Back to results

Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL

Primary Purpose

Follicular Lymphoma (FL/Indolent NHL), Aggressive NHL (a NHL), Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cerdulatinib

Rituximab

About this trial

This is an interventional treatment trial for Follicular Lymphoma (FL/Indolent NHL) focused on measuring Leukemia, Lymphocytic, Chronic, B Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Phase 1 Inclusion

• Participant at least 18 years of age with histologically confirmed CLL/SLL or B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma [DLBCL], FL, mantle cell lymphoma [MCL], marginal zone lymphoma [MZL], lymphoplasmacytic lymphoma).

Phase 2a Inclusion

Histological evidence: FL Grade 1-3A, with relapsed or refractory disease; aggressive NHL (aNHL), defined as DLBCL, FL Grade 3B, MCL, and transformed NHL with relapsed disease; CLL/SLL, peripheral T-cell lymphoma (PTCL), or cutaneous T-cell lymphoma (CTCL) (with mycosis fungoides [MF]/Sézary Syndrome [SS]) with relapsed or refractory disease
Received B-cell receptor (BCR) and/or BCL2 inhibitors and were intolerant or had relapsed/refractory disease afterwards
Prior treatment for lymphoid malignancy for progressive /refractory disease
≥1 prior regimen (minimum 2 cycles) with antibody conjugate/cytotoxic chemotherapy.
Measurable disease defined as: ≥1 lesion that measures ≥1.5 centimeter (cm) single dimension via computed tomography (CT), CT/positive-emission tomography (PET) with nodal or mass lesions; quantifiable circulating tumor cells; and for CTCL: Modified Severity Weighted Assessment Tool (mSWAT) >0
Ability to provide diagnostic reports

General Inclusion

Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1
Hematologic absolute neutrophil count (ANC) >1000/microliter (uL) and platelet >75,000/uL
Creatinine levels as specified by Investigator
Bilirubin <2.0 mg/deciliter [dL] (if Gilberts then <2.5 mg/dL) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <2.5*ULN

Exclusion Criteria:

Richter's syndrome, Burkitt's lymphoma, or Burkitt-like Lymphoma (transformed DLBCL from follicular NHL are eligible)
Prior transplant with stem cell infusion within 90 days of Day 1 or active graft-versus-host treatment within 8 weeks of Day 1
Prior therapy with Spleen Tyrosine Kinase (SYK) inhibitors
Chronic treatment with strong CYP3A4 inhibitor/inducer
Known lymphomatous involvement of the central nervous system (CNS)
Persistent, unresolved National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 ≥Grade 2, previous drug-related toxicity (except alopecia, erectile impotence, hot flashes, libido, neuropathy).
Prior monoclonal antibody (including alemtuzumab), radioimmunoconjugate, antibody drug conjugate, phototherapy, radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any test agent within 3 weeks of Day 1
For CTCL: (total skin electron beam therapy [TSEBT]) within 12 weeks, or initiation of topical steroid, nitrogen mustard, or topical retinoid within 2 weeks. Stable topical regimen for ≥4 weeks prior to Day 1 allowed.
Known carrier or infection for human immunodeficiency virus (HIV)/hepatitis B or C. If hepatitis C virus (HCV) antibody (ab)+, must be polymerase chain reaction (PCR)- to be eligible. If hepatitis B virus (HBV) ab+, must be hepatitis B surface antigen (HBsAg)- or undetectable HBV deoxyribonucleic acid (DNA) to be eligible.
Active infection requiring systemic treatment,
Significant gastrointestinal (GI) disease, previous major gastric/bowel surgery, difficulty swallowing, or malabsorption syndrome
Major surgery within 4 weeks
Previous malignancies within 2 years unless relapse risk is small (<5%).
Current use of systemic steroids >20 mg QD prednisone (or equivalent)
Breastfeeding or pregnant (intention to become) females or participation in other clinical trials

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Phase 1 Cerdulatinib

Phase 2a Cerdulatinib

Phase 2a Cerdulatinib plus Rituximab

Arm Description

During Phase 1, participants will receive oral cerdulatinib on Day 1 and then starting on Day 4 at doses of 15 mg up to 100 mg QD or oral cerdulatinib at doses of 15 mg up to 45 mg BID in 28-day cycles (except Cohort 1 will have a 21-day cycle starting on Day 1) for up to 10 cycles.

