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

Completed · Early Phase 1

Conditions studied: Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma, Transformed Recurrent Non-Hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT01719250

Run by

Mayo Clinic

People needed

7

Starts

2012-12-01

Expected to finish

2017-03-22

Last updated by the study team

2018-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Serum lipase =< ULN
• Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)
• Serum calcium =< 10.9 mg/dL
• Negative pregnancy test done =< 72 hours prior to starting drug, for women of childbearing potential only
• Provide informed written consent
• Willing to return to Mayo Clinic Rochester for follow-up
• Willing to provide blood samples for correlative research purposes
• Willingness to take BKM120 orally

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
• Therapy with myelosuppressive chemotherapy or biologic therapy < 21 days prior to registration unless the patient has recovered from the nadir of the previous treatment to a level that meets the inclusion eligibility criteria of this protocol
• Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 5 effective half-lives prior to registration or who have not recovered from side effects of such therapy
• Received wide field radiotherapy =< 28 days or limited field radiation for palliation =< 14 days prior to registration or who have not recovered from side effects of such therapy
• Receiving corticosteroids > 10 mg of prednisone per day (or equivalent); NOTE: patients may be receiving stable doses of corticosteroids with a maximum dose of 10 mg of prednisone per day if they are being given for disorders other than lymphoma such as rheumatoid arthritis, polymyalgia rheumatica or adrenal insufficiency, or asthma
• Persistent toxicities >= grade 2 from prior chemotherapy or biological therapy regardless of interval since last treatment
• Active cardiac disease including any of the following:
• Left ventricular ejection fraction (LVEF) < 45% as determined by multi gated acquisition (MUGA) scan or echocardiogram (ECHO)
• Fridericia's corrected QT interval (QTcF) > 450 msec on screening electrocardiogram (ECG) (using the QTcF formula)
• Unstable angina pectoris; patients with unstable angina should have angina controlled before entering the study
• Ventricular arrhythmias except for benign premature ventricular contractions

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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