Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

NCT01719250 | Completed Early Phase 1

• 3 other identifiers: MC1183NCI-2012-01582P30CA015083
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies how well buparlisib works in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment. Buparlisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Conditions

Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma; Transformed Recurrent Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Clinical benefit defined as a PR or CR as the objective status at any time or an objective status of SD for a duration of greater than 6 months from registration

  The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent binomial confidence intervals for the true success proportion will be calculated.

  From 6 months from registration up to 1 year

Secondary Outcomes (5)

• Duration of response

  From the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented, assessed up to 1 year

• Overall response rate estimated by the number of confirmed responses (PR or CR) observed in the trial divided by the total number of evaluable patients

  Up to 1 year

• Prognostic factors for aggressive lymphoma

  Up to 1 year

• Progression-free survival time

  Time from registration to progression or death due to any cause, assessed up to 1 year

• Survival time

  Time from registration to death due to any cause, assessed up to 1 year

Study Arms (1)

Treatment (buparlisib)

EXPERIMENTAL

Patients receive buparlisib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Buparlisib; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Interventions

Buparlisib DRUG

Given PO

Also known as: BKM120, PI3K Inhibitor BKM120

Treatment (buparlisib)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (buparlisib)

Questionnaire Administration OTHER

Ancillary studies

Treatment (buparlisib)

Eligibility Criteria

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

You may qualify if:

• Biopsy-proven relapsed, refractory or residual aggressive B-cell non-Hodgkin lymphoma; NOTE: re-biopsy is necessary unless the patient has had a previous biopsy \< 168 days prior to registration on this protocol and there has been no intervening treatment; eligible tumor types are diffuse large B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma, transformed NHL, and follicular grade III
• Not a candidate or has declined standard salvage therapy for their disease
• Measurable disease as defined by at least ONE of the following:
• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) or the CT portion of the positron emission tomography (PET)/CT: must have at least one lesion that has a single diameter of \>= 2 cm or tumor cells in the blood \>= 5 x 10\^9/L
• Skin lesions can be used if the area is \>= 2 cm in at least one diameter and photographed with a ruler
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
• Absolute neutrophil count (ANC) \>= 1000/uL
• Hemoglobin (Hgb) \>= 9 g/dl
• Platelets (PLT) \>= 100,000/uL
• Serum bilirubin within normal range (or =\< 1.5 x upper limit of normal \[ULN\] if liver metastases are present; or total bilirubin =\< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
• Aspartate aminotransferase (AST) within normal limits or =\< 3 x ULN if due to lymphoma
• Serum creatinine =\< 1.5 x ULN or 24-hour clearance \>= 50 mL/min
• Magnesium \>= lower limit of normal (LLN)
• Potassium \>= LLN
• Serum amylase =\< ULN

You may not qualify if:

• Any of the following:
• Pregnant women
• Nursing women
• Women of childbearing potential who are unwilling to employ highly effective contraception during dosing with BKM120 and for 4 weeks after the final dose of treatment; NOTE: women of childbearing potential are defined as all women physiologically capable of becoming pregnant
• Men of childbearing potential who are unwilling to employ highly effective contraception during dosing with BKM120 and for 16 weeks after the final dose of treatment and should not a father a child during this time; NOTE: men of childbearing potential are defined as all males physiologically capable of conceiving offspring
• NOTE: the highly effective contraception is defined as either:
• True abstinence: when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
• Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
• Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomized male partner should be the sole partner for that patient
• Use of a combination of any two of the following (a+b):
• Placement of an intrauterine device (IUD) or intrauterine system (IUS)
• Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
• Oral contraception, injected or implanted hormonal methods are not allowed
• Uncontrolled infection
• Average baseline of \>= 4 stools per day

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, Mantle-Cell

Interventions

NVP-BKM120

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Thomas Witzig

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 1, 2012
• Study Start: December 1, 2012
• Primary Completion: September 16, 2016
• Study Completion: March 22, 2017
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

US (1)