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Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia - Article


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Imatinib

Gleevec; imatinib mesylate



Clinical Trial: Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

This study is currently recruiting patients.

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center

Purpose

The goal of this clinical research study if to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 1 year can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of this treatment will also be studied.

Condition Treatment or Intervention Phase
Leukemia, Lymphocytic, Acute, L2
 Drug: imatinib mesylate
 Drug: cyclophosphamide
 Drug: MESNA
 Drug: doxorubicin
 Drug: vincristine
 Drug: decadron
 Drug: GCSF
 Drug: methotrexate
 Drug: ara-C
 Drug: solumedrol
 Drug: citrovorum
 Drug: prednisone
Phase II

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title: Phase II Study of Hyper-CVAD plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia

Further Study Details: 

Expected Total Enrollment:  40

Study start: March 2001

Long-term disease-free survival continues to be poor for the Philadelphia-positive ALL group with 2-year rates less than 10%. Imatinib mesylate is a oral tyrosine kinase inhibitor targeting the bcr-abl fusion gene protein, and has demonstrated anti-leukemia activity as a single agent in CML and Philadelphia-positive ALL. Therefore,the combination of imatinib mesylate with the active hyper-CVAD program will be studied. The objective of the clinical trial is to determine the clinical efficacy (overall response rate, even-free survival, and survival) and safety of the intensive short-term chemotherapy regimen (hyper-CVAD program) given in combination with imatinib mesylate for Philadelphia-positive ALL.

Eligibility

Ages Eligible for Study:  15 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion:

  • Diagnosis of one of the following: (1) Previously untreated Ph-positive ALL [either t(9;22) or bcr-abl positive] (includes patients initiated on first course of hyper-CVAD before cytogenetics known), or (2) Previously treated Ph-ALL (a) Failure to one course of chemotherapy (b) In CR after 1-2 courses of chemotherapy without imatinib mesylate (Gleevec); (i) If they achieved CR, they are assessable only for event-free and overall survival, or (ii) If they failed to achieve CR, they are assessable for CR, event-free, and overall survival. These groups will be analyzed separately.
  • Age >/= 15 years; Those < 15 years of age will be treated under compassionate IND;
  • Zubrod performance status </= 2 (ECOG Scale);
  • Adequate liver function (bilirubin </= 3.0 mg/dl, unless considered due to tumor) and renal function (creatinine </= 3.0 mg/dl, unless considered due to tumor);
  • Adequate cardiac function as assessed by physical examination;
  • Signed informed consent indicating that patient are aware of the investigational nature of the study in keeping with the policies of M.D. Anderson Cancer Center. The only acceptable consent form is the one attached to the end of the protocol.

Exclusion:

  • Active serious infection not controlled by oral or intravenous antibiotics;
  • Treatment with any investigational antileukemic agent 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;
  • 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;
  • History of Grade III/IV cardiac problems as defined by the New York Heart Association Criteria;
  • Prior history of treatment with imatinib mesylate (Gleevec);
  • Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering 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.

Location and Contact Information

Deborah A Thomas, MD      713-745-4616    debthomas@mdanderson.org

Texas
      MD Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting
Deborah A Thomas, MD  713-745-4616    debthomas@mdanderson.org 
Deborah A Thomas, MD,  Principal Investigator
Jorge E Cortes, MD,  Sub-Investigator

More Information

Study ID Numbers:  ID01-006
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  June 3, 2002
ClinicalTrials.gov Identifier:  NCT00038610
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: September 6, 2005
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