Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 81 patients with lymphoid malignancy were enrolled from 22 March 2007 until 31 January 2008, of which 13 were in Phase I and 68 in Phase II. This study was conducted by 11 investigators at 11 sites in U.S. Primary efficacy analysis was based on Phase II patients so only results from Phase II are posted.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was screening period of up to 21 days, after which if all inclusion/exclusion criteria were met, patients were dosed with fostamatinib treatment for a treatment period of 8 weeks. Patients could then continue treatment until disease progression, toxicity or withdrawal from the study

Reporting Groups

	Description
Phase II: DLBCL	Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID	Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas	Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase I: 200mg R788 BID	Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
Phase I: 250mg R788 BID	Patients who received 250mg R788 orally twice daily (PO BID) in Phase I

Participant Flow for 2 periods

Period 1:   Phase II (8 Weeks)

	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas	Phase I: 200mg R788 BID	Phase I: 250mg R788 BID
STARTED	23	21	24	0	0
COMPLETED	11	18	21	0	0
NOT COMPLETED	12	3	3	0	0
Lost to Follow-up	1	0	0	0	0
Adverse Event	0	1	1	0	0
Withdrawal by Subject	1	0	0	0	0
Physician Decision	1	0	0	0	0
Lack of Efficacy	9	2	1	0	0
Ongoing	0	0	1	0	0

Period 2:   Phase I (28 Days)

	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas	Phase I: 200mg R788 BID	Phase I: 250mg R788 BID
STARTED	0	0	0	6	7
COMPLETED	0	0	0	5	4
NOT COMPLETED	0	0	0	1	3
Adverse Event	0	0	0	1	0
Lack of Efficacy	0	0	0	0	3

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Phase II: DLBCL	Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
Phase II: 250mg R788 BID	Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
Phase II: Other Lymphomas	Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
Phase I: 200mg R788 BID	Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
Phase I: 250mg R788 BID	Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
Total	Total of all reporting groups

Baseline Measures

	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas	Phase I: 200mg R788 BID	Phase I: 250mg R788 BID	Total
Overall Participants Analyzed  [Units: Participants]	23	21	24	6	7	81
Age  [Units: Years] Mean (Full Range)	63.0   (41 to 87)	59.0   (41 to 74)	62.0   (51 to 77)	78.5   (70 to 91)	61   (52 to 80)	61.5   (41 to 87)
Gender  [Units: Participants]
Female	5	8	7	4	5	29
Male	18	13	17	2	2	52
Race/Ethnicity, Customized  [Units: Participants]
Caucasian	20	19	21	6	5	71
Black/African American	2	0	3	0	1	6
Asian	0	2	0	0	1	3
Other: Russian	1	0	0	0	0	1

1.  Primary:

Overall Response Rate as Assessed According to the“Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).   [ Time Frame: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response . (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) ]

2.  Primary:

Clinical Benefit Rate as Assessed According to the “Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).   [ Time Frame: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) ]

3.  Secondary:

Progression Free Survival (PFS)   [ Time Frame: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) ]

4.  Secondary:

Overall Survival (OS)   [ Time Frame: Overall survival is measured from the time of first administration of study drug to death. (Maximum duration of treatment 511days, Maximum duration of follow-up 812 Days) ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This is a small, non-randomized study. Comparisons between the 3 groups cannot be reliably made and should be interpreted with caution.