B-Cell LymphomaPhase 1NCT00338494
Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma
A Phase 1 study testing Clofarabine in people with B-Cell Lymphoma, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Lymphoma
- What is being tested?
- Clofarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermed.Grade B-Cell/T-Cell Lymphoma
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.
- Conditions
- B-Cell Lymphoma
- Being tested
- Clofarabine
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClofarabineDrug
Also called CAFdA, Cl-F-ara-A
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
tolerated dose (MTD) of clofarabine
Measured: at the completion of dose escalation
characterize and quantify the toxicity profile associated with clofarabine
Measured: upon completion of the study
determine the overall response rate, plus partial response of clofarabine
Measured: upon completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startOct 2005
- Primary completionMar 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Francine Foss, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338494
- Sponsor's protocol ID
- 0506000158
- Status last verified
- Jan 2015
- First submitted
- 15 Jun 2006
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermed.Grade B-Cell/T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00338494
- Acronym / sponsor ID
- 0506000158
- Conditions
- B-Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Oct 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Clofarabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClofarabineAlso: CAFdA, Cl-F-ara-AThe 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. | Drug | 1 |
Primary outcome
tolerated dose (MTD) of clofarabine
Time frame: at the completion of dose escalation
characterize and quantify the toxicity profile associated with clofarabine
Time frame: upon completion of the study
determine the overall response rate, plus partial response of clofarabine
Time frame: upon completion of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francine Foss, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clofarabine in people with B-Cell Lymphoma, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tolerated dose (MTD) of clofarabine (time frame: at the completion of dose escalation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2015.