Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038610
First received: June 3, 2002
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

The goal of this clinical research study is to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of this treatment will also be studied.


Condition Intervention Phase
Leukemia, Lymphocytic, Acute, L2
Drug: Imatinib
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Dexamethasone
Drug: Methotrexate
Drug: Cytarabine
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: Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Patients with Event-free survival after hyper-CVAD plus imatinib mesylate [ Time Frame: Baseline to 2 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: March 2001
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyper-CVAD + Imatinib
Imatinib 600 mg by mouth. Cyclophosphamide 300 mg/m2. Doxorubicin 50 mg/m2. Vincristine 2 mg. Dexamethasone 40 mg. Methotrexate 200 mg/m2. Cytarabine 3 gm/m2.
Drug: Imatinib
Imatinib 600mg PO
Other Name: Gleevec
Drug: Cyclophosphamide
Cyclophosphamide 300mg/m2
Other Names:
  • Cytoxan®,
  • Neosar®
Drug: Doxorubicin
Doxorubicin 50mg/m2
Other Names:
  • Adriamycin ®,
  • Rubex ®
Drug: Vincristine
Vincristine 2mg
Other Name: Oncovin ®, Vincasar Pfs ®
Drug: Dexamethasone
Dexamethasone 40mg
Other Name: Decadron
Drug: Methotrexate
Methotrexate 200mg/m2
Other Name: Rheumatrex®, TrexallTM
Drug: Cytarabine
Cytarabine 3gm/m2
Other Names:
  • Ara-C
  • Cytosar-U®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of previously untreated Ph-positive ALL or previously treated in CR after 1-2 courses of therapy or failure after one course of induction chemotherapy without imatinib mesylate.
  2. Age > or = 15 years. Those < 15 years of age will be treated under compassionate IND.
  3. Zubrod performance status < or = 2 (ECOG Scale, Appendix A).
  4. Adequate liver function (bilirubin < or = to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine < or = to 3.0 mg/dl, unless considered due to tumor).
  5. Adequate cardiac function as assessed clinically by physical examination.
  6. Signed informed consent.

Exclusion Criteria:

  1. Active serious infection not controlled by oral or intravenous antibiotics.
  2. Treatment with 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 life-threatening.
  3. Active secondary malignancy other than skin cancer (e.g. basal cell carcinoma or squamous cell carcinoma) than in investigator's opinion will shorten survival to less than 1 year.
  4. History of Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
  5. Prior history of treatment with imatinib mesylate.
  6. Pregnancy or lactating in women of childbearing potential.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038610

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Naval Daver, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038610     History of Changes
Other Study ID Numbers: ID01-006
Study First Received: June 3, 2002
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

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
Imatinib
Dexamethasone
Doxorubicin
Vincristine
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
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 April 22, 2014