Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma

Brief Title

Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma

Official Title

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

Brief Summary

      Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and
      works in two different ways. It affects the development of new cancer cells by blocking two
      enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call
      can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing
      cancer cells to die by disturbing components within the cancer cell. This causes the release
      of a substance that is fatal to the cell.

      This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin
      lymphomas.

Detailed Description

      -  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
           worse.

        -  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.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

All Phase I-II Participants: Overall Response Rate (ORR)

Secondary Outcome

 Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)

Condition

Follicular Lymphoma

Intervention

Clofarabine

Study Arms / Comparison Groups

 Clofarabine

Description:  Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

June 2008

Completion Date

July 2022

Primary Completion Date

December 2013

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jeremy Abramson, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00644189

Organization ID

07-401

Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Collaborators

 Dana-Farber Cancer Institute

Study Sponsor

Jeremy Abramson, MD, Principal Investigator, Massachusetts General Hospital

Verification Date

January 2021