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LeukemiaPhase 1NCT00457860

Safety Study of CAT-8015 Immunotoxin in Patients With CLL, PLL or SLL With Advance Disease

A Phase 1 study testing Immunotoxin therapy, CAT-8015 immunotoxin and Biological therapy in people with Leukemia, run by Cambridge Antibody Technology at 4 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), or small lymphocytic lymphoma (SLL that has not responded to chemotherapy, surgery or radiation therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
Immunotoxin therapy, CAT-8015 immunotoxin and Biological therapy
Type of treatment
Surgery or procedure
How many people
50 participants
Where
4 sitesin 2 countries
Study dates
Mar 2007to not given
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

  • DISEASE CHARACTERISTICS:
  • Confirmed diagnosis of B-cell leukemia (CLL, PLL or SLL)
  • Measurable disease
  • Patients with chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL) are eligible if they have failed 2 or more prior courses of standard chemotherapy and/or biologic therapy (e.g. Rituxan) and if treatment for progressive disease is medically indicated. Patients with prolymphocytic leukemia (PLL) will be eligible if they have failed at least one prior standard chemotherapeutic regimen. Medical indications for treatment include progressive disease-related symptoms, progressive cytopenias due to marrow involvement, progressive or painful splenomegaly or adenopathy, rapidly increasing lymphocytosis, autoimmune hemolytic anemia or thrombocytopenia and increased frequency of infections.
  • PATIENT CHARACTERISTICS:
  • Performance status
Show all 13Show fewer
  • ECOG 0-2
  • Life expectancy
  • Life expectancy of greater than 6 months, as assessed by the principal investigator
  • Other
  • Patients with other cancers who meet eligibility criteria and have had less than 5 years of disease-free survival will be considered on a case-by-case basis
  • Ability to understand and sign informed consent
  • Female and male patients agree to use an approved method of contraception during the study

Who cannot join

  • Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion)
  • History of bone marrow transplant
  • Pregnant or breast-feeding females
  • Patients whose plasma contains either a significant level of antibody to CAT-8015 as measured by ELISA, or antibody that neutralizes the binding of CAT-8015 to CD22 as measured by a competition ELISA.
  • HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs)
  • Hepatitis B surface antigen positive
Show all 20Show fewer
  • Uncontrolled, symptomatic, intercurrent illness including but not limited to: infections requiring systemic antibiotics, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements
  • Hepatic function: serum transaminases (either ALT or AST) or direct bilirubin:
  • ≥ Grade 2, unless bilirun is due to Gilbert's disease
  • Renal function: serum creatinine clearance ≤60mL/min as estimated by Cockroft-Gault formula
  • Hematologic function:
  • The ANC <1000/cmm, or platelet count <50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy)
  • Baseline coagulopathy > grade 3 unless due to anticoagulant therapy
  • A patient will not be excluded because of pancytopenia ≥ Grade 3, or erythropoietin dependence, if it is due to disease, based on the results of bone marrow studies
  • Pulmonary function:
  • Patients with < 50% of predicted forced expiratory volume (FEV1) or <50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Note: Patients with no prior history of pulmonary illness are not required to have PFTs. FEV1 will be assessed following bronchodilator therapy.
  • Recent prior therapy:
  • Cytotoxic chemotherapy, corticosteriods (except stable doses of prednisone), whole body electron beam radiation therapy, hormonal, biologic or other systemic therapy or investigational therapy of the malignancy for 3 weeks prior to entry into the trial
  • Less than or equal to < 3 months prior monoclonal antibody therapy (i.e. rituximab)
  • Patients who have received or are receiving radiation therapy less than 3 weeks prior to study entry will be not be excluded providing the volume of bone marrow treated is less than 10% and also the patient has measurable disease outside the radiation port

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites, 3 recruiting

  • Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892

    NCI Clinical Trials Referral Office, 888-624-1937

    Robert J Kreitman, MD

    Recruiting

  • Tower Hematology Oncology Medical Group

    Beverly Hills, California, 90211

    Marie Fuerst, RN, MS, 310-285-7269

    Peter Rosen, MD

    Recruiting

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

    Mary Cangany, RN, CCRP, 317-278-4694

    Larry Cripe, MD

    Not yet recruiting

Other trials in United States

Poland1 site, 1 recruiting

  • Klinika Hemtologii Uniwersytetu Medycznego (Medical University of Lodz)

    Lodz

    Krzysztof Jamoziak, MD, 00 48 42 689 5191

    Tadeusz Robak, Professor

    Not yet recruiting

Other trials in Poland

About this study

Official title: A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia (CLL), Prolymphocytic Leukemia (PLL), or Small Lymphocytic Lymphoma (SLL)

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), or small lymphocytic lymphoma (SLL that has not responded to chemotherapy, surgery or radiation therapy.

PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have chronic lymphocytic leukemia, prolymphocytic leukemia or small lymphocytic lymphoma that has not responded to treatment

Read the detailed description

OUTLINE: Patients receive CAT-8015 IV over 30 minutes on days 1, 3, and 5 followed by rest. Treatment repeats every 4 weeks for up to a total of 10 courses in the absence of dose limiting toxicity, complete response or disease progression. Patients are followed at 1, 3, 6,12,15,18, 21, 24 months following the start of the last treatment cycle.

Cohorts of 3-6 patients each will receive escalating doses of recombinant CAT-8015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, between16 to 25 new patients will be added to the MTD cohort depending on how well the CAT-8015 is tolerated.

Conditions
Leukemia
Being tested
Immunotoxin therapy, CAT-8015 immunotoxin, Biological therapy
Keywords
CLL, PLL, SLL, Relapse, Refractory, immunotoxin, HA22, CAT-8015, immunotherapy
Medical subject headings
Leukemia, Recurrence

What participants receive

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

  • Immunotoxin therapyDrug

  • CAT-8015 immunotoxinDrug

  • Biological therapyProcedure or surgery

What is being measured

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

  1. Estimate the maximum dose that can be safely administered to a patient

  2. Characterize the toxicity profile of CAT-8015

  3. Study the clinical pharmacology of CAT-8015

  4. Observe anti-tumor activity, if any

Secondary outcomes (2)

  1. To assess the potential of CAT-8015 to induce antibodies

  2. To Investigate the potential of biomarkers to predict any therapeutic or toxic response

Timeline

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

  1. First posted9 Apr 2007 (estimated)
  2. Study startMar 2007

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00457860
Sponsor's protocol ID
CAT-8015-1002
Status last verified
Apr 2007
First submitted
5 Apr 2007
Last updated
17 Apr 2007
Results posted
No
Data monitoring committee
No

Publications

  • Kreitman RJ, Squires DR, Stetler-Stevenson M, Noel P, FitzGerald DJ, Wilson WH, Pastan I. Phase I trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with B-cell malignancies. J Clin Oncol. 2005 Sep 20;23(27):6719-29. doi: 10.1200/JCO.2005.11.437. Epub 2005 Aug 1.

    PubMed 16061911

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Immunotoxin therapy, CAT-8015 immunotoxin and Biological therapy in people with Leukemia, run by Cambridge Antibody Technology at 4 sites in 2 countries.

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 13 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 17 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Poland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate the maximum dose that can be safely administered to a patient. The study lists 4 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 NCT00457860, 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 17 Apr 2007.

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