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

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ClinicalTrials.gov Identifier: NCT00446095

Recruitment Status : Completed

First Posted : March 12, 2007

Results First Posted : December 18, 2014

Last Update Posted : September 19, 2016

Sponsor:

Information provided by (Responsible Party):

Rigel Pharmaceuticals

Study Type	Interventional
Study Design	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Lymphoma
Intervention	Drug: fostamatinib
Enrollment	81

Participant Flow

Recruitment Details	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	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


Arm/Group Title	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas	Phase I: 200mg R788 BID	Phase I: 250mg R788 BID
Arm/Group Description	Patients with diffuse large B-cell ...	Patients who received 250mg R788 or...	Patients with mantle cell lymphoma,...	Patients who received 200mg R788 or...	Patients who received 250mg R788 or...
Arm/Group Description	Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II	Patients who received 250mg R788 orally twice daily (PO BID) in Phase II	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	Patients who received 200mg R788 orally twice daily (PO BID) in Phase I	Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
Period Title: Phase II (8 Weeks)
Started	23	21	24	0	0
Completed	11	18	21	0	0
Not Completed	12	3	3	0	0
Reason Not Completed
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 Title: Phase I (28 Days)
Started	0	0	0	6	7
Completed	0	0	0	5	4
Not Completed	0	0	0	1	3
Reason Not Completed
Adverse Event	0	0	0	1	0
Lack of Efficacy	0	0	0	0	3

Baseline Characteristics

Arm/Group Title		Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas	Phase I: 200mg R788 BID	Phase I: 250mg R788 BID	Total
Arm/Group Description		Patients with diffuse large B-cell ...	Patients who received 250mg R788 or...	Patients with mantle cell lymphoma,...	Patients who received 200mg R788 or...	Patients who received 250mg R788 or...	Total of all reporting groups
Arm/Group Description		Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II	Patients who received 250mg R788 orally twice daily (PO BID) in Phase II	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	Patients who received 200mg R788 orally twice daily (PO BID) in Phase I	Patients who received 250mg R788 orally twice daily (PO BID) in Phase I	Total of all reporting groups
Overall Number of Baseline Participants		23	21	24	6	7	81
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Full Range) Unit of measure: Years
	Number Analyzed	23 participants	21 participants	24 participants	6 participants	7 participants	81 participants
		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)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	23 participants	21 participants	24 participants	6 participants	7 participants	81 participants
	Female	5 21.7%	8 38.1%	7 29.2%	4 66.7%	5 71.4%	29 35.8%
	Male	18 78.3%	13 61.9%	17 70.8%	2 33.3%	2 28.6%	52 64.2%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	23 participants	21 participants	24 participants	6 participants	7 participants	81 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

Outcome Measures

1.Primary Outcome


Title	Overall Response Rate as Assessed According to the“Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).
Description	Proportion of patients with Complete Response (CR) or Partial Response...
Description	Proportion of patients with Complete Response (CR) or Partial Response (PR). Revised Response Criteria for Malignant Lymphoma categorises the response of the treatment of a patient's tumour to; CR: the disappearance of all evidence of disease; PR: ≥ 50% decrease in the sum of the perpendicular diameters (SPD) of the six largest dominant nodes plus no increase in the size of other nodes and no new sites of disease; Stable Disease (SD): less than a PR but not progressive disease; Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Primary efficacy is based on Phase II patients only.
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)

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.


Arm/Group Title	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas	Phase 1: 200mg and 250mg R788 BID
Arm/Group Description:	Patients with diffuse large B-cell ...	Patients who received 250mg R788 or...	Patients with mantle cell lymphoma,...	Patients who received 200mg or 250m...
Arm/Group Description:	Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II	Patients who received 250mg R788 orally twice daily (PO BID) in Phase II	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	Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
Overall Number of Participants Analyzed	23	21	24	13
Measure Type: Number Unit of Measure: Participants
	5	2	7	1

2.Primary Outcome


Title	Clinical Benefit Rate as Assessed According to the “Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).
Description	Proportion of patients with Complete Response (CR), Partial Response (...
Description	Proportion of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
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)

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.


