A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

• Sponsor: SecuraBio (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02391545
• Collaborator: (none)
• Enrollment: 55
• Locations: 21
• Arms: 2
• Duration (Months): 29
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.

Condition or Disease	Intervention/Treatment	Phase
CD20+ Follicular Lymphoma	Drug: Duvelisib; Drug: Rituximab; Drug: Obinutuzumab	Phase 1/Phase 2

Detailed Description

This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in subjects with previously untreated CD20+ FL.

The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized, 2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting toxicity (DLT) within Part 1.

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Jan 17, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Duvelisib and Rituximab Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.	Drug: Duvelisib; PI3K Inhibitor; Other Names: Copiktra, IPI-145 ; Drug: Rituximab; monoclonal antibody; Other Names: Rituxan/MabThera®
Experimental: Duvelisib and Obinutuzumab Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.	Drug: Duvelisib; PI3K Inhibitor; Other Names: Copiktra, IPI-145 ; Drug: Obinutuzumab; monoclonal antibody; Other Names: GAZYVA/GAZYVARO™

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1 [28 days from first dose of study treatment]

2. Complete Response Rate (CRR)- Part 2 [Up to 2 years from the first dose of study treatment]

Secondary Outcome Measures

1. Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values [Up to 30 days after the last dose of study treatment]

   Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as >=Grade 3.

2. Overall Response Rate (ORR) [Up to 2 years from the first dose of study treatment]

3. Duration of Response (DOR) [Up to 2 years from the first dose of study treatment]

   The median DOR was non-estimable.

4. Overall Survival (OS) [Up to 2 years from the first dose of study treatment]

5. Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite) [Every 4 weeks for 16 weeks]

   Plasma concentrations of Duvelisib and IPI-656 (metabolite)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of CD20+, follicular lymphoma that has not been treated

• CD20-immunophenotyping of tumor to document B-cell follicular lymphoma

• Stage II disease with bulky disease (≥ 7cm lesion), Stage III, or Stage IV disease

• Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF criteria)

• At least one measurable lesion that is > 1.5 cm in at least one dimension

• Eastern Cooperative Oncology Group (ECOG) performance status <=2 (corresponds to Karnofsky Performance Status [KPS] >=60%)

Exclusion Criteria:

• Received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy.

• Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B follicular lymphoma

• Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs

• Prior allogeneic hematopoietic stem cell transplant

• Prior, current or chronic hepatitis B or hepatitis C infection

• Human immunodeficiency virus (HIV) infection or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Los Angeles	California	United States	90095
2		Palo Alto	California	United States	94304
3		Hackensack	New Jersey	United States	07601
4		Rochester	New York	United States	14642
5		Dallas	Texas	United States	75246
6		Kortrijk		Belgium	8000
7		Leuven		Belgium	3000
8		Wilrijk		Belgium	2610
9		Clermont-Ferrand		France	63003
10		Marseille Cedex 05		France	13385
11		Pessac		France	33600
12		Rouen Cedex 1		France	76038
13		Tours Cedex 01		France	37044
14		Bologna		Italy	40138
15		Varese		Italy	21100
16		Badalona	Barcelona	Spain	8916
17		Barcelona		Spain	8097
18		Madrid		Spain	28222
19		Salamanca		Spain	37007
20		Leeds		United Kingdom	LS9 7TF
21		London		United Kingdom	NW1 1BU

Sponsors and Collaborators

• SecuraBio

Investigators

• Study Chair: Hagop Youssoufian, MD, Verastem, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SecuraBio
• ClinicalTrials.gov Identifier: NCT02391545
• Other Study ID Numbers: IPI-145-19
• First Posted: Mar 18, 2015
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by SecuraBio: Follicular Lymphoma; Previously Untreated
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Follicular; Rituximab; Obinutuzumab

Study Results

Participant Flow

Arm/Group Title	Duvelisib and Obinutuzumab	Duvelisib and Rituximab
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. IPI-145 (duvelisib): PI3K Inhibitor Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. IPI-145 (duvelisib): PI3K Inhibitor Rituximab
Period Title: Overall Study
STARTED	27	28
COMPLETED	1	0
NOT COMPLETED	26	28

