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

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ClinicalTrials.gov Identifier: NCT00156013
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : July 9, 2012
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.

Study Description
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Brief 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. An investigational drug is one that has not been approved by the United States Food and Drug Administration (FDA).

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Lymphoma, Non-Hodgkin Drug: CLOFARABINE Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Open-label Study of Clofarabine in Patients With Relapsed or Refractory Diffuse Large Cell B-Cell NHL
Study Start Date : September 2005
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Clofarabine

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
 Drug: CLOFARABINE
4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles
Other Name: Clolar®


Outcome Measures
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Primary Outcome Measures :
  1. Phase I Maximum Tolerated Dose [ Time Frame: days 1 -28, maximum 6 cycles ]
    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.

  2. Phase II Overall Response [ Time Frame: 5 years ]
    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.


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 5 years ]
    Number of Participants with Toxicity


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
    • 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.

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156013


Locations
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United States, Illinois
Oncology Specialists, SC
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Oncology Specialists, S.C.
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: Chadi Nabhan, MD Oncology Specialists,SC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Sigrun Hallmeyer, Principal Investigator, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00156013    
Obsolete Identifiers: NCT00305721
Other Study ID Numbers: 1066306 (0408)
First Posted: September 12, 2005    Key Record Dates
Results First Posted: July 9, 2012
Last Update Posted: November 29, 2017
Last Verified: October 2017
Keywords provided by Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.:
B-Cell NHL
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Clofarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents