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Study Summary
No.
2009-0163:
.......
Lymphoma
......
Sattva S. Neelapu
......
Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:
2009-0163
Study Title:
Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in combination with Rituximab in Patients with Relapsed Follicular Lymphoma
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Physician
New Patient Referral
Name:
Sattva S. Neelapu
Patients Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:
Lymphoma/Myeloma
Referring 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
.
General Information
Disease Group:
Lymphoma
Supported By:
Cure Tech Ltd
Phase of Study:
Phase II
Return
Visit:
Pre-treatment, days 1, 2, 7, 14, 17, 24, 29, 31, 38, 43, 57, 85, and weeks 16,
20, 24, 28, 32, 36, 40, 44, 52, 64, 76, 88, 100, 112, and 124.
Treatment
Agents:
CT-011 Monoclonal Antibody
Rituximab
Home Care:
N/A
Treatment Loc:
Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to learn if the combination of the
immunotherapy drugs, CT-011 and rituximab, can help control follicular
lymphoma. The safety of this drug combination will also be studied.
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Study Objectives / Outcomes
Primary Objective
To determine the overall response rate.
Secondary Objectives
To determine the safety and toxicity
To determine the complete response rate
To determine the time to progression
To determine whether administration of CT-011 enhances the function of tumor-specific T cells and natural killer cells
To evaluate the immunogenicity and pharmacokinetics of CT-011
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:
01/08/2010
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) Patients with histologic proof of follicular lymphoma grade 1 or grade 2 relapsing after at least 1 but no more than 4 prior systemic therapies.Patients may have had prior local radiation therapy in addition to up to 4 prior systemic therapies. History of total body irradiation will be considered as prior systemic therapy.
2) If patient received prior rituximab-based therapy, should have rituximab sensitive disease defined as a complete or partial response of at least 6 months duration with the rituximab-based regimen.
3) Patients must be >= 18 years of age.
4) Should have measurable (>= 1.5 cm) disease.
5) ECOG performance status of 0 or 1.
6) At least 4 weeks from last chemotherapy, immunotherapy, radiation therapy, monoclonal antibody therapy, or experimental therapy and must have recovered from acute toxic effects of prior therapy.
7) Absolute neutrophil count >= 1.5 × 10^9/L.
8) Platelets >= 50 × 10^9/L.
9) Absolute lymphocyte count >= 0.6 × 10^9/L.
10) Adequate renal function with creatinine <= 1.5 × the upper limit of normal (ULN).
11) Adequate hepatic function with total bilirubin <= 1.5 mg/dL; AST and ALT <= 2.5 × ULN.
12) Women of child-bearing potential (i.e., woman has not been naturally postmenopausal for at least 24 consecutive months or not surgically sterile) and sexually active men must agree to use 2 acceptable contraceptive methods during this study. One of the 2 methods of birth control must be a condom. Acceptable methods of birth control in combination with condoms include diaphragm, birth control pills, injections, intrauterine device, and/or under-the-skin implants. Men and women must agree to maintain effective contraception for up to 3 months after the last dose of drug is administered.
13) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
Exclusion Criteria:
1) Patients positive for HIV, hepatitis B surface antigen, or hepatitis C antibody.
2) Patients requiring concurrent immunosuppressive therapy are excluded. Inhaled or topical steroids for treating mild to moderate respiratory illnesses, allergies, skin rashes or ocular inflammations are allowed.
3) History of CNS lymphoma.
4) Active or history of autoimmune disease except Hashimoto's thyroiditis. Patients with type I diabetes mellitus are excluded.
5) Active infection or other serious intercurrent medical illness
6) New York Heart Association Class III or IV disease.
7) Pregnant or nursing.
8) History of allogeneic stem cell transplantation.
9) Other concurrent chemotherapy, radiotherapy, immunotherapy, or investigational therapy
10) Any other malignancy except basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ treated with curative intent. Any cancer from which the patient has been disease free for at least 5 years is permissible.
11) Any underlying medical condition which, in the Principal Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events.
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Links
Registration Number:
NCT00904722
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results
Return to Clinical Trials at M.D. Anderson Cancer Center
