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Study Summary
No. 2007-0772:.......Blood And Marrow Transplantation; Leukemia......Marina Konopleva......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2007-0772
Study Title:G-CSF and Plerixafor with Busulfan and Fludarabine for Allogeneic Stem Cell Transplantation for Myeloid Leukemias
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Physician New Patient Referral
Name:Marina KonoplevaPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-1628
Contact us about clinical trials
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General Information
Disease Group:Blood And Marrow Transplantation
Leukemia
Supported By:Genzyme
Phase of Study:Phase I/Phase IIReturn
Visit:
Up to daily for the first 100 days, every 3 months for one year, yearly
thereafter x 5 years.
Treatment
Agents:
ATG
Busulfan
Filgrastim
Fludarabine
G-CSF
Plerixafor
Home Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
28 days
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
Primary Objective:
1. To determine the safety of Plerixafor and Filgrastim (G-CSF) in combination with busulfan, fludarabine and allogeneic hematpoietic transplantation for treatment of advanced myeloid leukemias.

2. Determine biologic effects of Plerixafor and G-CSF on leukemia cells.

3. To determine if the combination of Plerixafor and G-CSF with busulfan, fludarabine will improve progression free survival post allogeneic stem cell transplantation from an HLA-compatible donor compared to historical controls receiving busulfan-fludarabine alone.

Secondary Objectives:

1. To determine the time to engraftment, the rate and severity of GVHD, and immune reconstitution.
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Study Status Information
Study Activation / Registration Date:01/02/2009
IRB Review and Approval Date:04/04/2008
Study Type:Phase I
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients age >/=18 to </= 65 years.

2) Diagnosis of AML in first or greater remission, first or subsequent relapse, or primary induction failure; MDS with intermediate or high risk International Prognostic Scoring System (IPSS) score having failed to respond or recurred after chemotherapy; in remission or having active disease after treatment; AML arising from MDS; or CML which has failed to respond to imatinib or other tyrosine kinase inhibitor and has had >5% blasts in the blood or bone marrow. Patients receiving second transplants after relapse are considered in the relapse group.

3) WBC </= 20 x 10^9/l.

4) Patients should have a histocompatible, related or unrelated volunteer donor available. A histocompatible donor is defined as HLA matched related donor or an unrelated donor matched for HLA- A, B, C, and DR antigens by high-resolution DNA techniques.

5) Zubrod performance status 0 or 1, or Karnofsky performance status 90-100%.

6) Left ventricular ejection fraction >/= 45 %. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.

7) No symptomatic pulmonary disease. Forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC) and diffusion capacity of carbon monoxide (DLCO) >/= 50 % of expected, corrected for hemoglobin.

8) Serum creatinine </=1.5 mg/dl.

9) Serum glutamic pyruvic transaminase (SGPT) </= 200 IU/ml unless related to the malignancy.

10) Total serum bilirubin </=1.5 mg/dl (unless Gilbert's syndrome) and alkaline phosphatase </=2.5 times laboratory standard upper limit of normal (ULN).

11) Patient or patient's legal representative able to sign informed consent.

Exclusion Criteria:1) History of HIV positive.

2) Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.

3) Pleural/pericardial effusion or ascites estimated >/= 1 liter.

4) Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.

5) History of acute hepatitis, chronic active hepatitis or cirrhosis.

6) Patients with class 3 or 4 angina (NYHA criteria).

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Links
Registration Number: NCT00822770
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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