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Study Summary
No. 2008-0149:.......Lymphoma......Michelle A. Fanale......Lymphoma
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Study Summary Title
Study Summary
Number:
2008-0149
Study Title:A Phase II, Single-Arm, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of Multiple Doses of Apomab Administered Intravenously in Combination with Rituximab in Patients with Follicular, CD 20-Positive B-Cell Non-Hodgkin's Lymphoma that has Progressed Following Previous Rituximab Therapy
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Physician New Patient Referral
Name:Michelle A. FanalePatients 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:Genentech, Inc.
Phase of Study:Phase IIReturn
Visit:
Screening Day, Days 1,8 and 15 of all Cycles, One visit after Cycle 3, prior to
Cycle 4. End of treatment, Follow-ups (at 8, 12, 18, 24, 30, and 36 months).
Treatment
Agents:
Apomab
Rituximab
Home Care:N/A
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
This goal of this clinical research study to learn if apomab when given in
combination with rituximab can help to control follicular, CD20-positive B-cell
NHL. The safety of this combination will also be studied.
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Study Objectives / Outcomes
Primary Objectives
The primary objectives of this study are the following:
• To evaluate the safety and tolerability of Apomab when combined with rituximab for the treatment of patients with relapsed follicular, CD20-positive B-cell NHL
• To make a preliminary assessment of the efficacy of Apomab when combined with rituximab for the treatment of patients with relapsed follicular, CD20-positive B-cell NHL, as measured by objective response rate

Secondary Objectives
The secondary objectives of this study are the following:
• To make a preliminary assessment of the efficacy of Apomab when combined with rituximab for the treatment of patients with relapsed follicular, CD20-positive B-cell NHL, as measured by progression-free survival, duration of response, and overall survival
• To evaluate the serum pharmacokinetics of Apomab and rituximab when combined for the treatment of patients with relapsed follicular, CD20-positive B-cell NHL

Exploratory Objectives
The exploratory objectives of this study are the following:
• To make a preliminary assessment of biologic markers that may act as indicators of Apomab activity
• To evaluate the distribution of Fcg receptor (FcgR) polymorphisms among study participants and to assess their potential to affect clinical outcome
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Study Status Information
Study Activation / Registration Date:03/09/2009
IRB Review and Approval Date:08/12/2008
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:50
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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) Signed Informed Consent Form

2) Age >/= 18 years

3) Diagnosis of follicular, CD20-positive B-cell NHL classified as Grade 1, 2, or 3a according to the WHO classification of malignant lymphomas

4) Progression of disease after an objective response (CR/CRu or PR) or SD according to revised IWG criteria lasting > 6 months following completion of the most recent rituximab-containing regimen: A rituximab-containing regimen is defined as rituximab as a single agent during induction and/or maintenance, or in combination with other agents.

5) Measurable disease (according to modified IWG Criteria)

6) ECOG performance status of 0 or 1

7) Life expectancy of > 3 months

8) Willingness and capability to be accessible for follow-up until study termination or death

9) For patients of reproductive potential (both males and females), use of a reliable means of contraception (e.g., contraceptive pill, intrauterine device [IUD], barrier methods) throughout the trial and for 1 year following their last exposure to study treatment

Exclusion Criteria:1) A. Cancer History - Grade 3b follicular lymphoma (according to the WHO classification) or histologic transformation from follicular lymphoma to aggressive lymphoma

2) Prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of lymphoma progression at baseline (i.e., >/= 50% increase in the product of the longest perpendicular diameters of the lesion [greatest transverse diameter × perpendicular diameter] when compared with the nadir of lesion dimensions following radiotherapy and > 1.5 cm in the greatest transverse diameter)

3) Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1 or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1

4) Patients who received prior radio-immunotherapy for relapsed or refractory follicular NHL at least 1 year prior to first administration of study drug (i.e., rituximab) may participate if they meet minimal study requirements for peripheral blood counts (see below) and do not demonstrate evidence of myelodyplastic syndrome (MDS) on their screening bone marrow biopsy (as evidenced by cytogenetic or FISH criteria).

5) Concurrent systemic corticosteroid therapy (except low-dose corticosteroid therapy used to treat an illness other than lymphoma or single doses of up to 100 mg hydrocortisone, administered as prophylaxis against rituximab-mediated infusion reactions)

6) Other invasive malignancies within 3 years prior to first study drug administration (i.e., rituximab) except for adequately treated (with curative intent) basal or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, limited-stage bladder cancer, or other cancers from which the patient has been disease-free for at least 3 years.

7) History or evidence on physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, CNS lymphoma, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)

8) Prior treatment with agonistic DR4 or DR5 antibodies or Apo2L/TRAIL

9) B. General Medical Concerns - Current or recent (within the 28 days prior to Cycle 1, Day 1) participation in another experimental drug study

10) Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction within 1 year prior to Cycle 1, Day 1, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication within 1 year prior to Cycle1, Day 1, or Grade II or greater peripheral vascular disease at study entry

11) Active infection requiring parenteral antibiotics on Cycle 1, Day 1

12) Major surgical procedure (excluding lymph node biopsy) or significant traumatic injury within 28 days prior to Cycle 1, Day 1, or anticipation of need for major surgical procedure during the course of the study

13) Pregnancy (positive pregnancy test) or breast feeding

14) Serious, non-healing wound, ulcer, or bone fracture

15) Laboratory values: ANC < 1500/uL (may not be treated with G-CSF to maintain or exceed this level); Platelet count < 75,000/uL; Total bilirubin > 1.6 mg/dL; AST or ALT > 2.5 × the upper limit of normal (ULN); Serum creatinine > 2.0 mg/dL or measured creatinine clearance </= 50 mL/min; Hemoglobin < 9 g/dL (may not be transfused or treated with erythropoietin to maintain or exceed this level)

16) Known human immunodeficiency virus (HIV) infection, seropositivity for hepatitis B surface antigen (HBsAg), hepatitis B IgG or IgM core antibody, or hepatitis C virus (HCV) antibody

17) History of other disease, metabolic dysfunction, physical finding, or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications

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Links
Registration Number: NCT00517049
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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