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Study Summary
No. 2006-0066:.......Leukemia; Lymphoma......Issa F. Khouri......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2006-0066
Study Title:Bortezomib (Velcade®) and Reduced-Intensity Allogeneic Stem Cell Transplantation for Patients with Lymphoid Malignancies
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Physician New Patient Referral
Name:Issa F. KhouriPatients 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:713-792-8750
Contact us about clinical trials
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General Information
Disease Group:Leukemia
Lymphoma
Supported By:N/A
Phase of Study:Phase IIReturn
Visit:
Every 3 months for the first year, then every 6 months while the patient is on
study.
Treatment
Agents:
Carmustine
Cytarabine
Etoposide
Melphalan
Rituximab
Velcade
Home Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
3-4 weeks in the hospital.
Description/
Intervention:
The goal of this clinical research study is to find the highest tolerable dose
of Velcade (bortezomib) that can be given with BEAM (carmustine, etoposide,
cytarabine and melphalan) and rituximab in patients with lymphoma who receive a
stem cell transplant.
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Study Objectives / Outcomes
1 Primary Objective:

1. To determine the maximum tolerated dose (MTD) and dose limiting toxicity
(DLT) of VELCADE® (bortezomib) in patients with lymphoid malignancies
undergoing allogeneic peripheral blood stem cell or bone marrow
transplantation.

2. To determine the 1-year disease-free-survival (DFS) and the toxicity profile
of VELCADE® (bortezomib) in patients with lymphoid malignancies
undergoing allogeneic peripheral blood stem cell or bone marrow
transplantation.

2. Secondary Objective:

1. To compare the incidence of GVHD with historical controls.
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Study Status Information
Study Activation / Registration Date:02/13/2007
IRB Review and Approval Date:09/20/2006
Study Type:Phase Ii Or Phase I/Ii
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) Up to 70 years of age .

2) Any histological subtype of CD20+ lymphoid malignancies or T-cell lymphoid malignancies.

3) Patients with CD20+ lymphoid malignancies in relapse after failing >/= 1 prior regimen of conventional treatment and not eligible for non-myeloablative transplant. Patients with T-Cell lymphoid malignancies can either be in relapse or newly diagnosed with high risk features (such as high IPI of >/= 2).

4) Patients with prior non-myeloablative transplant are eligible if not from the same donor.

5) A fully-matched or one-antigen mismatched sibling or unrelated donor.

6) Left ventricular EF >/= 40% with no uncontrolled arrythmias or symptomatic heart disease..

7) FEV1, FVC and DLCO >/= 40%.

8) Serum creatinine < 1.8 mg/dL. Serum bilirubin < 3X upper limit of normal,

9) SGPT < 3X upper limit of normal.

10) Voluntary signed, written IRB-approved informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

11) Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:1) Past history of anaphylaxis following exposure to rituximab or VELCADE®, boron or mannitol

2) History of grade 3 or 4 NCI toxicity with prior VELCADE® therapy

3) Patient with active CNS disease.

4) Pregnant (Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.

5) Known infection with HIV, HTLV-I, Heptitis B, or Hepatitis C.

6) Patients with other malignancies diagnosed within 2 years prior to Study Day -13 (except skin squamous or basal cell carcinoma).

7) Active uncontrolled bacterial, viral or fungal infections.

8) Major surgical procedure or significant traumatic injury within 4 weeks prior to Day -13.

9) Serious, non-healing wound, ulcer, or bone fracture.

10) History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 3 months prior to Day -13.

11) History of Stroke within 6 months.

12) Myocardial infarction within the past 6 months prior to Study Day 1, or has New York Heart Association (NYHA) Class III or IV heart failure or arrythmia, unstable angina, uncontrolled congestive heart failure or arrythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.Prior to study entry, any ECG abnormality at screening must be documented by investigator as not medically relevant.

13) Uncontrolled hypertension(>/=140/90) .

14) Uncontrolled chronic diarrhea.

15) A prior allogeneic transplant from the same donor.

16) Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

17) Patient has received other investigational drugs within 3 weeks before enrollment.

18) Active peripheral neuropathy greater or equal to grade 2.

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Links
Registration Number: NCT00439556
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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