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A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
study initiation.

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

1 year (anticipated)

Safety Issue:


Principal Investigator

Gregory Reid, MSc, MBA

Investigator Role:

Study Director

Investigator Affiliation:

MethylGene Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

January 2012

Related Keywords:

  • Lymphoma
  • Relapsed and Refractory Lymphoma
  • Phase II
  • Lymphoma



MD Anderson Cancer Center Houston, Texas  77030-4096
Duke University Adult Bone Marrow Transplant Clinic Durham, North Carolina  27710