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A Phase II Study of Oral Clofarabine in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Low Grade B-cell Lymphoma, Not Otherwise Specified, Diffuse Large B-cell Lymphoma, Peripheral T-cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large-cell Lymphoma

Thank you

Trial Information

A Phase II Study of Oral Clofarabine in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma

- Each treatment cycle lasts four weeks during which time the participant will be taking
study drug for the first three weeks only. Participants will be supplied with a study
medication-dosing calendar for each treatment cycle.

- Clofarabine is a tablet that will be taken orally in the morning once daily on days 1
through 21 of each 28-day cycle. Participants can receive up to a total of 6 cycles if
they do not experience any unacceptable side effects and if their cancer does not get

- The following tests and procedures will be performed at specified intervals through out
the treatment period: blood tests, physical examinations, vital signs, radiological
exams and urine tests.

Inclusion Criteria:

- Histologically confirmed relapsed or refractory NHL that includes: follicular
lymphoma of any grade; marginal zone lymphoma; small lymphocytic lymphoma/chronic
lymphocytic leukemia; mantle cell lymphoma; lymphoplasmacytic lymphoma; low-grade
B-cell lymphoma not otherwise specified; diffuse large B-cell lymphoma, anaplastic
large cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma.

- One or more prior line of chemotherapy, immunotherapy, or radioimmunotherapy.

- Measurable disease on cross sectional imaging of at least 2cm.

- ECOG Performance Status 0-2

- 18 years of age or older

- Life expectancy of greater than 3 months

- Normal organ and marrow function as outlined in the protocol

- Must agree to use adequate contraception prior to study entry and for the duration of
study participation

Exclusion Criteria:

- Patients who have had chemotherapy, rituximab, or radiotherapy within 4 weeks, or
radioimmunotherapy within 8 weeks prior to entering the study

- Receiving any other investigational agent

- Known brain metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Clofarabine

- Systemic fungal, bacterial, viral, or other infection not controlled

- Pregnant or lactating

- Prior history of another malignancy (except for non-melanoma skin cancer or in situ
cervical or breast cancer) unless disease free for over one year

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Prior allogeneic stem cell transplantation

Type of Study:


Study Design:

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

Outcome Measure:

Phase II: Determine the efficacy of oral clofarabine in patients with relapsed/refractory non-Hodgkin lymphoma using overall response rate (complete and partial).

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jeremy Abramson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

December 2013

Related Keywords:

  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Mantle Cell Lymphoma
  • Small Lymphocytic Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Low Grade B-cell Lymphoma, Not Otherwise Specified
  • Diffuse Large B-Cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Anaplastic Large-Cell Lymphoma
  • clofarabine
  • Clolar
  • lymphoma
  • NHL
  • oral chemotherapy
  • Immunoblastic Lymphadenopathy
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617