MDACC Study Summary ID03-0287

Study Summary
No. ID03-0287:.......Lymphoma......Peter McLaughlin......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	ID03-0287

Study Title:	A Phase II Study of R-FND, Followed by Zevalin Radioimmunotherapy, and Subsequent Maintenance Rituximab for Advanced Stage Follicular Lymphoma with High-Risk Features

Physician

New Patient Referral



Name:	Peter McLaughlin	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:	N/A

Phase of Study:	Phase II	Return Visit:	Approximately every 3 months

Treatment Agents:	Fludarabine Mitoxantrone Rituximab	Home Care:	Patients may receive their chemotherapy, labs, follow-up visits at home provided the patient and the outside physician agrees to comply with the standard guidelines for therapy outside of MDACC

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	not applicable - this is an outpatient study - hospitalization is rare


Description/ Intervention:	The goal of this clinical research study is to learn if chemotherapy given with rituximab, followed by Ibritumomab tiuxetan (Zevalin), and then followed by rituximab can help to control lymphoma. The safety of this treatment schedule will also be studied.

Study Objectives / Outcomes

1)To assess whether the time to progression for these high-risk patients can be prolonged to a median of 36 months, compared to the historical expectation of approximately 24 months.

2) To assess the tolerance and efficacy of Y2B8 (Zevalin) after R-FND (rituximab, fludarabine, mitoxantrone, dexamethasone) in patients with high-risk stage III-IV follicular lymphoma

3) To assess overall response, failure-free survival, and survival of this strategy compared to our historical experience with FND (fludarabine, mitoxantrone, dexamethasone) alone or R-FND

4) To assess the tolerance and efficacy of maintenance therapy with rituximab.

5) To maximize the 12-month molecular remission rate for patients with high-risk stage III-IV follicular lymphoma

6) to correlate the results of quantitative PCR assay with classical PCR and with clinical outcome

Study Status Information



Study Activation / Registration Date:	06/29/2004

IRB Review and Approval Date:	07/16/2003

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	N/A

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 high-risk Ann Arbor stage III-IV follicular lymphoma. High-risk is defined by advanced stage (III or IV), plus any 2 of the following features: age 60 or greater; elevated LDH; Hgb < 12; or number of involved nodal sites 5 or more .

2) Patients will be previously untreated.

3) Adequate organ function.

4) Follicular lymphoma, grade 3 (follicular large cell lymphoma): If eligible for a current large cell lymphoma protocol, that alternative protocol is recommended, particularly grade 3b or FLCL patients characterized as large non-cleaved cell. However, both FND and rituximab have established efficacy in FLCL, so if a patient is not eligible for a protocol for aggressive lymphoma (e.g., because of SCCL in the marrow), then registration on this trial is permitted.

5) Biopsy or FNA material is strongly recommended for bcl-2 studies to verify rearrangement status of all patients who are designated "germline". (see section 6.4). For other patients, tissue availability is desirable but not mandatory.

6) Patients must have a performance status of Zubrod 3 or better

7) Patients must have adequate renal and hepatic function (creatinine < 2mg%; bilirubin < 2 mg%). Patients with renal or liver dysfunction due to organ infiltration by lymphoma may be eligible after discussion with the study chairman.

8) Patients may not receive other concurrent chemotherapy, radiotherapy, or immunotherapy.

9) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.

Exclusion Criteria:

1) Patients who are unable or unlikely to be able to adhere to the treatment plan or to return to Houston for follow-up visits because of geographical, economic, emotional, or social considerations are not eligible for this study. Note: some follow-up care may be provided by outside physicians as long as the MDACC protocol for outside physician participation is strictly adhered to.

2) Patients with an absolute peripheral granulocyte count of < 1,000 and platelet count < 100,000 unless due to marrow infiltration or hypersplenism.

3) Patients with organ dysfunction, including bilirubin of > 2 mg% or serum creatinine level > 2 mg%, unless the alteration is due to lymphoma.

4) Patients with HIV infection should not be registered on this protocol.

5) Patients with an antecedent malignancy whose prognosis is poor (< 90% probability of surviving for 5 yrs).

6) All patients should have a cardiac ejection fraction of 50% or more by echocardiography or MUGA.

7) Patients who will not accept transfusions of blood products or supportive care measures such as antibiotics are not eligible for this study.

8) Female patients must not be pregnant or lactating, and men and women of reproductive potential must follow accepted birth control methods.

9) Patients who have received prior murine antibody therapy will be excluded.

10) Patients with evidence of active or prior infection of Hepatitis B are excluded. (Note: Persons vaccinated for Hepatitis B who have + antibodies are not excluded).

Links

Registration Number: NCT00290511
Study Information on Clinical Trials Registry (clinicaltrials.gov)