Arm/Group Title	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas	Phase 1: 200mg and 250mg R788 BID
Arm/Group Description:	Patients with diffuse large B-cell ...	Patients who received 250mg R788 or...	Patients with mantle cell lymphoma,...	Patients who received 200mg or 250m...
Arm/Group Description:	Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II	Patients who received 250mg R788 orally twice daily (PO BID) in Phase II	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	Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
Overall Number of Participants Analyzed	23	21	24	13
Measure Type: Number Unit of Measure: Participants
	9	13	14	9

3.Secondary Outcome


Title	Progression Free Survival (PFS)
Description	PFS: Time from date of first study drug administration to the date of ...
Description	PFS: Time from date of first study drug administration to the date of progressive disease as assessed according to the “Revised Response Criteria for Malignant Lymphoma”(Cheson 2007) or the date of death due to any cause, whichever occurred first.
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)

Outcome Measure Data

Analysis Population Description

Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.


Arm/Group Title	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas
Arm/Group Description:	Patients with diffuse large B-cell ...	Patients who received 250mg R788 or...	Patients with mantle cell lymphoma,...
Arm/Group Description:	Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II	Patients who received 250mg R788 orally twice daily (PO BID) in Phase II	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
Overall Number of Participants Analyzed	23	21	24
Median (95% Confidence Interval) Unit of Measure: Days
	83.0 (41.0 to 137.0)	141.0 (61.0 to 253.0)	126.0 (64.0 to 169.0)

4.Secondary Outcome


Title	Overall Survival (OS)
Description	OS: Time from date of first study drug administration to the date of d...
Description	OS: Time from date of first study drug administration to the date of death.
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)

Outcome Measure Data

Analysis Population Description

Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.


Arm/Group Title	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas
Arm/Group Description:	Patients with diffuse large B-cell ...	Patients who received 250mg R788 or...	Patients with mantle cell lymphoma,...
Arm/Group Description:	Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II	Patients who received 250mg R788 orally twice daily (PO BID) in Phase II	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
Overall Number of Participants Analyzed	23	21	24
Median (95% Confidence Interval) Unit of Measure: Days
	166.0 ^[1] (130.0 to NA)	NA ^[2] (NA to NA)	NA ^[2] (NA to NA)

[1]

The upper limit of the 95% CI for the median overall survival was not estimable due to small sample size and too few death events and therefore can't be presented.

[2]

