- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02662296
Ibrutinib or Idelalisib in Treating Patients With Persistent or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma After Donor Stem Cell Transplant
A Phase II, Non-Randomized, Single Institution, Clinical Trial of Signal Transduction Inhibitors, Ibrutinib or Idelalisib, to Treat Patients With Persistent or Relapsed B-Cell Malignancies Following Allogeneic Hematopoietic Cell Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To improve the outcomes of patients who have progressed or relapsed lymphoma or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)/prolymphocytic leukemia (PLL) within 180 days following allogeneic hematopoietic cell transplant (HCT) compared to historical data: 12-month overall survival.
SECONDARY OBJECTIVES:
I. To describe the safety profile observed in these populations.
II. Estimate the overall response rate (complete response [CR] + partial response [PR]) by standard morphologic, flow cytometric, imaging, and molecular techniques.
III. Assess progression free-survival.
IV. Define incidences of grade III-IV toxicities and infections.
V. Estimate incidence of relapse and non-relapse mortality.
VI. Estimate incidences of grade II-III and III-IV acute graft-versus-host disease (GVHD) and chronic GVHD.
OUTLINE:
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28 or idelalisib PO twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with diagnoses of CLL/SLL or non-Hodgkin lymphoma (NHL) patients, who meet the criteria of either relapse or progression at any time point after allogeneic HCT or those who experience persistent stable disease or persistent disease with regression between days 28 and 100 post-transplant using standard morphologic, flow cytometric, and/or imaging studies and following the disease response evaluation criteria established by the International Workshop on CLL (IWCLL) for CLL and those following Cheson 2007 criteria for NHL
Patients will then be assigned to one of two cohorts:
- Cohort 1 will include patients who have relapsed /progressed within the first 180 days post-transplant and who are still within 3 months from date of progression-relapse
Cohort 2 will include patients who have either i) relapsed/progressed beyond day 180 post-HCT, ii) those with persistent stable disease or persistent disease with regression between days 28-100 after allogeneic HCT, or iii) those who progressed or relapsed within 180 days after HCT but were not started on this protocol within 3 months from date of progression or relapse could also be enrolled under cohort 2
- NOTE: the inclusion of patients with persistent stable or persistent regressing disease in this protocol is not meant to advocate treatment; however, if the attending physician is inclined to offer treatment then these patients would be eligible for this study
- Patients must be able to give informed consent
- Women of childbearing potential and men who are sexually active must affirm they are practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during or after the study; for females, these restrictions apply for 1 month after the last dose of study drug; for males, these restrictions apply for 3 months after the last dose of the study drug
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [B-hCG]) or urine pregnancy test at screening
- Absolute neutrophil count (ANC) >= 750/mm^3
- Platelets >= 30,000/mm^3
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
- Total bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
- Creatinine clearance (Clcr) > 25 mL/min
Exclusion Criteria:
- Pregnant or breast feeding females; (lactating females must agree not to breast feed while taking ibrutinib or idelalisib)
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study should be first discussed and clarified with the study investigators
- Concurrent use of other anti-cancer agents or treatments
- Known history of human immunodeficiency virus (HIV)
- Karnofsky performance status < 50%
- Active grades III or IV acute GVHD
- Central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy
- Vaccinated with live, attenuated vaccines within 4 weeks of initiation of therapy
- Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol principal investigators
- Unable to swallow capsules or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; malabsorption syndrome, resection of the small bowel, or poorly controlled inflammatory bowel disease affecting the small intestine
- Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- Have uncontrolled hepatitis B or C infection
- IBRUTINIB-SPECIFIC EXCLUSION CRITERIA
- History of stroke or intracranial hemorrhage within 6 months of screening would be exclusion for ibrutinib therapy but idelalisib would be an option
- Patients requiring anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 28 days from the start of study drug cannot be treated with ibrutinib but idelalisib would be an option
- Patients requiring chronic treatment with strong cytochrome P450 family 3, subfamily A (CYP3A) inhibitors cannot be treated with ibrutinib but idelalisib would be an option
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification would be exclusion for ibrutinib therapy but idelalisib would be an option
- IDELALISIB-SPECIFIC EXCLUSION CRITERIA
- Ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension would be exclusion for idelalisib therapy but ibrutinib would be an option
- Ongoing drug-induced pneumonitis would be exclusion for idelalisib therapy but ibrutinib would be an option
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment (ibrutinib or idelalisib)
Patients receive ibrutinib PO QD on days 1-28 or idelalisib PO BID on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Given PO
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS) (Cohort I)
Time Frame: 12 months
|
OS will be estimated using the Kaplan-Meier method.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of grade III-IV adverse events using the National Cancer Institute Common Toxicity Criteria version 4.0 (Cohort I and Cohort II)
Time Frame: Up to 30 days post-treatment
|
Toxicities among the 2 cohorts will be compared to those reported in the literature after using ibrutinib or idelalisib for relapsed CLL/lymphoma before transplant.
