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Study Summary
No. 2004-0309:.......Lymphoma......Issa F. Khouri......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2004-0309
Study Title:Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen for Advanced/Recurrent Mantle Cell Lymphoma
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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:LymphomaSupported By:N/A
Phase of Study:N/AReturn
Visit:
At least twice weekly after discharge, up to day 100.
Treatment
Agents:
Campath-1H
Cyclophosphamide
Fludarabine
Rituxan
Home Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
30 days
Description/
Intervention:
The goal of this clinical research study will look at whether a transplant of
blood stem cells, given after treatment with low dose chemotherapy and
rituximab, will help to control mantle cell lymphoma. The safety of this
combination treatment will also be studied.
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Study Objectives / Outcomes
1. To determine the safety and efficacy of non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for patients with advanced or recurrent mantle cell lymphoma.

2. To determine factors associated with response and durable remission in patients receiving rituximab, cyclophosphamide, and fludarabine in preparation for allogeneic stem cell transplantation.
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Study Status Information
Study Activation / Registration Date:01/11/2005
IRB Review and Approval Date:11/17/2004
Study Type:Therapeutic
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 can be as old as 70 years.

2) They must have a diagnosis of MCL, either (1) Recurrent, (2) Newly diagnosed (after cytoreduction with conventional chemotherapy) but with high-risk features (blastic or blastoid features, leukemic phase, or elevated B^2 microglobulin (> 3).

3) Patients that have received prior conventional chemotherapy but have not achived CR.

4) Disease must be chemosensitive, (ie, patients must not have had a partial response to prior therapy).

5) Patients whose disease failed to respond to a previous autologous transplantation may also be eligible.

6) Patients must have a matched or 1 antigen mismatched sibling or unrelated donor.

7) PS </= 2.

8) Inclusion criteria for Immunomodulation Post transplantation: Patients can be as old as 70 years. Patients must have a diagnosis of MCL or CLL with one of the following characteristics: 1. Patients who develop disease progression or do not experience a CR within 3 months post-allogeneic transplantation 2. Patients with a weak chimerism (any mixed chimerism of donor T cells in patients receiving Campath by day 90, and less than 20% for patients not receiving Campath) or a drop of 20% or more with an amount of donor cells present in the blood < 50% by PCR .

9) Continued from Inclusion # 8: Patients must have the same donor of the original transplant willing to donate lymphocytes. 4. PS </ 2.

Exclusion Criteria:1) Past history of anaphylaxis following exposure to rat- or mouse-derived CDR-grafted humanized monoclonal antibodies.

2) Less than 4 weeks since prior chemotherapy counted from first day of treatment regimen.

3) Pregnancy or lactation.

4) HIV or HTLV-I positivity.

5) Serum creatinine concentration > 1.6 mg/dl or serum bilirubin > 2.0 mg/dl unless due to tumor

6) pulmonary function test - carbon monoxide diffusing capacity < 40%

7) cardiac ejection fraction < 40% of predicted levels (by multiple-gated acquisition or echocardiography).

8) Severe concomitant medical or psychiatric illness.

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Links
Registration Number: NCT00525876
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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