Clinical trial NCT00644189: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Keywords: clofarabine
Clolar
lymphoma
NHL
oral chemotherapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Brigham and Women's Hospital
name: Genzyme, a Sanofi Company
First posted: 2008-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: All Phase I-II Participants: Overall Response Rate (ORR)
timeFrame: after at most 6 28-day cycles
measure: Phase I Participants Only: Overall Response Rate (ORR)
timeFrame: after at most 6 28-day cycles
Secondary outcomes:
measure: Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)
timeFrame: after at most 6 28-day cycles
measure: All Phase I-II Participants: Progression-free Survival (PFS)
timeFrame: at 1 and 2 years
measure: All Phase I-II Participants: Overall Survival (OS)
timeFrame: 3 years
measure: All Phase I-II Participants: Safety
timeFrame: during 6 28-day cycles and 90 days out
measure: Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)
timeFrame: after at most 6 28-day cycles
measure: Phase I Participants: Progression-free Survival (PFS)
timeFrame: at 17 months
measure: All Phase I Participants: Overall Survival (OS)
timeFrame: at 17 months
measure: Phase I Participants: Safety
timeFrame: during 6 28-day cycles and 90 days out
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeremy Abramson, MD
role: PRINCIPAL_INVESTIGATOR
References: