A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
- Pathologic confirmation of relapsed or refractory lymphoma.
1. DLBCL stage II-IV
2. Follicular lymphoma
- At least one site of measurable disease (≥ 2.0 cm with conventional techniques;
physical exam [PE], CT, X-ray, MRI).
- Prior treatment:
1. DLBCL cohort: Disease progression following initial therapy and transplant
(unless the patient is ineligible or refused transplant). There is no limit to
number of prior therapies.
2. Follicular lymphoma cohort: Follicular lymphoma that is relapsed following or
refractory to standard therapy and/or existing therapies or are not eligible for
or are unlikely to achieve clinical benefit from those therapies. Patients must
have failed 3 or more prior therapies.
- Must have at least one of the following considered related to disease:
1. Local symptoms due to progressive or bulky nodal disease.
2. Compromise of normal organ function due to progressive or bulky disease.
3. Presence of systemic B symptoms.
4. Presence of symptomatic extranodal disease.
5. Cytopenias due to extensive bone marrow infiltration, autoimmune hemolytic
anemia or thrombocytopenia, or hypersplenism.
- ECOG performance status of 0 or 1.
- Aged 18 years or older.
- Laboratory requirements.
- Patients with another active cancer (excluding basal cell carcinoma or cervical
intraepithelial neoplasia [CIN/cervical in situ] or melanoma in situ). Prior history
of cancer is allowed, as long as there is no active disease.
- Pregnant or lactating women.
- Patients with uncontrolled intercurrent illness, active or uncontrolled infections,
or a fever >38.5 Celsius (not due to tumor fever) on the day of scheduled dosing.
- Patients with a history of pericardial disease.
- Patients with small, moderate or large pericardial effusions or patients with a
diagnosis of pericarditis.
- Patients with significant cardiac abnormalities.
- Patients with serious illnesses, medical conditions, or other medical history which
would be likely to interfere with patient's participation in the study or with the
interpretation of the results.
- Patients who have been treated with any investigational drug within 28 days prior to
- Known hypersensitivity to HDAC inhibitors and to any components of MGCD0103.
- Known human immunodeficiency virus (HIV) or active Hepatitis B or C.
- Central nervous system lymphoma and lymphoma involving leptomeningeal area.