Baseline Characteristics

Arm/Group Title	Duvelisib and Obinutuzumab	Duvelisib and Rituximab	Total
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. IPI-145 (duvelisib): PI3K Inhibitor Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. IPI-145 (duvelisib): PI3K Inhibitor Rituximab	Total of all reporting groups
Overall Participants	27	28	55
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 59.3%	20 71.4%	36 65.5%
>=65 years	11 40.7%	8 28.6%	19 34.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.4 (12.32)	58.2 (10.65)	58.3 (11.39)
Sex: Female, Male (Count of Participants)
Female	16 59.3%	10 35.7%	26 47.3%
Male	11 40.7%	18 64.3%	29 52.7%
Region of Enrollment (participants) [Number]
Belgium	6 22.2%	3 10.7%	9 16.4%
United States	10 37%	9 32.1%	19 34.5%
United Kingdom	3 11.1%	2 7.1%	5 9.1%
Italy	1 3.7%	1 3.6%	2 3.6%
France	3 11.1%	4 14.3%	7 12.7%
Spain	4 14.8%	9 32.1%	13 23.6%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
Time Frame	28 days from first dose of study treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duvelisib and Obinutuzumab	Duvelisib and Rituximab
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. IPI-145 will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab
Measure Participants	27	28
Count of Participants [Participants]	1 3.7%	0 0%

2. Primary Outcome

Title	Complete Response Rate (CRR)- Part 2
Time Frame	Up to 2 years from the first dose of study treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duvelisib and Obinutuzumab	Duvelisib and Rituximab
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. IPI-145 will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab
Measure Participants	27	28
Count of Participants [Participants]	11 40.7%	10 35.7%

3. Secondary Outcome

Title	Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
Description	Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as >=Grade 3.
Time Frame	Up to 30 days after the last dose of study treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duvelisib and Obinutuzumab	Duvelisib and Rituximab
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab
Measure Participants	27	28
TEAEs assessed as ≥ Grade 3	24 88.9%	19 67.9%
TEAEs ≥ Grade 3 assessed as related to duvelisib	23 85.2%	17 60.7%
TEAEs ≥ Grade 3 assessed as related to anti-CD20	11 40.7%	2 7.1%

4. Secondary Outcome

Title	Overall Response Rate (ORR)
Time Frame	Up to 2 years from the first dose of study treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duvelisib and Obinutuzumab	Duvelisib and Rituximab
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab
Measure Participants	27	28
Complete Response	11 40.7%	10 35.7%
Partial Response	13 48.1%	16 57.1%
Stable Disease	1 3.7%	0 0%

5. Secondary Outcome

Title	Duration of Response (DOR)
Description	The median DOR was non-estimable.
Time Frame	Up to 2 years from the first dose of study treatment

Outcome Measure Data

Analysis Population Description

Data could not be reported because the study was terminated early and a sufficient number of subjects and events were not available for analysis.

Arm/Group Title	Duvelisib and Obinutuzumab	Duvelisib and Rituximab
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab
Measure Participants	0	0

6. Secondary Outcome

Title	Overall Survival (OS)
Time Frame	Up to 2 years from the first dose of study treatment

Outcome Measure Data

Analysis Population Description

The study had been terminated and Overall Survival was not performed.

Arm/Group Title	Duvelisib and Obinutuzumab	Duvelisib and Rituximab
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab
Measure Participants	0	0

7. Secondary Outcome

Title	Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)
Description	Plasma concentrations of Duvelisib and IPI-656 (metabolite)
Time Frame	Every 4 weeks for 16 weeks

Outcome Measure Data

Analysis Population Description

The study had been terminated and PK analysis was not performed.