The median overall survival could not be calculated due to too few death events.The upper & lower limits of the 95% CI for the median overall survival were not estimable due to small sample size and too few death events, therefore can't be presented.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas	Phase I: 200mg R788 BID	Phase I: 250mg R788 BID
Arm/Group Description	Patients with diffuse large B-cell ...	Patients who received 250mg R788 or...	Patients with mantle cell lymphoma,...	Patients who received 200mg R788 or...	Patients who received 250mg R788 or...
Arm/Group Description	Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II	Patients who received 250mg R788 orally twice daily (PO BID) in Phase II	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	Patients who received 200mg R788 orally twice daily (PO BID) in Phase I	Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
All-Cause Mortality
	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas	Phase I: 200mg R788 BID	Phase I: 250mg R788 BID
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas	Phase I: 200mg R788 BID	Phase I: 250mg R788 BID
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	14/23 (60.87%)	7/21 (33.33%)	10/24 (41.67%)	6/6 (100.00%)	3/7 (42.86%)
Blood and lymphatic system disorders
Febrile Neutropenia ^† 1	1/23 (4.35%)	1/21 (4.76%)	3/24 (12.50%)	0/6 (0.00%)	1/7 (14.29%)
Pancytopenia ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Neutropenia	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Cardiac disorders
Cardio-Respiratory Arrest ^† 1	2/23 (8.70%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Cardiac Arrest ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Myocardial Ischaemia ^† 1	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Cardiac failure	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Gastrointestinal disorders
Abdominal Pain ^† 1	2/23 (8.70%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Abdominal Pain Upper ^† 1	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Ascites ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Diarrhoea ^† 1	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Duodenal obstruction	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
General disorders
Pyrexia ^† 1	1/23 (4.35%)	0/21 (0.00%)	2/24 (8.33%)	1/6 (16.67%)	0/7 (0.00%)
Chest Pain ^† 1	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Infections and infestations
Pneumonia ^† 1	1/23 (4.35%)	1/21 (4.76%)	2/24 (8.33%)	2/6 (33.33%)	1/7 (14.29%)
Cellulitis ^† 1	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Gastroenteritis Viral ^† 1	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Lung Infection Pseudomonal ^† 1	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Pneumococcal Sepsis ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Sepsis ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	2/6 (33.33%)	0/7 (0.00%)
Staphylococcal Infection ^† 1	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Urinary Tract Infection ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	2/6 (33.33%)	0/7 (0.00%)
Klebsiella bacteraemia	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Metabolism and nutrition disorders
Dehydration ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Musculoskeletal and connective tissue disorders
Pathological Fracture ^† 1	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Tumour necrosis	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Nervous system disorders
Lethargy ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Spinal Cord Compression ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Syncope ^† 1	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Multifocal motor neuropathy	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Psychiatric disorders
Mental Status Changes ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Renal and urinary disorders
