View Clinical Trial (Medical Research Study)
Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermed.Grade B-Cell/T-Cell Lymphoma
| City: |
|
New Haven |
| State: |
|
Connecticut |
| Zip Code: |
|
06520 |
| Conditions: |
|
B-Cell Lymphoma |
| Purpose: |
|
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.
|
| Study Summary: |
|
|
| Criteria: |
|
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
- Absolute neutrophil count (ANC) ≥ 1000 x 10 9/L
- White blood cell (WBC) count > 2.5 x 10 9/L
- Platelets ≥ 75 x 10 9/L
- Hemoglobin (Hg) > 9.0 g/dL
- Total bilirubin ≤2.0 mg/dL
- Aspartate transaminase (AST)/alanine transaminase (ALT) ≤3 × upper limit of
normal (ULN)
- Serum creatinine ≤2.0 mg/dL
- 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:
- Previously untreated B-cell lymphoma.
- Received previous treatment with clofarabine.
- Patients with known AIDS-related or HIV-positive lymphoma.
- Autologous bone marrow or stem cell transplant within 6 months of study entry.
- Prior radiotherapy to the only site of measurable disease.
- Any medical condition that requires chronic use of oral high-dose corticosteroids
greater than 20 mg/day prednisone.
- Active autoimmune thrombocytopenia.
- Use of investigational agents within 30 days or any anticancer therapy within 3 weeks
before study entry. The patient must have recovered from all acute toxicities from
any previous therapy.
- Patients with an active, uncontrolled systemic infection considered to be
opportunistic, life threatening, or clinically significant at the time of treatment
or with a known or suspected fungal infection (ie, patients on parenteral antifungal
therapy).
- Active secondary malignancy.
- Pregnant or lactating patients.
- Any significant concurrent disease, illness, or psychiatric disorder that would
compromise patient safety or compliance, interfere with consent, study participation,
follow up, or interpretation of study results.
- Patients with active or untreated central nervous system (CNS) lymphoma.
|
| NCT ID: |
|
NCT00338494 |
| Primary Contact: |
|
Principal Investigator
Francine Foss, M.D.
Yale University
Noelle Sowers, R.N.
Phone: 203-785-2442
Email: noelle.sowers@yale.edu
|
| Backup Contact: |
|
Email: donna.lacivita@yale.edu
Donna LaCivita
Phone: 203-737-2579
|
| Location Contact: |
|
New Haven, Connecticut 06520
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 18, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|