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Study Summary
No. 2004-0190:.......Leukemia; Lymphoma; Myeloma......Partow Kebriaei......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2004-0190
Study Title:A Phase II study of high-dose intravenous busulfan plus melphalan with allogeneic or autologous marrow or peripheral blood progenitor cell transplantation for lymphoid malignancies or multiple myeloma.
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Physician New Patient Referral
Name:Partow KebriaeiPatients 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:713-745-0663
Contact us about clinical trials
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General Information
Disease Group:Leukemia
Lymphoma
Myeloma
Supported By:N/A
Phase of Study:Phase IIReturn
Visit:
Every 3 months during the first year if possible.
Treatment
Agents:
Busulfan
Melphalan
Home Care:IV fluids, etc. as determined by patient's clinical status.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
100 days post transplant, and will include inpatient and out patient care
during this time period.
Description/
Intervention:
The goal of this clinical research study is to learn if giving busulfan along
with melphalan, followed by allogeneic or autologous bone marrow (BMT) or
peripheral blood stem cell transplant (PBSCT) can safely help to control the
disease in patients with advanced hematologic cancer. The therapeutic component
of this study is the use of busulfan and melphalan, which are established
chemotherapy drugs for stem cell transplantation. The research aspect of this
protocol is the pharmacokinetic dosing and monitoring of Busulfan as explained
in the optional procedures section below.
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Study Objectives / Outcomes
1.1 To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration vs. time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in adult patients receiving autologous or allogeneic transplantation for lymphoid malignancies or myeloma.
1.2 To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this regimen.
1.3 To determine the disease-free and overall survival of patients receiving this preparative regimen.
1.4 To determine the treatment-related morbidity and mortality of this combination of drugs.
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Study Status Information
Study Activation / Registration Date:12/28/2004
IRB Review and Approval Date:11/03/2004
Study Type:Therapeutic
Recruitment Status:Closed
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 with lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or recurrent), or multiple myeloma (beyond first complete remission or unresponsive to therapy. Complete remission for multiple myeloma defined by absence of detectable paraprotein in serum and/or urine by immunoelectropheresis or immunofixation, and <5% plasma cells in the bone marrow), not qualifying for treatment protocols of higher priority.

2) Age 18 to 65 years of age.

3) Adequate renal function as defined by estimated serum creatinine clearance >50 ml/min and serum creatinine <1.8 mg/dL.

4) Adequate hepatic function, as defined by SGPT <3 X upper limit of normal; serum bilirubin and alkaline phosphatase <2 X upper limit of normal, or considered not clinically significant.

5) Adequate pulmonary function with FEV1, FVC, and DLCO >50%. Exceptions may be allowed for patients with pulmonary involvement after discussing with PI.

6) Adequate cardiac function with left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.

7) Zubrod performance score <2.

8) Patients receiving an allogeneic transplant must have an HLA matched, or one A, B, or DR mismatched related donor. Unrelated donor must be matched at A, B, and DR (defined as A, B serologic matched and DRB1 molecular matched). Donor must be willing to donate peripheral blood or bone marrow progenitor cells.

9) Patient and donor should be willing to participate in the study by providing written consent.

10) Female patient must not be pregnant and have negative pregnancy.

Exclusion Criteria:1) Patients with unresolved grade >/= 3 non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI.

2) Patients with active CNS disease.

3) Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.

4) Uncontrolled infection, including HIV or HTLV-1 infection.

5) Patients who have had a previous autologous or allogeneic stem cell transplant during the past year.

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Links
Registration Number: NCT00427765
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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