|
Up to 30 days post-treatment
|
OS (Cohort I and Cohort II)
Time Frame: Up to 6 years
|
OS will be estimated using the Kaplan-Meier method in all cohorts.
|
Up to 6 years
|
Progression free-survival (PFS) (Cohort I and Cohort II)
Time Frame: Up to 6 years
|
PFS will be estimated using the Kaplan-Meier method in all cohorts.
|
Up to 6 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Leukemia, B-Cell
- Lymphoma
- Leukemia
- Recurrence
- Lymphoma, Non-Hodgkin
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Leukemia, Prolymphocytic
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Idelalisib
Other Study ID Numbers
- 2561.00 (OTHER: Fred Hutch/University of Washington Cancer Consortium)
- P30CA015704 (U.S. NIH Grant/Contract)
- P01CA018029 (U.S. NIH Grant/Contract)
- NCI-2015-02201 (REGISTRY: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Small Lymphocytic Lymphoma
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingRecurrent Small Lymphocytic Lymphoma | Refractory Chronic Lymphocytic Leukemia | Recurrent Chronic Lymphocytic Leukemia | Refractory Small Lymphocytic Lymphoma | Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaUnited States
-
Fred Hutchinson Cancer CenterAstraZenecaRecruitingRecurrent Small Lymphocytic Lymphoma | Refractory Chronic Lymphocytic Leukemia | Recurrent Chronic Lymphocytic Leukemia | Refractory Small Lymphocytic LymphomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Small Lymphocytic Lymphoma | Refractory Chronic Lymphocytic Leukemia | Recurrent Chronic Lymphocytic Leukemia | Refractory Small Lymphocytic LymphomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Small Lymphocytic Lymphoma | Refractory Chronic Lymphocytic Leukemia | Recurrent Chronic Lymphocytic Leukemia | Refractory Small Lymphocytic LymphomaUnited States
-
Steven E. CoutreCompletedRecurrent Small Lymphocytic Lymphoma | Refractory Chronic Lymphocytic Leukemia | Recurrent Chronic Lymphocytic Leukemia | Refractory Small Lymphocytic LymphomaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingChronic Lymphocytic Leukemia | Recurrent Small Lymphocytic Lymphoma | Refractory Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | Recurrent Chronic Lymphocytic Leukemia | Refractory Small Lymphocytic LymphomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Small Lymphocytic Lymphoma | Refractory Chronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Noncontiguous Stage II Small Lymphocytic LymphomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Small Lymphocytic Lymphoma | Refractory Chronic Lymphocytic Leukemia | Recurrent Chronic Lymphocytic Leukemia | Refractory Small Lymphocytic LymphomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Grade 3 Follicular Lymphoma | Recurrent Marginal Zone Lymphoma | Recurrent Small Lymphocytic Lymphoma | Refractory Small Lymphocytic Lymphoma | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Refractory... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Adult Acute Myeloid Leukemia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Marginal Zone Lymphoma | Splenic Marginal Zone Lymphoma | Recurrent Adult Acute Lymphoblastic Leukemia | Recurrent Small Lymphocytic... and other conditionsUnited States
Clinical Trials on Ibrutinib
-
Christian BuskeAmgen; Janssen, LPRecruitingWaldenstrom MacroglobulinemiaAustria, Germany, Greece
-
TG Therapeutics, Inc.CompletedMantle Cell Lymphoma | Chronic Lymphocytic LeukemiaUnited States
-
Johnson & Johnson Private LimitedCompletedLymphoma, Mantle-Cell | Leukemia, Lymphocytic, Chronic, B-CellIndia
-
Janssen Research & Development, LLCCompleted
-
Janssen Research & Development, LLCCompleted
-
Oncternal Therapeutics, IncUniversity of California, San Diego; Pharmacyclics LLC.; California Institute...Active, not recruitingMantle Cell Lymphoma | Marginal Zone Lymphoma | B-cell Chronic Lymphocytic Leukemia | Small Lymphocytic LymphomaUnited States
-
The Lymphoma Academic Research OrganisationJanssen Pharmaceutica N.V., BelgiumTerminatedB-cell LymphomaFrance, Belgium
-
Pharmacyclics Switzerland GmbHJanssen Biotech, Inc., including Johnson & JohnsonEnrolling by invitationLymphoma, B-Cell | Lymphoma, Non-Hodgkin | Solid Tumor | Leukemia, B-cell | Graft Vs Host DiseaseUnited States, Spain, Taiwan, United Kingdom, Australia, Italy, Russian Federation, Canada, New Zealand, Korea, Republic of, France, Turkey, Czechia, Hungary, Poland, Sweden
-
Janssen-Cilag Ltd.CompletedLymphoma, Mantle-Cell | Leukemia, Lymphocytic, Chronic, B-CellFrance
-
The Lymphoma Academic Research OrganisationCompletedIntraocular Lymphoma | Primary Central Nervous LymphomaFrance