During Phase 2a, participants in cohorts based on cancer type will receive oral cerdulatinib at starting doses of 35, 30, or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib can be reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.

During Phase 2a, participants in this cohort will receive oral cerdulatinib at their applicable dose and an IV injection of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.

Outcomes

Primary Outcome Measures

Phase 1: Number of Participants With a Dose Limiting Toxicity (DLT)

DLT was defined as any of the following toxicities, possibly or probably related to cerdulatinib, and clinically significant (in the judgement of Investigator): -Febrile neutropenia (absolute neutrophil count <1000/microliter [μL] and temperature ≥38.5°Celcius). -Grade 4 neutropenia for >5 days. -Grade 4 thrombocytopenia with or without bleeding. -Grade 3 thrombocytopenia with bleeding. -Grade 4 anemia, unexplained by underlying disease. -Grade 3 or greater nausea, vomiting, or diarrhea if persistent despite optimal antiemetic or anti-diarrheal therapy. -Grade 3 or greater increase in transaminases lasting >5 days. -Grade 3 or greater fatigue persisting >7 days in absence of any other underlying cause. -Any other Grade 3 or greater non-hematologic toxicity (except fatigue as noted above) considered clinically significant by Investigator. -Toxicity of any grade resulting in dose delay of >7 days. -Toxicity resulting in study drug discontinuation prior to completion of Cycle 1.

Phase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator

CR included: -Via a positron emission tomography (PET)/computed tomography (CT) scan, score of 1 (no uptake above background), 2 (uptake of <mediastinum), or 3 (uptake of >mediastinum but <liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to <1.5 centimeters (cm) in longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative. PR included: -Via a PET/CT scan, score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, >50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites.

Secondary Outcome Measures

Phase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator

CR included: -Via a PET/CT scan, score of 1 (no uptake above background), 2 (uptake of <mediastinum), or 3 (uptake of >mediastinum but <liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of FDG-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to <1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative. PR included: -Via a PET/CT scan, a score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, >50% decrease in the sum of the product of perpendicular diameters for multiple lesion of up to 6 target measurable nodes and extranodal sites.

Phase 1: Number of Participants Achieving Clinical Benefit

Clinical benefit was defined as achieving stable disease (SD) or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, <50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.

Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)

An AE is any untoward medical occurrence, which may or may not have a causal relationship to the study drug, including: unfavorable and unintended sign, symptom, or disease temporally associated with the use of the study drug; any newly occurring event or exacerbation of previous condition (for example, increase in severity or frequency) since the administration of study drug; recurrence of an intermittent medical condition not present at baseline; any deterioration in a laboratory value or other clinical test that is associated with symptoms or leads to a change in study treatment or concomitant treatment or discontinuation from study drug; and AEs related to a study intervention. An SAE is an AE that is fatal, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or a congenital anomaly/birth defect.

Phase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of Cerdulatinib

Phase 2a: Median Time to Progression-Free Survival (PFS)

PFS=(first documentation of disease progression [DP] or death [whichever occurred first]-study drug first dose date+1)/30.4375 in months. PFS right censored for 1 of these conditions: 1) no baseline disease assessments; 2) starting new anticancer therapy before documented DP/death; 3) DP/death immediately after >6 months since last disease assessment (or >12 months if after last cycle); & alive without documented DP. 95% confidence interval estimated using Brookmeyer method. DP included: -Via a PET/CT scan, score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with uptake increase in intensity, new FDG-avid foci, & no nonmeasured lesions. -Via CT, abnormal individual node/lesion with significant LDi or shortest axis perpendicular to LDi increase; prior splenomegaly, >50% splenic length increase; if no prior splenomegaly, ≥2 cm splenic length increase; new or recurrent splenomegaly; new/clear progression of preexisting nonmeasured lesions.

Phase 2a: Number of Participants Achieving Clinical Benefit

Clinical benefit was defined as achieving SD or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, <50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.

Phase 2a: Number of Participants Achieving Dominant Mass Response (DMR)

DMR was defined as achieving a ≥50% decrease from baseline in the SPD of the target nodal and extranodal lesions. SPD at a visit was considered missing if any target lesion was not evaluated.

