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Study Summary
No. ID01-031:.......Lymphoma......Alma [Lymphoma - VP Medical Affairs] Rodriguez......Lymphoma
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Study Summary Title
Study Summary
Number:
ID01-031
Study Title:A Phase II Study of CHOP+Rituximab (CHOP or R-CHOP) With Substitution of Liposomal Vincristine for Free Vincristine for Patients with Untreated Aggressive Non-Hodgkin's Lymphoma
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Physician New Patient Referral
Name:Alma [Lymphoma - VP Medical Affairs] RodriguezPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LymphomaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:INEX Pharmaceuticals Corporation
Phase of Study:Phase IIReturn
Visit:
Every week for lab tests; every 3 weeks for treatment
Treatment
Agents:
RituximabHome Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
To determine tumor response, duration of response, progression-free survival, event-free survival, disease-free survival, and toxicities for patients with previously untreated aggressive non-Hodgkin's Lymphoma after CHOP or R-CHOP with Liposomal vincristine instead of Vincristine Sulfate.
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Study Status Information
Study Activation / Registration Date:03/14/2001
IRB Review and Approval Date:02/21/2001
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) Histologically proven diagnosis of untreated aggressive non-Hodgkin's lymphoma. This includes: diffuse large B-cell lymphoma, anaplastic, 1 degree mediastinal, peripheral T-cell lymphomas and other T-cell types, follicular large cell, and Burkitt-like large B-cell lymphoma.

2) No prior treatment.

3) Signed informed consent form.

4) Adequate bone marrow reserve (ANC > 1,000/L, Plt > 100,000 L) unless due to hypersplenism or bone marrow infiltration.

5) LVEF >/= 50% by MUGA scan or echocardiogram.

6) Serum creatinine < 2 mg/dL, serum bilirubin < 2 mg/dL.

7) Not eligible for protocol of higher priority. This protocol will be first priority for patients older than 60 years with tumor score >/= 3. It will be first priority for those with anaplastic large cell lymphoma and a tumor score </= 2, and second priority for all others.

8) HIV-1/2 negative (other protocol available for HIV-postive patients).

9) Pregnant women are excluded. Women of childbearing potential should practice adequate contraception.

10) No psychiatric illness that precludes understanding concepts of the trial or signing informed consent.

11) No other major life-threatening illness that may preclude chemotherapy.

12) Zubrod performance status </= 3.

13) Primary testicular and primary CNS lymphomas are excluded.

Exclusion Criteria:N/A

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Links
Registration Number:

Other Links:
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Results


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