Arm/Group Title	Duvelisib and Obinutuzumab	Duvelisib and Rituximab
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Obinutuzumab	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. Duvelisib: PI3K Inhibitor Rituximab
Measure Participants	0	0

Adverse Events

Time Frame	35 months
Arm/Group Title	Duvelisib and Obinutuzumab		Duvelisib and Rituximab
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. IPI-145 (duvelisib): PI3K Inhibitor Obinutuzumab		Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. IPI-145 (duvelisib): PI3K Inhibitor Rituximab
All Cause Mortality
	Duvelisib and Obinutuzumab		Duvelisib and Rituximab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		1/28 (3.6%)
Serious Adverse Events
	Duvelisib and Obinutuzumab		Duvelisib and Rituximab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/27 (59.3%)		10/28 (35.7%)
Blood and lymphatic system disorders
Febrile Neutropenia	1/27 (3.7%)		0/28 (0%)
Gastrointestinal disorders
Colitis	2/27 (7.4%)		1/28 (3.6%)
Diarrhoea	2/27 (7.4%)		4/28 (14.3%)
Odynophagia	1/27 (3.7%)		0/28 (0%)
Stomatitis	1/27 (3.7%)		0/28 (0%)
Nausea	0/27 (0%)		1/28 (3.6%)
Vomiting	0/27 (0%)		1/28 (3.6%)
General disorders
Pyrexia	4/27 (14.8%)		2/28 (7.1%)
Fatigue	1/27 (3.7%)		0/28 (0%)
Mucosal Inflammation	1/27 (3.7%)		0/28 (0%)
Hepatobiliary disorders
Hepatotoxicity	1/27 (3.7%)		0/28 (0%)
Hepatitis	0/27 (0%)		1/28 (3.6%)
Infections and infestations
Conjuctivitis	1/27 (3.7%)		0/28 (0%)
Diarrhoea infectious	1/27 (3.7%)		0/28 (0%)
Klebsiella infection	1/27 (3.7%)		0/28 (0%)
Pneumonia	1/27 (3.7%)		0/28 (0%)
Pneumonia respiratory synctial viral	1/27 (3.7%)		0/28 (0%)
Pylonephritis	1/27 (3.7%)		0/28 (0%)
Septic Shock	1/27 (3.7%)		0/28 (0%)
Cytomegalovirus infection	0/27 (0%)		1/28 (3.6%)
Pneumocystis jirovecii infection	0/27 (0%)		1/28 (3.6%)
Pneumocystis jirovecii pneumonia	0/27 (0%)		1/28 (3.6%)
Pneumonia Cytomegaloviral	0/27 (0%)		1/28 (3.6%)
Pneumonia pneumococcal	0/27 (0%)		1/28 (3.6%)
Injury, poisoning and procedural complications
Infusion related reaction	1/27 (3.7%)		0/28 (0%)
Investigations
Alanine aminotransferase increased	2/27 (7.4%)		0/28 (0%)
Aspartate aminotransferase increased	1/27 (3.7%)		0/28 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/27 (0%)		1/28 (3.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma	0/27 (0%)		1/28 (3.6%)
Squamous cell carcinoma of skin	0/27 (0%)		1/28 (3.6%)
Nervous system disorders
Syncope	1/27 (3.7%)		0/28 (0%)
Renal and urinary disorders
Renal Failure	1/27 (3.7%)		0/28 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/27 (3.7%)		1/28 (3.6%)
Pneumonitis	1/27 (3.7%)		0/28 (0%)
Skin and subcutaneous tissue disorders
Rash	2/27 (7.4%)		1/28 (3.6%)
Rash papular	1/27 (3.7%)		0/28 (0%)
Rash generalised	0/27 (0%)		1/28 (3.6%)
Vascular disorders
Embolism	0/27 (0%)		1/28 (3.6%)
Other (Not Including Serious) Adverse Events
	Duvelisib and Obinutuzumab		Duvelisib and Rituximab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/27 (96.3%)		27/28 (96.4%)
Blood and lymphatic system disorders
