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Lymphoma, Non-HodgkinPhase 2NCT00061672

Study Evaluating the Safety and Effectiveness of ABT-510 in Subjects With Refractory Lymphoma

A Phase 2 study testing ABT-510 - Thrombospondin-1 Mimetic in people with Lymphoma, Non-Hodgkin and Hodgkin's Lymphoma, run by Abbott at 14 sites 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

The primary objective of this study is to assess the safety and effectiveness of ABT-510 in subjects with refractory lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin, Hodgkin's Lymphoma
What is being tested?
ABT-510 - Thrombospondin-1 Mimetic
How many people
67 participants
Where
14 sitesUnited States
Study dates
Apr 2003to not given
Phase
Phase 2
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

  • A subject will be eligible for study participation if all of the following criteria are met:
  • The subject is at least 18 years of age.
  • The subject has histologically confirmed non-Hodgkin's Lymphoma (NHL) (excluding Burkitt's, Burkitt's type or HIV associated lymphoma) or Hodgkin's Lymphoma (HL) that is refractory to or has relapsed after standard therapy or for which there is no known effective treatment.
  • The subject must have measurable disease by the CHESON Criteria for Tumor Response.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
  • The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
Show all 12Show fewer
  • The subject must have adequate bone marrow, renal and hepatic function as follows:
  • Bone marrow: *White blood cell count (WBC) greater than or equal to 3,000/mm3; *Platelets greater than or equal to 75,000/mm3 unless subject has received a prior transplant or bone marrow involvement with lymphoma has been documented, then platelets of equal to or greater than 50,000 is acceptable. *Hemoglobin greater than or equal to 8.5 g/dL; *ANC greater than or equal to 1000/mm3
  • Renal function: *Serum creatinine less than or equal to 2.0 mg/dL
  • Hepatic function: *AST and ALT less than or equal to 3.0 X ULN
  • The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed appropriate by the investigator while in the study and up to two months following completion of therapy.
  • The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.

Who cannot join

  • A subject will be ineligible for study participation if any of the following criteria are met:
  • The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases.
  • The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g., low dose Coumadin) for catheter prophylaxis is permitted; PT/PTT must be within normal limits.
  • The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks of Study Day 1) or currently exhibits other clinically significant events of bleeding.
  • The subject has received any therapy for lymphoma including chemotherapy, antibody therapy, radiotherapy or any investigational therapy within four weeks prior to study drug administration.
  • The subject has been initiated on steroids or there is an increase in current steroid dose within three months prior to study drug administration.
  • The subject exhibits evidence of clinically significant uncontrolled condition(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
  • The subject has history of other previous malignancies within 5 years, with the exception of: Adequately treated in situ carcinoma of the cervix; Basal or squamous cell carcinoma of the skin.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Albany Regional Cancer Center

    Albany, New York, 12208

  • The Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • Raleigh Hematology Oncology Clinic

    Cary, North Carolina, 27511

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Kansas City Oncology and Hematology Group

    Kansas City, Missouri, 64111

  • USC - Norris Cancer Center

    Los Angeles, California, 90033

  • U of W - Comprehensive Care Center

    Madison, Wisconsin, 53792

  • The West Cancer Clinic

    Memphis, Tennessee, 38120

  • Oncology-Hematology Group of South Florida

    Miami, Florida, 33176

  • Cancer Centers of Florida, P.A.

    Orlando, Florida, 32806

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Hematology Oncology Associates

    San Antonio, Texas, 78229

  • Arch Medical Services, INC.

    St Louis, Missouri, 63142

  • Arizona Clinical Research Center

    Tucson, Arizona, 85712

Other trials in United States

About this study

Official title: A Phase II Study Evaluating the Safety and Effectiveness of ABT-510 in Subjects With Refractory Lymphoma

The primary objective of this study is to assess the safety and effectiveness of ABT-510 in subjects with refractory lymphoma.

Being tested
ABT-510 - Thrombospondin-1 Mimetic
Keywords
Non-Hodgkin's Lymphoma (NHL), Hodgkin's Lymphoma (HL)
Medical subject headings
Lymphoma, Non-Hodgkin, Hodgkin Disease

What participants receive

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

  • ABT-510 - Thrombospondin-1 MimeticDrug

What is being measured

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

  1. Response rate

    Measured: One year

Secondary outcomes (3)

  1. Progression free survival

    Measured: One year

  2. Overall survival

    Measured: One year

  3. Performance status

    Measured: One year

Timeline

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

  1. First posted4 Jun 2003 (estimated)
  2. Study startApr 2003

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00061672
Sponsor's protocol ID
M02-457
Status last verified
Aug 2007
First submitted
2 Jun 2003
Last updated
15 Aug 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-510 - Thrombospondin-1 Mimetic in people with Lymphoma, Non-Hodgkin and Hodgkin's Lymphoma, run by Abbott at 14 sites 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 12 inclusion and 8 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 15 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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 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?

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?

Response rate (time frame: One year). 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 NCT00061672.

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 15 Aug 2007.

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