MDACC Study Summary 2006-0313

Study Summary
No. 2006-0313:.......Lymphoma......Peter McLaughlin......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2006-0313

Study Title:	Randomized, Open-Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-Cell Lymphoma

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:	Weekly x 8 weeks; then Months 3, 6, 9, 12, 18, 21, and 24.

Treatment Agents:	GM-CSF Rituximab	Home Care:	SC sargramostim 250 micrograms may be self-administered on Days 1, 3 and 5 or given in the hospital or clinic. Sargramostim injections will be repeated in this manner 3 times weekly for the next 7 weeks.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn more about how patients with lymphoma will respond to treatment with rituximab given with sargramostim (GM-CSF). The safety of this drug combination will also be studied.

Study Objectives / Outcomes

The overall objective of this study is to compare the efficacy of standard rituximab monotherapy
to rituximab plus sargramostim, as measured by confirmed and unconfirmed complete response
(CR+CRu) at 8 weeks with confirmation at 12 weeks.

The secondary objectives of this study are the determination of the: safety, overall response rate (ORR), best response, time to best response, response duration, progression-free survival, cost effectiveness, and deoxyribonucleic acid (DNA) Fc gamma analysis.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	07/19/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	196

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-confirmed, CD20-positive, follicular B-cell lymphoma, grades 1-3a and stages I-IV (CD-20 positivity may be determined by histochemistry, fluorescent cell sorting, or any other standard technique.).

2) Patients must have received at least 1 prior therapy for follicular B-cell lymphoma. This may include relapsed patients, who received prior rituximab monotherapy or rituximab-containing regimen with time to relapse >/=6 months post last dose of rituximab. (a) Patients who have received prior cytotoxic therapy must be at least 4 weeks post therapy; (b) Patients who have received prior therapy with nitrosourea must be at least 6 weeks post therapy; (c) Patients who have received prior experimental or investigational therapies must be at least 4 weeks post therapy; Continued in Incl. # 3 below.

3) Continued from Inclusion # 2: (d) Patients who have received radioimmunotherapy must be at least 6 months post therapy; (e) Patients who have received an autologous transplant must be at least 12 weeks post transplant

4) Measurable disease consisting of at least one lesion measuring 2 cm and documented progression. Progression will be defined using the International Working Group Criteria.

5) Males or females, 18 years or older

6) Life expectancy of >/= 6 months

7) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

8) Required initial hematologic data including (except if known bone marrow involvement by lymphoma): Hemoglobin >/= 8.0 gm/dL; White blood cell count >/= 3.0 x 10^3/mm^3(x 10^9/L); Absolute granulocyte count >/= 1.5 x 10^3/mm^3(x 10^9/L); Platelet count >/=75 x 10^3/mm^3(x 10^9/L)

9) Adequate renal function (serum creatinine within 2.5 X upper limit of normal (ULN)

10) Adequate liver function (alanine aminotransferase [ALT], aspartate aminotransferase [AST] </=2.5 X ULN), unless due to known organ involvement by lymphoma

11) Ability to understand and the willingness to sign a written informed consent document

12) During the 12 week treatment phase, men and women of child bearing potential must use medically acceptable form of birth control or barrier protection plus spermacide.

Exclusion Criteria:

1) Rituximab-refractory (defined as patients who relapse within 6 months of the last dose of rituximab monotherapy or a rituximab-containing chemotherapy regimen or patients who fail to achieve a PR or CR from the rituximab-containing regimen)

2) Previous allogeneic stem cell transplant

3) Presence of known central nervous system lymphoma

4) Diagnosis of chronic lymphocytic leukemia

5) Diagnosis of small lymphocytic lymphoma

6) Diagnosis of previous hematological malignancy

7) Active second malignancy requiring chemotherapy or radiation treatment (with the exception of non-melanoma skin cancer, in situ carcinoma of the uterine cervix, localized prostate cancer, or completely resected stage I, II disease with no evidence of recurrent cancer from which patient has remained disease free for >3 years).

8) Current or previous transformation to large cell or immunoblastic lymphoma. If clinical features of transformation are present, an excisional or core biopsy is required to exclude transformation. Clinical signs include: (a) Systemic symptoms (active B-symptoms, weight loss >10%); (b) Rapidly progressive lymphadenopathy; (c) Elevated LDH (2.5 X ULN)

9) Active infection

10) Active hepatitis B antigenemia based on positive surface antigen test

11) History of HIV infection

12) Pregnancy

13) Known allergies to yeast-derived products

14) Known history or significant allergic reaction to monoclonal antibody therapy that required discontinuation of therapy

15) Active autoimmune disease

Links

Registration Number: NCT00739063
Study Information on Clinical Trials Registry (clinicaltrials.gov)