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Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma

Phase 2
18 Years
65 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma

Thank you

Trial Information

Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma

Inclusion Criteria:

- Histologic diagnosis of diffuse large B cell lymphoma, PMLBL, or follicular lymphoma
grade 3B confirmed by the department of hematopathology at MSKCC: Patients with
discordant bone marrow involvement (i.e. involvement by small cleaved cells or small
lymphocytic lymphoma) are eligible.

- Tumors express CD20 as determined by immunohistochemistry.

o Ki-67 evaluation of tumor tissue

- Patients must have stage III, or IV disease. Patients with IIX, disease must have at
least one other age-adjusted IPI risk factor.

- KPS ≤ 70

- LDH > upper limit of normal

- All patients must have FDG-PET avid (minimum SUV 2.5) measurable disease

- Patients must have normal baseline cardiac function based upon echocardiogram or
gated blood pool scan (MUGA) with an ejection fraction ≥ 50%

- Patients must have a serum creatinine of ≤ 1.5 mg/dl; if creatinine >1.5 mg/dl
creatinine clearance must be >60 ml/minute.

- Patients must have ANC>1000/mcl and Platelets>50,000/mcl. If patient has cytopenias
due to bone marrow involvement, these requirements are not applicable.

- Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of
Gilbert's disease (or pattern consistent with Gilbert's)

- Patients must be Hepatitis B surface antigen negative, Hepatitis B core antibody
negative, and Hepatitis C negative.

- All patients of childbearing and child creating age must be using an acceptable form
of birth control from the initiation of treatment on study until 1 year after
completion of chemotherapy and/or transplant.

- Women who are pre-menopausal must have a negative pregnancy test

- Age between 18 and 65

- Patients must be HIV negative. This test may be pending in a patient without risk
factors, as determined by the patient's physician.

- If patients have a history of malignancy other than cutaneous basal cell or squamous
cell carcinoma, they must be disease-free for ≥ 5 years at the time of enrollment.

- Patients or their guardians must be capable of providing informed consent.

- Patients must be suitable to undergo stem cell transplant.

Exclusion Criteria:

- Any lymphoma subtype other than DLBCL, PMLBL, follicular lymphoma grade 3B

- Patients with either parenchymal brain or lepto-meningeal involvement.

- No more than 14 days of prednisone therapy between the diagnostic biopsy of either
DLBCL, PMLBL, or follicular lymphoma grade 3B and the initiation of treatment on

- Known pregnancy or breast-feeding

- Medical illness unrelated to NHL which in the opinion of the attending physician and
principal investigator will preclude administration of chemotherapy safely. This
includes patients with uncontrolled infection, chronic renal insufficiency,
myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias
other than chronic atrial fibrillation and chronic active or persistent hepatitis, or
New York Heart Association Classification III or IV heart disease.

- History of any malignancy for which the disease-free interval is <5 years, excluding
curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma
in-situ of the cervix.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the 2-year PFS and overall survival from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation.

Outcome Time Frame:

conclusion of the study

Safety Issue:


Principal Investigator

Craig Moskowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

July 2014

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Non-Hodgkin
  • Lymphoma
  • Rituximab
  • Cyclophosphamide
  • Doxorubicin
  • Vincristine
  • ifosfamide
  • etoposide
  • carboplatin
  • stem cell transplant
  • 08-026
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



Memorial Sloan Kettering Cancer Center New York, New York  10021