Renal Failure ^† 1	0/23 (0.00%)	1/21 (4.76%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Renal Failure Acute ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome ^† 1	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Dyspnoea Exacerbated ^† 1	1/23 (4.35%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Hypoxia ^† 1	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Dyspnoea	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Vascular disorders
Superior Vena Caval Occlusion ^† 1	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 9.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Phase II: DLBCL	Phase II: 250mg R788 BID	Phase II: Other Lymphomas	Phase I: 200mg R788 BID	Phase I: 250mg R788 BID
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	22/23 (95.65%)	21/21 (100.00%)	24/24 (100.00%)	6/6 (100.00%)	6/7 (85.71%)
Blood and lymphatic system disorders
Anaemia ^† 1	5/23 (21.74%)	7/21 (33.33%)	9/24 (37.50%)	4/6 (66.67%)	2/7 (28.57%)
Thrombocytopenia ^† 1	7/23 (30.43%)	5/21 (23.81%)	8/24 (33.33%)	4/6 (66.67%)	1/7 (14.29%)
Leukopenia ^† 1	1/23 (4.35%)	7/21 (33.33%)	2/24 (8.33%)	4/6 (66.67%)	1/7 (14.29%)
Neutropenia ^† 1	7/23 (30.43%)	9/21 (42.86%)	11/24 (45.83%)	4/6 (66.67%)	2/7 (28.57%)
Febrile neutropenia	1/23 (4.35%)	1/21 (4.76%)	3/24 (12.50%)	0/6 (0.00%)	1/7 (14.29%)
Bone marrow failure	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Cardiac disorders
Tachycardia ^† 1	3/23 (13.04%)	0/21 (0.00%)	2/24 (8.33%)	1/6 (16.67%)	1/7 (14.29%)
Atrial fibrillation	0/23 (0.00%)	1/21 (4.76%)	1/24 (4.17%)	1/6 (16.67%)	0/7 (0.00%)
Cardiac failure congestive	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	2/6 (33.33%)	0/7 (0.00%)
Cardiac failure	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	1/6 (16.67%)	0/7 (0.00%)
Myocardial ischaemia	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	1/7 (14.29%)
Palpitations	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Arrhythmia	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Intracardiac thrombus	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Ventricular tachycardia	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Ear and labyrinth disorders
Tinnitus	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Eye disorders
Conjunctival Haemorrhage ^† 1	0/23 (0.00%)	0/21 (0.00%)	2/24 (8.33%)	0/6 (0.00%)	0/7 (0.00%)
Vision Blurred ^† 1	0/23 (0.00%)	2/21 (9.52%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Eye swelling	1/23 (4.35%)	0/21 (0.00%)	1/24 (4.17%)	1/6 (16.67%)	0/7 (0.00%)
Lacrimation increased	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	1/6 (16.67%)	0/7 (0.00%)
Visual disturbance	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Gastrointestinal disorders
Diarrhoea ^† 1	8/23 (34.78%)	10/21 (47.62%)	12/24 (50.00%)	5/6 (83.33%)	5/7 (71.43%)
Nausea ^† 1	5/23 (21.74%)	11/21 (52.38%)	8/24 (33.33%)	0/6 (0.00%)	4/7 (57.14%)
Vomiting ^† 1	5/23 (21.74%)	4/21 (19.05%)	6/24 (25.00%)	3/6 (50.00%)	3/7 (42.86%)
Constipation ^† 1	4/23 (17.39%)	3/21 (14.29%)	3/24 (12.50%)	1/6 (16.67%)	1/7 (14.29%)
Frequent Bowel Movements ^† 1	0/23 (0.00%)	4/21 (19.05%)	4/24 (16.67%)	0/6 (0.00%)	0/7 (0.00%)
Abdominal Distension ^† 1	0/23 (0.00%)	3/21 (14.29%)	2/24 (8.33%)	1/6 (16.67%)	1/7 (14.29%)
Abdominal Pain Upper ^† 1	1/23 (4.35%)	1/21 (4.76%)	3/24 (12.50%)	0/6 (0.00%)	1/7 (14.29%)
Dyspepsia ^† 1	2/23 (8.70%)	3/21 (14.29%)	1/24 (4.17%)	1/6 (16.67%)	2/7 (28.57%)
Flatulence ^† 1	0/23 (0.00%)	3/21 (14.29%)	2/24 (8.33%)	0/6 (0.00%)	1/7 (14.29%)
Abdominal Pain ^† 1	1/23 (4.35%)	1/21 (4.76%)	2/24 (8.33%)	2/6 (33.33%)	1/7 (14.29%)
Dysphagia ^† 1	2/23 (8.70%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Hypoaesthesia Oral ^† 1	0/23 (0.00%)	2/21 (9.52%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Dry mouth	1/23 (4.35%)	0/21 (0.00%)	1/24 (4.17%)	1/6 (16.67%)	1/7 (14.29%)
Gastrooesophageal reflux disease	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	1/6 (16.67%)	0/7 (0.00%)
Haemorrhoidal haemorrhage	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Rectal haemorrhage	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	1/6 (16.67%)	0/7 (0.00%)
