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Gleevec/Low-Dose Ara-C Study for Elderly Patients With AML and Myelodysplastic Syndromes

Primary Purpose

Leukemia, Myeloid, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gleevec
Ara-C
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid focused on measuring AML, MDS, Gleevec, Ara-C, C-Kit Positive Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndromes

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are not candidates for intensive chemotherapy with any of the following diagnosis: 1. AML or MDS (with >/=5% blasts) age >/= 65 years old (or age >/= 60 if high-risk cytogenetics), or 2. AML or MDS (RAEB or RAEBT) of any cytogenetic group age 60 or older with minimally treated disease who have relapsed disease or are refractory to therapy and not likely to require cytoreductive therapy within one month, and, or 3. CMML.
  • Patients with WHO performance status of 0 to 2
  • Patients must have recovered from prior cytotoxic chemotherapy; treatment with hydrea is allowed up to 24 hours prior to day 1 of study drug administration
  • Written informed consent obtained according to local guidelines
  • Patients must have a serum creatinine of </= 1.5 x ULN, SGPT </= 3 x ULN and total bilirubin </= 2.0 x ULN.
  • Patients with >/= 20% blasts positive for c-kit (CD117) (except for CMML)
  • Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of childbearing potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug.

Exclusion Criteria:

  • Patients with uncontrolled active infection
  • Patients with NYHA class III or IV
  • Women who are pregnant
  • Women who are breast feeding

Sites / Locations

  • The University of Texas M.D. Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gleevec + Low-Dose Ara-C

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of a combination of imatinib and low dose ara-C in elderly or high-risk patients with AML and MDS, as measured by the rate of early mortality or progression.

Secondary Outcome Measures

Rate of overall response, including CRp and PR.
To determine the safety profile of this combination.
To determine the impact on long-term survival of this therapy.
To determine the duration of responses obtained with this therapy.
To determine the impact of this therapy in cognitive function.
To determine the effect of this approach in quality of life of this patient population.
To determine the overall costs (health economic analysis) associated with this combination therapy.

Full Information

First Posted
March 23, 2007
Last Updated
July 31, 2012
Sponsor
M.D. Anderson Cancer Center
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00451997
Brief Title
Gleevec/Low-Dose Ara-C Study for Elderly Patients With AML and Myelodysplastic Syndromes
Official Title
Phase II Trial of Gleevec and Low-Dose Ara-C for Elderly Patients With C-Kit Positive Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical research study is to learn if the combination of Gleevec (imatinib mesylate) and low doses of Cytarabine (ara-C) may help to control leukemia while causing fewer side effects than standard high dose chemotherapy.
Detailed Description
Imatinib mesylate is a drug that blocks a certain protein. This protein is thought to be important in the growth of leukemia cells. Ara-C is a chemotherapy drug that has been used for many years to treat AML and MDS. Imatinib mesylate (Gleevec) is a protein-tyrosine kinase inhibitor that inhibits the Bcr-Abl tyrosine kinase, as well as the receptor tyrosine kinases for platelet- derived growth factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events. c-Kit is expressed in over 90% of patients with AML. The treatment of AML for patients age 65 or older with AML or high-risk MDS (age ³ 60 if high-risk cytogenetics) have a poor prognosis with induction chemotherapy. Response rate is no more than 45% with an induction mortality of at least 25%, and 1-year survival no better than 20%. Indeed, most patients in these age groups are not even offered therapy and are managed with supportive care only. Thus, new therapies that are better tolerated are needed. Imatinib alone can induce response in nearly 20% of patients, and there is synergy with low concentrations of ara-C. In this study we plan to investigate the combination of imatinib and low-dose ara-C.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Myelodysplastic Syndromes
Keywords
AML, MDS, Gleevec, Ara-C, C-Kit Positive Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gleevec + Low-Dose Ara-C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gleevec
Other Intervention Name(s)
Imatinib Mesylate, STI-571, Imatinib, NSC-716051
Intervention Description
600 mg (capsules) by mouth once daily
Intervention Type
Drug
Intervention Name(s)
Ara-C
Other Intervention Name(s)
Cytarabine, Cytosar-U®, DepoCyt, Cytosine arabinosine hydrochloride, Arabinosylcytosine
Intervention Description
10 mg as an injection under the skin daily for 21 days of every 28 day cycle
Primary Outcome Measure Information:
Title
Efficacy of a combination of imatinib and low dose ara-C in elderly or high-risk patients with AML and MDS, as measured by the rate of early mortality or progression.
Time Frame
April 2007
Secondary Outcome Measure Information:
Title
Rate of overall response, including CRp and PR.
Time Frame
April 2007
Title
To determine the safety profile of this combination.
Time Frame
April 2007
Title
To determine the impact on long-term survival of this therapy.
Time Frame
April 2007
Title
To determine the duration of responses obtained with this therapy.
Time Frame
April 2007
Title
To determine the impact of this therapy in cognitive function.
Time Frame
April 2007
Title
To determine the effect of this approach in quality of life of this patient population.
Time Frame
April 2007
Title
To determine the overall costs (health economic analysis) associated with this combination therapy.
Time Frame
April 2007

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are not candidates for intensive chemotherapy with any of the following diagnosis: 1. AML or MDS (with >/=5% blasts) age >/= 65 years old (or age >/= 60 if high-risk cytogenetics), or 2. AML or MDS (RAEB or RAEBT) of any cytogenetic group age 60 or older with minimally treated disease who have relapsed disease or are refractory to therapy and not likely to require cytoreductive therapy within one month, and, or 3. CMML. Patients with WHO performance status of 0 to 2 Patients must have recovered from prior cytotoxic chemotherapy; treatment with hydrea is allowed up to 24 hours prior to day 1 of study drug administration Written informed consent obtained according to local guidelines Patients must have a serum creatinine of </= 1.5 x ULN, SGPT </= 3 x ULN and total bilirubin </= 2.0 x ULN. Patients with >/= 20% blasts positive for c-kit (CD117) (except for CMML) Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of childbearing potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug. Exclusion Criteria: Patients with uncontrolled active infection Patients with NYHA class III or IV Women who are pregnant Women who are breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge E Cortes, MD
Organizational Affiliation
The University of M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://mdanderson.org
Description
M.D. Anderson's website

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Gleevec/Low-Dose Ara-C Study for Elderly Patients With AML and Myelodysplastic Syndromes

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