Neutropenia	5/27 (18.5%)		4/28 (14.3%)
Anaemia	1/27 (3.7%)		2/28 (7.1%)
Thrombocytopenia	1/27 (3.7%)		2/28 (7.1%)
Ear and labyrinth disorders
Vertigo	2/27 (7.4%)		0/28 (0%)
Gastrointestinal disorders
Nausea	12/27 (44.4%)		7/28 (25%)
Diarrhoea	11/27 (40.7%)		16/28 (57.1%)
Abdominal Pain	8/27 (29.6%)		5/28 (17.9%)
Vomiting	8/27 (29.6%)		3/28 (10.7%)
Abdominal pain upper	5/27 (18.5%)		2/28 (7.1%)
Constipation	4/27 (14.8%)		5/28 (17.9%)
Stomatitis	4/27 (14.8%)		1/28 (3.6%)
Gastrooesophageal reflux disease	3/27 (11.1%)		3/28 (10.7%)
Dyspepsia	2/27 (7.4%)		0/28 (0%)
Toothache	2/27 (7.4%)		0/28 (0%)
Colitis	0/27 (0%)		2/28 (7.1%)
General disorders
Fatigue	8/27 (29.6%)		9/28 (32.1%)
Pyrexia	8/27 (29.6%)		6/28 (21.4%)
Asthenia	4/27 (14.8%)		5/28 (17.9%)
Malaise	4/27 (14.8%)		1/28 (3.6%)
Mucosal Inflammation	2/27 (7.4%)		3/28 (10.7%)
Chills	1/27 (3.7%)		2/28 (7.1%)
Immune system disorders
Drug Hypersensitivity	2/27 (7.4%)		0/28 (0%)
Infections and infestations
Nasopharyngitis	6/27 (22.2%)		1/28 (3.6%)
Conjuctivitis	4/27 (14.8%)		1/28 (3.6%)
Sinusitis	2/27 (7.4%)		1/28 (3.6%)
Upper respiratory tract infection	2/27 (7.4%)		2/28 (7.1%)
Injury, poisoning and procedural complications
Infusion related reaction	3/27 (11.1%)		1/28 (3.6%)
Investigations
Alanine aminotransferase increased	13/27 (48.1%)		9/28 (32.1%)
Aspartate aminotransferase increased	13/27 (48.1%)		8/28 (28.6%)
Amylase increased	3/27 (11.1%)		3/28 (10.7%)
Lipase increased	3/27 (11.1%)		3/28 (10.7%)
Transaminases increased	1/27 (3.7%)		3/28 (10.7%)
Metabolism and nutrition disorders
Decreased appetite	6/27 (22.2%)		0/28 (0%)
Hypokalaemia	3/27 (11.1%)		1/28 (3.6%)
Hypomagnesaemia	2/27 (7.4%)		0/28 (0%)
Hypophosphataemia	2/27 (7.4%)		0/28 (0%)
Musculoskeletal and connective tissue disorders
Back pain	3/27 (11.1%)		6/28 (21.4%)
Arthralgia	2/27 (7.4%)		1/28 (3.6%)
Muscle spasms	2/27 (7.4%)		0/28 (0%)
Muscular Weakness	0/27 (0%)		2/28 (7.1%)
Musculoskeletal discomfort	0/27 (0%)		2/28 (7.1%)
Myalgia	0/27 (0%)		3/28 (10.7%)
Nervous system disorders
Dysgeusia	4/27 (14.8%)		1/28 (3.6%)
Headache	4/27 (14.8%)		4/28 (14.3%)
Dizziness	2/27 (7.4%)		1/28 (3.6%)
Psychiatric disorders
Anxiety	3/27 (11.1%)		5/28 (17.9%)
Depression	2/27 (7.4%)		1/28 (3.6%)
Insomnia	1/27 (3.7%)		2/28 (7.1%)
Renal and urinary disorders
Pollakiuria	0/27 (0%)		2/28 (7.1%)
Respiratory, thoracic and mediastinal disorders
Cough	6/27 (22.2%)		7/28 (25%)
Oropharyngeal pain	4/27 (14.8%)		2/28 (7.1%)
Dyspnoea	2/27 (7.4%)		4/28 (14.3%)
Rhinorrhoea	2/27 (7.4%)		0/28 (0%)
Productive Cough	1/27 (3.7%)		2/28 (7.1%)
Skin and subcutaneous tissue disorders
Rash	7/27 (25.9%)		7/28 (25%)
Dry Skin	3/27 (11.1%)		2/28 (7.1%)
Alopecia	2/27 (7.4%)		1/28 (3.6%)
Rash erythematous	2/27 (7.4%)		1/28 (3.6%)
Erythema	1/27 (3.7%)		2/28 (7.1%)
Pruritis	1/27 (3.7%)		3/28 (10.7%)
Rash generalised	0/27 (0%)		2/28 (7.1%)
Vascular disorders
Orthostatic Hypotension	1/27 (3.7%)		2/28 (7.1%)
Hypertension	0/27 (0%)		3/28 (10.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.