Stomach discomfort	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Abdominal discomfort	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Faeces discoloured	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Toothache	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
General disorders
Fatigue ^† 1	8/23 (34.78%)	13/21 (61.90%)	16/24 (66.67%)	5/6 (83.33%)	3/7 (42.86%)
Pyrexia ^† 1	8/23 (34.78%)	3/21 (14.29%)	7/24 (29.17%)	3/6 (50.00%)	1/7 (14.29%)
Oedema Peripheral ^† 1	4/23 (17.39%)	3/21 (14.29%)	4/24 (16.67%)	5/6 (83.33%)	0/7 (0.00%)
Asthenia ^† 1	2/23 (8.70%)	1/21 (4.76%)	1/24 (4.17%)	4/6 (66.67%)	3/7 (42.86%)
Axillary Pain ^† 1	2/23 (8.70%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Chills ^† 1	2/23 (8.70%)	1/21 (4.76%)	2/24 (8.33%)	1/6 (16.67%)	1/7 (14.29%)
Chest discomfort	1/23 (4.35%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Malaise	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	2/6 (33.33%)	0/7 (0.00%)
Chest pain	0/23 (0.00%)	0/21 (0.00%)	2/24 (8.33%)	0/6 (0.00%)	0/7 (0.00%)
Early satiety	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	1/6 (16.67%)	0/7 (0.00%)
Discomfort	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Nodule	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Secretion discharge	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Infections and infestations
Upper Respiratory Tract Infection ^† 1	2/23 (8.70%)	5/21 (23.81%)	5/24 (20.83%)	1/6 (16.67%)	1/7 (14.29%)
Bronchitis ^† 1	2/23 (8.70%)	2/21 (9.52%)	1/24 (4.17%)	0/6 (0.00%)	1/7 (14.29%)
Candidiasis ^† 1	1/23 (4.35%)	2/21 (9.52%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Gastroenteritis Viral ^† 1	0/23 (0.00%)	0/21 (0.00%)	2/24 (8.33%)	0/6 (0.00%)	0/7 (0.00%)
Influenza ^† 1	2/23 (8.70%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Pneumonia ^† 1	0/23 (0.00%)	0/21 (0.00%)	2/24 (8.33%)	2/6 (33.33%)	1/7 (14.29%)
Sinusitis ^† 1	1/23 (4.35%)	1/21 (4.76%)	2/24 (8.33%)	0/6 (0.00%)	1/7 (14.29%)
Urinary Tract Infection ^† 1	2/23 (8.70%)	2/21 (9.52%)	0/24 (0.00%)	2/6 (33.33%)	1/7 (14.29%)
Cellulitis	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	2/6 (33.33%)	0/7 (0.00%)
Sepsis	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	2/6 (33.33%)	0/7 (0.00%)
Gastroenteritis	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Herpes simplex	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	1/6 (16.67%)	0/7 (0.00%)
Clostridium difficile colitis	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Klebsiella bacteraemia	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Pneumonia primary atypical	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Viral infection	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Wound infection	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Injury, poisoning and procedural complications
Procedural Pain ^† 1	0/23 (0.00%)	2/21 (9.52%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Rib fracture	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	2/6 (33.33%)	0/7 (0.00%)
Donor site complication	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Excoriation	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Wound	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Investigations
Aspartate Aminotransferase Increased ^† 1	6/23 (26.09%)	4/21 (19.05%)	3/24 (12.50%)	0/6 (0.00%)	0/7 (0.00%)
Blood Lactate Dehydrogenase Increased ^† 1	5/23 (21.74%)	3/21 (14.29%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Blood Alkaline Phosphatase Increased ^† 1	4/23 (17.39%)	3/21 (14.29%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Alanine Aminotransferase Increased ^† 1	2/23 (8.70%)	3/21 (14.29%)	2/24 (8.33%)	0/6 (0.00%)	0/7 (0.00%)
Blood Bilirubin Increased ^† 1	1/23 (4.35%)	1/21 (4.76%)	3/24 (12.50%)	0/6 (0.00%)	0/7 (0.00%)
Blood Creatinine Increased ^† 1	0/23 (0.00%)	3/21 (14.29%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Blood Bicarbonate Increased ^† 1	2/23 (8.70%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Blood Phosphorus Decreased ^† 1	2/23 (8.70%)	0/21 (0.00%)	2/24 (8.33%)	1/6 (16.67%)	1/7 (14.29%)
