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Lymphoma, B-CellPhase 1/2NCT00156013

Clofarabine for Relapsed or Refractory T-Cell or B-Cell Non-Hodgkin Lymphoma (NHL)

A Phase 1/2 study testing CLOFARABINE in people with Lymphoma, B-Cell and Lymphoma, Non-Hodgkin, run by Oncology Specialists, S.C. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research is being done to develop new treatment for non-hodgkin's lymphoma in subjects whose cancer has returned or resisted treatment with chemotherapy. The investigational drug clofarabine is being used in this study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, B-Cell, Lymphoma, Non-Hodgkin
What is being tested?
CLOFARABINE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
Sep 2005to Apr 2010
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 with histology confirmed diffuse large cell B-cell NHL who have failed prior systemic chemotherapy with or without monoclonal antibody-based therapies.
  • Measurable disease determined by Ct or PET scans or bone marrow involvement, defined as lesions that can be accurately measured in two dimensions by CT or PET scan with the longest diameter accurately as greater than or equal to 1.0 cm or palpable lesions with both diameters greater than or equal to 2.0 cm. PET scan measurable disease is defined based on SUV value as determined by nuclear medicine evaluation.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0,1,or 2.
  • Life expectancy greater than 12 weeks.
  • Laboratory values obtained less than or equal to 14 days prior to registration:
  • Absolute neutrophil count (ANC) greater than or equal to 1500.
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  • White blood cell (WBC) count greater than 3.0.
  • Platelets greater than or equal to 100.
  • Hemoglobin (HG) greater than 9.0 g/dL.
  • Total bilirubin less than or equal to 2.0 mg/dL.
  • Aspartate transaminase (AST)/alanine transaminase (ALT) less than or equal to 3 times the upper limit of normal (ULN). Higher values are acceptable if it is deemed that they are related to liver involvement with NHL.
  • Serum creatinine less than or equal to 2.0 mg/dL.
  • Cardiac function on pretreatment MUGA scan or echocardiogram that is considered normal by institutional standards.
  • 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 minium of 6 months after study treatment.

Who cannot join

  • Previously untreated NHL.
  • Received previous treatment with clofarabine.
  • History of T-cell lymphoma.
  • Bulky disease (ie, any single mass greater than 10 cm or circulating malignant cells greater than or equal to 24,000 cells/ul.
  • Patients with known AIDS-related or HIV-positive lymphoma.
  • Autologous bone marrow or stem cell transplant within 3 months of study entry.
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  • History of allogeneic bone marrow transplant or organ transplant.
  • Prior radiotherapy to the only site of measurable disease.
  • Any medical condition that requires chronic use of oral high-dose corticosteroids. ( in excess of 1 mg/kg/day).
  • Autoimmune thrombocytopenia.
  • Use if 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 of parenteral antifungal therapy).
  • HIV-positive status.
  • 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 lymphoma (CNS) lymphoma.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oncology Specialists, SC

    Park Ridge, Illinois, 60068

Other trials in United States

About this study

Official title: A Phase I/II Open-label Study of Clofarabine in Patients With Relapsed or Refractory Diffuse Large Cell B-Cell NHL

This research is being done to develop new treatment for non-hodgkin's lymphoma in subjects whose cancer has returned or resisted treatment with chemotherapy. The investigational drug clofarabine is being used in this study. An investigational drug is one that has not been approved by the United States Food and Drug Administration (FDA).

Read the detailed description

The safety profile of clofarabine appears acceptable within the target populations studied to date in the clinical studies, with numerous responses observed in heavily pre-treated patients with relapsed/refractory ALL or AML. Dose escalation of clofarabine in patients with solid tumors and lymphoproliferative disorders has been limited because grade 3 and 4 myelosuppression was considered acceptable in patients with acute leukemia, provided that hematologic recovery occurred within 6 weeks of therapy , and dose escalation has proceeded as high as 40 mg/m2 in this patient population. Furthermore, no responses were observed in a recent trial in which patients with relapsed CLL were treated with clofarabine 2 mg/m2, an indolent B-cell lymphoproliferative disorder indicating that low doses are likely to be ineffective in patients with aggressive NHL. (Personal Communication with ILEX Products, INC.)

This Phase I/II study will evaluate escalating doses of clofarabine in patients with relapsed and refractory diffuse large cell B-cell NHL starting at a dose of 4 mg/m2/day for 5 consecutive days and repeated every 28 days for a maximum of 6 cycles. This dosing regimen should be evaluated in this patient population because there is no standard therapy at relapse and grade 3 and 4 myelosuppression is frequently observed with traditional NHL salvage. Additionally, patients will receive granulocyte colony stimulating factors at the discretion of the investigator. Antifungal and antibacterial prophylaxis will be administered to minimize the risk of infection.

Being tested
CLOFARABINE
Keywords
B-Cell NHL
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLOFARABINEDrug

    Also called Clolar®

    4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles

Study groups in NCT00156013
Study groupRoleWhat they receive
1ExperimentalClofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
Receives: Drug: CLOFARABINE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I Maximum Tolerated Dose

    Maximum Tolerated Dose for Clofarabine. Cohorts of 3 patients each will receive doses of clofarabine increased in increments as follows: 4, 6, 8, 10, 12,…etc mg/m2/day for 5 days. The dose level immediately below the MTD will be used to treat patients in the Phase II part of the study. Starting dose of 4 mg/m2.

    Measured: days 1 -28, maximum 6 cycles

  2. Phase II Overall Response

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 5 years

Secondary outcomes (1)

  1. Toxicity

    Number of Participants with Toxicity

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00156013
Sponsor's protocol ID
1066306 (0408)
Status last verified
Oct 2017
First submitted
8 Sep 2005
Last updated
29 Nov 2017
Data monitoring committee
No

Publications

  • Nabhan C, Davis N, Bitran JD, Galvez A, Fried W, Tolzien K, Foss S, Dewey WM, Venugopal P. Efficacy and safety of clofarabine in relapsed and/or refractory non-Hodgkin lymphoma, including rituximab-refractory patients. Cancer. 2011 Apr 1;117(7):1490-7. doi: 10.1002/cncr.25603. Epub 2010 Nov 8.

    PubMed 21425150

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CLOFARABINE in people with Lymphoma, B-Cell and Lymphoma, Non-Hodgkin, run by Oncology Specialists, S.C. 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 16 inclusion and 17 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 Nov 2017. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase I Maximum Tolerated Dose (time frame: days 1 -28, maximum 6 cycles). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00156013, which also lists 1 linked publication.

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 Nov 2017.

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