Full Information

NCT ID

NCT01994382

First Posted

November 8, 2013

Last Updated

April 1, 2022

Sponsor

Alexion

Collaborators

Portola Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01994382

Brief Title

Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL

Official Title

A Phase 1/2a Open-Label, Multi-Dose, Multi-Center Escalation and Exploratory Study of Cerdulatinib (PRT062070) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) or B-Cell or T-Cell Non-Hodgkin Lymphoma (NHL)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

August 30, 2013 (Actual)

Primary Completion Date

December 15, 2020 (Actual)

Study Completion Date

December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alexion

Collaborators

Portola Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070) that may be given in participants with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma.

Detailed Description

This is an open-label, Phase 1/2a, multi-dose, multi-center trial of orally administered cerdulatinib assessing safety, tolerability, and pharmacokinetic (PK) parameters conducted in 2 phases: Phase 1: Dose-escalation portion, during which participants will be enrolled to receive a single-agent cerdulatinib at their assigned dose level starting at 15 milligrams (mg) once daily (QD), administered in increasing doses until the maximum tolerated dose (MTD)/maximum administered dose (MAD) is identified. Phase 2a: Consisting of planned cohorts based on cancer type. The participants will receive single agent cerdulatinib at a starting dose of 35, 30, or 20 mg twice daily (BID) for 28-day cycles except for one of the cohorts, the participants will receive cerdulatinib plus intravenous (IV) rituximab at 375 mg/square meter (m^2) for 28-day cycles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Follicular Lymphoma (FL/Indolent NHL), Aggressive NHL (a NHL), Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL), T-cell Lymphoma (PTCL and CTCL), B-cell Non Hodgkin Lymphoma (NHL)

Keywords

Leukemia, Lymphocytic, Chronic, B Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1 Cerdulatinib

Arm Type

Experimental

Arm Description

Arm Title

Phase 2a Cerdulatinib

Arm Type

Experimental

Arm Description

Arm Title

Phase 2a Cerdulatinib plus Rituximab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cerdulatinib

Other Intervention Name(s)

PRT062070, ALXN2075

Intervention Description

Oral capsule

Intervention Type

Biological

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Rituxan®, Truxima®, Rixathon®, Ruxience®, MabThera®

Intervention Description

IV infusion

Primary Outcome Measure Information:

Title

Phase 1: Number of Participants With a Dose Limiting Toxicity (DLT)

Description

Time Frame

Baseline up to Day 28 of Cycle 1 (cycle = 21 days or 28 days)

Title

Phase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator

Description

Time Frame

Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])

Secondary Outcome Measure Information:

Title

Phase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator

Description

Time Frame

Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])

Title

Phase 1: Number of Participants Achieving Clinical Benefit

Description

Time Frame

Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])

Title

Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)

Description

Time Frame

Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])

Title

Phase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of Cerdulatinib

Time Frame

Cycle (C)1 Day (D)1: predose (0), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, and 72 hours postdose (except 15mg QD); C1D1: 0, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose (15mg QD); C2D1: 0, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose (all doses)

Title

Phase 2a: Median Time to Progression-Free Survival (PFS)

Description

Time Frame

Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])

Title

Phase 2a: Number of Participants Achieving Clinical Benefit

Description

Time Frame

Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])

Title

Phase 2a: Number of Participants Achieving Dominant Mass Response (DMR)

Description

DMR was defined as achieving a ≥50% decrease from baseline in the SPD of the target nodal and extranodal lesions. SPD at a visit was considered missing if any target lesion was not evaluated.

