Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Genzyme

Information provided by (Responsible Party):

Jeremy Abramson, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00644189

First received: March 24, 2008

Last updated: March 11, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 24, 2008

Last Updated Date

March 11, 2013

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Phase II: Determine the efficacy of oral clofarabine in patients with relapsed/refractory non-Hodgkin lymphoma using overall response rate (complete and partial). [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00644189 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Phase I: To determine the MTD and efficacy of oral clofarabine in patients with relapsed/refractory non-Hodgkin lymphoma. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Phase II: Determine the duration of response, progression-free survival and overall survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Phase I: To determine the efficacy of oral clofarabine in patients with relapsed/refractory non-Hodgkin lymphoma. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Phase II: Determine the duration of response, progression-free survival and overall survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma

Official Title ^ICMJE

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.

The phase I component of this research study is complete and demonstrated encouraging safety and efficacy in low-grade B-cell lymphomas. The phase II component of the trial is accruing to further study 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 Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Clofarabine

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

Other Name: Clolar

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00644189

Other Study ID Numbers ^ICMJE

07-401

Has Data Monitoring Committee

Yes

Responsible Party

Jeremy Abramson, MD, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Dana-Farber Cancer Institute
Brigham and Women's Hospital
Genzyme

Investigators ^ICMJE

Principal Investigator:

Jeremy Abramson, MD

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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