Blood Sodium Decreased ^† 1	2/23 (8.70%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Haemoglobin Decreased ^† 1	2/23 (8.70%)	2/21 (9.52%)	2/24 (8.33%)	0/6 (0.00%)	0/7 (0.00%)
Weight Decreased ^† 1	2/23 (8.70%)	1/21 (4.76%)	2/24 (8.33%)	4/6 (66.67%)	1/7 (14.29%)
White Blood Cell Count Decreased ^† 1	1/23 (4.35%)	2/21 (9.52%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Heart rate increased	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Blood potassium decreased	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Breath sounds abnormal	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Cardioactive drug level increased	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Heart sounds abnormal	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Metabolism and nutrition disorders
Dehydration ^† 1	3/23 (13.04%)	0/21 (0.00%)	4/24 (16.67%)	2/6 (33.33%)	2/7 (28.57%)
Anorexia ^† 1	3/23 (13.04%)	1/21 (4.76%)	1/24 (4.17%)	2/6 (33.33%)	0/7 (0.00%)
Hyperglycaemia ^† 1	3/23 (13.04%)	1/21 (4.76%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Hypokalaemia ^† 1	3/23 (13.04%)	2/21 (9.52%)	2/24 (8.33%)	0/6 (0.00%)	1/7 (14.29%)
Hyperkalaemia ^† 1	0/23 (0.00%)	0/21 (0.00%)	2/24 (8.33%)	0/6 (0.00%)	0/7 (0.00%)
Hypocalcaemia ^† 1	2/23 (8.70%)	1/21 (4.76%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Hypomagnesaemia ^† 1	2/23 (8.70%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Hyponatraemia ^† 1	0/23 (0.00%)	0/21 (0.00%)	2/24 (8.33%)	0/6 (0.00%)	1/7 (14.29%)
Increased Appetite ^† 1	1/23 (4.35%)	2/21 (9.52%)	2/24 (8.33%)	0/6 (0.00%)	1/7 (14.29%)
Hypophosphataemia	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Food craving	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	5/23 (21.74%)	3/21 (14.29%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Muscle Spasms ^† 1	2/23 (8.70%)	5/21 (23.81%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Back Pain ^† 1	3/23 (13.04%)	0/21 (0.00%)	1/24 (4.17%)	3/6 (50.00%)	1/7 (14.29%)
Myalgia ^† 1	3/23 (13.04%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Muscular Weakness ^† 1	0/23 (0.00%)	1/21 (4.76%)	2/24 (8.33%)	0/6 (0.00%)	1/7 (14.29%)
Musculoskeletal Chest Pain ^† 1	2/23 (8.70%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Musculoskeletal Discomfort ^† 1	0/23 (0.00%)	2/21 (9.52%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Shoulder Pain ^† 1	2/23 (8.70%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Joint swelling	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	2/6 (33.33%)	0/7 (0.00%)
Musculoskeletal stiffness	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Skin neoplasm bleeding	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Squamous cell carcinoma	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Tumour necrosis	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Nervous system disorders
Headache ^† 1	4/23 (17.39%)	10/21 (47.62%)	8/24 (33.33%)	0/6 (0.00%)	3/7 (42.86%)
Dizziness ^† 1	1/23 (4.35%)	7/21 (33.33%)	7/24 (29.17%)	3/6 (50.00%)	2/7 (28.57%)
Dysgeusia ^† 1	2/23 (8.70%)	4/21 (19.05%)	2/24 (8.33%)	0/6 (0.00%)	2/7 (28.57%)
Hypoaesthesia ^† 1	0/23 (0.00%)	3/21 (14.29%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Neuropathy Peripheral ^† 1	0/23 (0.00%)	1/21 (4.76%)	2/24 (8.33%)	0/6 (0.00%)	1/7 (14.29%)
Paraesthesia ^† 1	0/23 (0.00%)	2/21 (9.52%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Balance disorder	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	3/6 (50.00%)	0/7 (0.00%)
Lethargy	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Peripheral sensory neuropathy	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	2/7 (28.57%)
Carpal tunnel syndrome	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Dizziness postural	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Multifocal motor neuropathy	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Sensory disturbance	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Psychiatric disorders