Time Frame

Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Phase 1 Inclusion • Participant at least 18 years of age with histologically confirmed CLL/SLL or B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma [DLBCL], FL, mantle cell lymphoma [MCL], marginal zone lymphoma [MZL], lymphoplasmacytic lymphoma). Phase 2a Inclusion Histological evidence: FL Grade 1-3A, with relapsed or refractory disease; aggressive NHL (aNHL), defined as DLBCL, FL Grade 3B, MCL, and transformed NHL with relapsed disease; CLL/SLL, peripheral T-cell lymphoma (PTCL), or cutaneous T-cell lymphoma (CTCL) (with mycosis fungoides [MF]/Sézary Syndrome [SS]) with relapsed or refractory disease Received B-cell receptor (BCR) and/or BCL2 inhibitors and were intolerant or had relapsed/refractory disease afterwards Prior treatment for lymphoid malignancy for progressive /refractory disease ≥1 prior regimen (minimum 2 cycles) with antibody conjugate/cytotoxic chemotherapy. Measurable disease defined as: ≥1 lesion that measures ≥1.5 centimeter (cm) single dimension via computed tomography (CT), CT/positive-emission tomography (PET) with nodal or mass lesions; quantifiable circulating tumor cells; and for CTCL: Modified Severity Weighted Assessment Tool (mSWAT) >0 Ability to provide diagnostic reports General Inclusion Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1 Hematologic absolute neutrophil count (ANC) >1000/microliter (uL) and platelet >75,000/uL Creatinine levels as specified by Investigator Bilirubin <2.0 mg/deciliter [dL] (if Gilberts then <2.5 mg/dL) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <2.5*ULN Exclusion Criteria: Richter's syndrome, Burkitt's lymphoma, or Burkitt-like Lymphoma (transformed DLBCL from follicular NHL are eligible) Prior transplant with stem cell infusion within 90 days of Day 1 or active graft-versus-host treatment within 8 weeks of Day 1 Prior therapy with Spleen Tyrosine Kinase (SYK) inhibitors Chronic treatment with strong CYP3A4 inhibitor/inducer Known lymphomatous involvement of the central nervous system (CNS) Persistent, unresolved National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 ≥Grade 2, previous drug-related toxicity (except alopecia, erectile impotence, hot flashes, libido, neuropathy). Prior monoclonal antibody (including alemtuzumab), radioimmunoconjugate, antibody drug conjugate, phototherapy, radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any test agent within 3 weeks of Day 1 For CTCL: (total skin electron beam therapy [TSEBT]) within 12 weeks, or initiation of topical steroid, nitrogen mustard, or topical retinoid within 2 weeks. Stable topical regimen for ≥4 weeks prior to Day 1 allowed. Known carrier or infection for human immunodeficiency virus (HIV)/hepatitis B or C. If hepatitis C virus (HCV) antibody (ab)+, must be polymerase chain reaction (PCR)- to be eligible. If hepatitis B virus (HBV) ab+, must be hepatitis B surface antigen (HBsAg)- or undetectable HBV deoxyribonucleic acid (DNA) to be eligible. Active infection requiring systemic treatment, Significant gastrointestinal (GI) disease, previous major gastric/bowel surgery, difficulty swallowing, or malabsorption syndrome Major surgery within 4 weeks Previous malignancies within 2 years unless relapse risk is small (<5%). Current use of systemic steroids >20 mg QD prednisone (or equivalent) Breastfeeding or pregnant (intention to become) females or participation in other clinical trials

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Portola Study Director

Organizational Affiliation

Portola Pharmaceuticals

Official's Role

Study Director

Facility Information:

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35805

Country

United States

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34232

Country

United States

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39402

Country

United States

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07960

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29412

Country

United States

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23226

Country

United States

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Citations:

Citation

Paul A. Hamlin, Manish R. Patel, Don Stevens, Brian T. Hess, Javier Munoz, Tatyana A. Feldman, Sonali M. Smith, Greg P. Coffey, Muhtarjan Osman, Jaymes S Holland, Cristina B Guzman, Stephen D. Smith; Phase 2a Study of the Dual SYK/JAK Inhibitor Cerdulatinib (ALXN2075) As Monotherapy or in Combination with Rituximab in Patients with Relapsed/Refractory Follicular Lymphoma. Blood 2021; 138 (Supplement 1): 2423. doi: https://doi.org/10.1182/blood-2021-148313

Results Reference

result

PubMed Identifier

30333224

Citation

Coffey GP, Feng J, Betz A, Pandey A, Birrell M, Leeds JM, Der K, Kadri S, Lu P, Segal J, Wang YL, Michelson G, Curnutte JT, Conley PB. Cerdulatinib Pharmacodynamics and Relationships to Tumor Response Following Oral Dosing in Patients with Relapsed/Refractory B-cell Malignancies. Clin Cancer Res. 2019 Feb 15;25(4):1174-1184. doi: 10.1158/1078-0432.CCR-18-1047. Epub 2018 Oct 17.

Results Reference

derived

Learn more about this trial

Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL

We'll reach out to this number within 24 hrs