Hyper-CVAD Plus Dasatinib in Philadelphia/BCR-ABL Positive ALL

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00390793
First received: October 18, 2006
Last updated: March 4, 2014
Last verified: March 2014
  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 Acute Lymphoblastic Leukemia (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
Drug: Methotrexate
Drug: Ara-C
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Event-Free Survival (CR rates and disease-free survivals) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: September 2006
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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

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
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: NCT00390793

Locations
United States, Texas
UT MD Anderson Cancer Center
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 by M.D. Anderson Cancer Center

Additional 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
Study First Received: October 18, 2006
Last Updated: March 4, 2014
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
Sprycel

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Methotrexate
Dexamethasone
Doxorubicin
Vincristine
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Dasatinib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on July 22, 2014