NCT00156013

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

July 9, 2012

Completed
Last Updated

November 29, 2017

Status Verified

October 1, 2017

Enrollment Period

4.6 years

First QC Date

September 8, 2005

Results QC Date

October 6, 2011

Last Update Submit

October 24, 2017

Conditions

Lymphoma, B-CellLymphoma, Non-Hodgkin

Keywords

B-Cell NHL

Outcome Measures

Primary Outcomes (2)

  • 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.

    days 1 -28, maximum 6 cycles

  • 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.

    5 years

Secondary Outcomes (1)

  • Toxicity

    5 years

Study Arms (1)

1

EXPERIMENTAL

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

Drug: CLOFARABINE

Interventions

CLOFARABINEDRUG

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

Also known as: Clolar®
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Specialists, SC

Park Ridge, Illinois, 60068, United States

Location

Related Publications (1)

  • 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.

    PMID: 21425150DERIVED

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma, Non-Hodgkin

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesNucleotidesRibonucleotides

Results Point of Contact

Title
Chadi Nabhan, MD
Organization
Oncology Specialists
cnabhan@oncmed.net
847-268-8200

Study Officials

  • Chadi Nabhan, MD

    Oncology Specialists,SC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2005

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

November 29, 2017

Results First Posted

July 9, 2012

Record last verified: 2017-10

Locations

US(1)