Anxiety ^† 1	2/23 (8.70%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	0/7 (0.00%)
Insomnia ^† 1	0/23 (0.00%)	0/21 (0.00%)	2/24 (8.33%)	0/6 (0.00%)	2/7 (28.57%)
Confusional state	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	2/6 (33.33%)	0/7 (0.00%)
Mental status changes	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	2/6 (33.33%)	0/7 (0.00%)
Renal and urinary disorders
Dysuria ^† 1	1/23 (4.35%)	0/21 (0.00%)	2/24 (8.33%)	0/6 (0.00%)	0/7 (0.00%)
Renal failure acute	2/23 (8.70%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Nocturia	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	9/23 (39.13%)	5/21 (23.81%)	7/24 (29.17%)	1/6 (16.67%)	2/7 (28.57%)
Dyspnoea ^† 1	5/23 (21.74%)	6/21 (28.57%)	9/24 (37.50%)	2/6 (33.33%)	2/7 (28.57%)
Sinus Congestion ^† 1	2/23 (8.70%)	3/21 (14.29%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Dyspnoea Exertional ^† 1	2/23 (8.70%)	2/21 (9.52%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Nasal Congestion ^† 1	0/23 (0.00%)	1/21 (4.76%)	2/24 (8.33%)	0/6 (0.00%)	0/7 (0.00%)
Pharyngolaryngeal Pain ^† 1	2/23 (8.70%)	0/21 (0.00%)	2/24 (8.33%)	0/6 (0.00%)	0/7 (0.00%)
Productive Cough ^† 1	2/23 (8.70%)	1/21 (4.76%)	1/24 (4.17%)	0/6 (0.00%)	0/7 (0.00%)
Rhinorrhoea ^† 1	1/23 (4.35%)	0/21 (0.00%)	2/24 (8.33%)	0/6 (0.00%)	1/7 (14.29%)
Epistaxis	1/23 (4.35%)	1/21 (4.76%)	1/24 (4.17%)	0/6 (0.00%)	1/7 (14.29%)
Rales	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Skin and subcutaneous tissue disorders
Night Sweats ^† 1	2/23 (8.70%)	3/21 (14.29%)	3/24 (12.50%)	0/6 (0.00%)	1/7 (14.29%)
Rash ^† 1	3/23 (13.04%)	2/21 (9.52%)	2/24 (8.33%)	1/6 (16.67%)	2/7 (28.57%)
Erythema	1/23 (4.35%)	1/21 (4.76%)	1/24 (4.17%)	1/6 (16.67%)	0/7 (0.00%)
Pruritus	0/23 (0.00%)	1/21 (4.76%)	1/24 (4.17%)	0/6 (0.00%)	1/7 (14.29%)
Alopecia	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Hyperhidrosis	0/23 (0.00%)	0/21 (0.00%)	1/24 (4.17%)	0/6 (0.00%)	1/7 (14.29%)
Petechiae	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Ecchymosis	0/23 (0.00%)	1/21 (4.76%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Photodermatosis	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Pruritus generalised	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Vascular disorders
Hypertension ^† 1	3/23 (13.04%)	10/21 (47.62%)	7/24 (29.17%)	0/6 (0.00%)	4/7 (57.14%)
Hypotension	1/23 (4.35%)	0/21 (0.00%)	1/24 (4.17%)	1/6 (16.67%)	0/7 (0.00%)
Orthostatic hypotension	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	2/7 (28.57%)
Subclavian vein thrombosis	1/23 (4.35%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
Pallor	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	0/6 (0.00%)	1/7 (14.29%)
Thrombosis	0/23 (0.00%)	0/21 (0.00%)	0/24 (0.00%)	1/6 (16.67%)	0/7 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 9.0

Limitations and Caveats

This is a small, non-randomized study. Comparisons between the 3 groups cannot be reliably made and should be interpreted with caution.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title: Anne-Marie Duliege, MD

Organization: Rigel

Phone: 650-624-1100

EMail: clinicaltrials@rigel.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Friedberg JW, Sharman J, Sweetenham J, Johnston PB, Vose JM, Lacasce A, Schaefer-Cutillo J, De Vos S, Sinha R, Leonard JP, Cripe LD, Gregory SA, Sterba MP, Lowe AM, Levy R, Shipp MA. Inhibition of Syk with fostamatinib disodium has significant clinical activity in non-Hodgkin lymphoma and chronic lymphocytic leukemia. Blood. 2010 Apr 1;115(13):2578-85. doi: 10.1182/blood-2009-08-236471. Epub 2009 Nov 17.

Responsible Party:	Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00446095 History of Changes
Other Study ID Numbers:	D4300C00023 C-935788-009 ( Other Identifier: Rigel Pharmaceuticals )
First Submitted:	March 8, 2007
First Posted:	March 12, 2007
Results First Submitted:	May 14, 2014
Results First Posted:	December 18, 2014
Last Update Posted:	September 19, 2016

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