Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Clofarabine is a new chemotherapy drug which was FDA approved for the treatment of acute lymphocytic leukemia in children. This study is being done to see if Clofarabine works in adult patients with B-cell types of lymphoma.
This research is being done to develop new treatments for patients with lymphoma whose cancer has returned or resisted treatment with previous chemotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clofarabine | Drug | The starting dose of clofarabine will be 10 mg/m2 once a week for 3 weeks repeated every 4 weeks with dose escalations to 15, 20 , 30 and 40 mg/m2/week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| tolerated dose (MTD) of clofarabine | at the completion of dose escalation | |
| characterize and quantify the toxicity profile associated with clofarabine | upon completion of the study | |
| determine the overall response rate, plus partial response of clofarabine | upon completion of the study |
Not provided
Not provided
Inclusion Criteria:
Adult patients who are at least 18 years old
Histologically confirmed low grade or intermediate-grade B-cell lymphoma
Relapsed or refractory to at least one standard chemotherapy regimen. Patients who have received Rituximab alone without having received a cytotoxic agent are not eligible.
Measurable disease, defined by the Cheson lymphoma criteria.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Life expectancy greater than 12 weeks
Laboratory values obtained ≤2 weeks prior to entry
Normal cardiac function, defined as an ejection fraction ≥45% determined by pretreatment radionuclide ventriculography (RVG) or echocardiogram.
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francine Foss, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Comprehensive Cancer Center at Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
Not provided
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077866 | Clofarabine |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |