:

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390793

Contacts
Contact: Farhad Ravandi-Kashani, M.D. 713-745-0394 fravandi@mdanderson.org

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

Additional Information:
No publications provided

Responsible Party: The University of Texas M. D. Anderson Cancer Center ( Farhad Ravandi-Kashani, M.D./ Associate Professor )
Study ID Numbers: 2006-0478
Study First Received: October 18, 2006
Last Updated: February 18, 2009
ClinicalTrials.gov Identifier: NCT00390793     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Acute Lymphocytic Leukemia
Leukemia
ALL
Philadelphia-Positive ALL
BCR-ABL Positive ALL
Dasatinib
Hyper-CVAD
Cyclophosphamide
Cytoxan
Vincristine
Vincasar
Doxorubicin
Adriamycin
Dexamethasone
Decadron
Dasatinib
Sprycel

Study placed in the following topic categories:
Anti-Inflammatory Agents
Dexamethasone
Leukemia, Lymphoid
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Cyclophosphamide
Protein Kinase Inhibitors
Hormones
Anti-Bacterial Agents
Leukemia
Dasatinib
Hyperkinesis
Lymphoma
Alkylating Agents
Dexamethasone acetate
Acute Lymphoblastic Leukemia
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Antineoplastic Agents, Hormonal
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Glucocorticoids
Doxorubicin
Lymphatic Diseases
Tubulin Modulators
Antineoplastic Agents, Alkylating
Peripheral Nervous System Agents

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Leukemia, Lymphoid
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Cyclophosphamide
Antibiotics, Antineoplastic
Protein Kinase Inhibitors
Hormones
Leukemia
Dasatinib
Therapeutic Uses
Alkylating Agents
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Gastrointestinal Agents
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Glucocorticoids
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 07, 2009