Epigenetic Modulation in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Stopped early · Phase 2

Conditions studied: Diffuse Large B-cell Lymphoma

In brief

The purpose of this study is evaluate the response, safety and tolerability in subjects receiving the investigational drugs, RAD001 and LBH589. Subjects in Part 1 will receive one drug for four cycles followed by 4 cycles of the second drug unless they achieve complete remission. Subjects in a complete remission may receive up to 6 cycles of study drug and will not receive the next study drug until there is evidence of disease progression. Subjects in Part 2 will receive both drugs together for at least 2 cycles and up to 13 if tolerated.

Key facts

Study ID

NCT00978432

Run by

Anne Beaven, MD

People needed

50

Starts

2012-02-01

Expected to finish

2016-03-01

Last updated by the study team

2016-11-25

Who can join

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

You may qualify if…

• de novo or transformed Diffuse large B cell non-Hodgkin lymphoma (DLBCL). DLBCL-like lymphomas allowed:
• Epstei-Barr virus (EBV)+ DLBCL in elderly,
• DLBCL with chronic inflammation,
• Primary cutaneous DLBCL, leg type,
• B cell lymphoma unclassifiable - between DLBCL and Burkitt lymphoma,
• B cell lymphoma unclassifiable - between large B cell lymphoma and classical Hodgkin lymphoma,
• Anaplastic lymphoma kinase (ALK)+ large B cell lymphoma,
• T cell histiocyte rich large B cell lymphoma
• Primary mediastinal B cell lymphoma
• Follicular grade 3 B cell lymphoma
• Refractory or relapsed disease to >/= 1 prior treatment regimen: should include autologous stem cell transplant unless patient refused or ineligible.
• Age > 18 years old
• Eastern Cooperative Oncology Group (ECOG) performance status <2.
• Measurable or evaluable disease by physical exam, radiographs or bone marrow involvement
• Frozen tumor or paraffin-embedded sample available.
• 3-4 core fresh/fresh-frozen biopsy specimens available. Leukapheresis may be done for patients with leukocytosis.
• Laboratory Values per protocol.

You may not qualify if…

• Laboratory Values
• Grade 3 hyperlipidemia (Serum cholesterol >400mg/dl or serum triglycerides >5 x ULN)
• Serum Glucose > 250mg/dl on >/= 2 checks on 2 separate days
• Diabetics accepted if sugars controlled
• Unlimited prior chemotherapy regimens, however:
• No prior exposure to RAD001 or LBH589 or drugs that target mTOR (sirolimus, temsirolimus, etc) or HDAC (vorinostat)
• No valproic acid during study or 5 days preceding start of first drug
• No chemotherapy, biologics or immunotherapy < 2 weeks before registration (6 weeks if last received bis-chloroethylnitrosourea (BCNU) or mitomycin C). Subjects must be recovered from therapy-related non-hematological toxicities to < grade 1 or baseline if started with > grade 1 toxicity.
• No time limit for radiation prior to registration.
• No radioimmunotherapy < 2 months prior to registration. Subjects must be recovered from therapy-related toxicities to < grade 1 or baseline if started with > grade 1 toxicity.
• No prior allogeneic stem cell transplantation unless allogeneic engraftment is <2%.
• Subjects receiving chronic, systemic treatment with corticosteroids = to >20mg of prednisone per day.
• Subjects receiving replacement for adrenal insufficiency allowed.
• Topical or inhaled corticosteroids allowed.
• History of other primary malignancy < 3 years ago, except inactive basal, squamous cell carcinoma of the skin or superficial melanoma only requiring excision, prostate cancer with a prostate specific antigen (PSA) stable for >/=3 months, carcinoma in situ of cervix.
• Major surgery < 4 weeks before or Minor surgery < 2 weeks before registration. Subjects must be recovered from toxicities to < grade 1 or baseline if started with > grade 1 toxicity.
• Investigational drugs < 4 weeks prior to registration.
• Impaired Cardiac Function per protocol.
• Pregnant or breastfeeding females or adults of reproductive potential not using effective birth control
• Diffusing capacity or transfer factor of the lung for carbon monoxide (DLCO) < 40% if tested (per protocol).
• Impaired lung function: O2 saturation 88% or less at rest on room air by Pulse Oximetry.
• Immunization with live attenuated vaccines < 1 week of study entry
• Impaired GI function or GI disease that may alter absorption of RAD001 or LBH589
• Concurrent severe \&/or uncontrolled medical conditions
• Medications with risk of prolonging QT interval or inducing torsade de pointes or interacting with LBH589 and RAD001 may be used per the protocol.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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