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

NCT02662296 | Withdrawn Phase 2 DMC

• 4 other identifiers: 2561.00NCI-2015-02201P01CA018029P30CA015704
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well ibrutinib or idelalisib works in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that is persistent or has returned (relapsed) after donor stem cell transplant. Ibrutinib and idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Conditions

Prolymphocytic Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Non-Hodgkin Lymphoma; Recurrent Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS) (Cohort I)

  OS will be estimated using the Kaplan-Meier method.

  12 months

Secondary Outcomes (3)

• Incidence of grade III-IV adverse events using the National Cancer Institute Common Toxicity Criteria version 4.0 (Cohort I and Cohort II)

  Up to 30 days post-treatment

• OS (Cohort I and Cohort II)

  Up to 6 years

• Progression free-survival (PFS) (Cohort I and Cohort II)

  Up to 6 years

Study Arms (1)

Treatment (ibrutinib or idelalisib)

EXPERIMENTAL

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.

Drug: Ibrutinib; Drug: Idelalisib

Interventions

Ibrutinib DRUG

Given PO

Also known as: BTK Inhibitor PCI-32765, CRA-032765, PCI-32765

Treatment (ibrutinib or idelalisib)

Idelalisib DRUG

Given PO

Also known as: CAL-101, GS-1101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig

Treatment (ibrutinib or idelalisib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Prolymphocytic; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin

Interventions

ibrutinib; idelalisib

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Study Officials

• Mohamed Sorror

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 25, 2016
• Study Start: March 1, 2016
• Primary Completion: February 1, 2022
• Last Updated: September 27, 2017

Record last verified: 2017-09

Locations

US (1)