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Chronic Lymphocytic LeukemiaPhase 1NCT00319930

Phase 1, Dose-Escalation, Pharmacodynamic Study of IV CNF1010 in ZAP-70 Positive CLL

A Phase 1 study testing CNF1010 (17-AAG) in people with Chronic Lymphocytic Leukemia, run by Biogen at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to evaluate the effects of increasing doses of CNF1010 on pharmacodynamic markers and hematological response. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
CNF1010 (17-AAG)
How many people
10 participants
Where
6 sitesUnited States
Study dates
May 2005to May 2007
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

  • Diagnosis of B-cell CLL including
  • Lymphocytosis of >=5,000 monoclonal B-cells/microliter co-expressing >= one B-cell marker (CD19, CD20, or CD23) and CD5 in peripheral blood AND
  • <= 55% prolymphocytes AND
  • Bone marrow with >=30% mononuclear cells being lymphocytes
  • ZAP-70 positive CLL
  • Intermediate or High risk, poor prognosis CLL refractory to fludarabine-based therapy as defined by one of the following:
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  • Disease progression following 2 cycles of fludarabine OR
  • Failure to achieve PR or CR after at least 2 cycles OR
  • No response to treatment or stable disease after at least 2 cycles of fludarabine OR
  • Disease progression after chemotherapy treatment after fludarabine-based therapy
  • OR
  • CLL patients intolerant to fludarabine-based therapy. [Intolerance is defined as the development of any serious medical condition occurring after exposure to fludarabine that would restrict further use of the agent as treatment for the patient's CLL (i.e., autoimmune hemolytic anemia, myelosuppression, hypersensitivity)]
  • Indication for treatment as defined by the NCI Working Group Guidelines
  • Laboratory parameters as follows:
  • Hemoglobin >=10 g/dL (may be post-transfusion); platelet count >=50 x103/mm3
  • T. Bili <2 x ULN and ALT and AST <2 x ULN
  • Creatinine <=2 x ULN
  • ECOG Performance Score <=2
  • For patients of child-producing potential, use of effective contraceptive methods during the study and for 1 month following treatment

Who cannot join

  • Pregnant or nursing women
  • Class III or IV cardiac disease defined by the New York Heart Association Functional Classification and/or left ventricular ejection fraction <40%
  • History of prior radiation that potentially included the heart in the field.
  • History of myocardial infarction or active ischemic heart disease within 6 months of study entry
  • History of arrhythmia (including atrial fibrillation, multifocal premature ventricular contractions, ventricular bigeminy or trigeminy, ventricular tachycardia or a requirement for antiarrhythmics (including digoxin)
  • Baseline QTc >=450 msec for men and >= 470 msec for women in the absence of correctable electrolyte imbalance
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  • Poorly controlled angina
  • Congenital long QT syndrome or first-degree relative with unexplained sudden death <40 years of age
  • Presence of left bundle branch block
  • Treatment with chemotherapy, monoclonal antibody or radiotherapy within 28 days of study entry
  • Severe or debilitating pulmonary disease
  • Participation in any investigational drug study within 28 days prior to CNF1010 administration. (Patient must have recovered from all acute effects of previously administered investigational agents)
  • Presence of active malignancy with the exception of basal cell carcinoma
  • Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis
  • Known allergy to soy
  • Requirement for concomitant therapy with drugs that alter metabolism by cytochrome P450 3A4 except low-dose warfarin for implanted device patency
  • Requirement for concomitant therapy with drugs that prolong or may prolong QTc interval

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Dayton, Ohio, 45409

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Norfolk, Virginia, 85258

  • Study site

    Ocoee, Florida, 34761

  • Study site

    Tyler, Texas, 75702

Other trials in United States

About this study

Official title: A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Pharmacodynamic Study of Intravenously Administered CNF1010 (17-(Allylamino)-17-demethoxy-geldanamycin [17-AAG]) in Patients With ZAP-70 Positive B-Cell Chronic Lymphocytic Leukemia (CLL)

The purpose of the study is to evaluate the effects of increasing doses of CNF1010 on pharmacodynamic markers and hematological response.

Being tested
CNF1010 (17-AAG)
Keywords
Chronic lymphocytic leukemia, CLL, ZAP-70, Hsp90 inhibitor
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • CNF1010 (17-AAG)Drug

What is being measured

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

  1. The minimal biologically active dose (MBAD)

  2. Safety and toxicity profile

  3. Pharmacokinetics (PK)

  4. Pharmacodynamics (PD)

  5. Clinical and hematological response

Timeline

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

  1. First posted27 Apr 2006 (estimated)
  2. Study startMay 2005
  3. Study completionMay 2007

Why it stopped: Discontinuation of program

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00319930
Sponsor's protocol ID
CNF1010-CLL-05001
Other IDs
110CL101
Status last verified
Mar 2010
First submitted
27 Apr 2006
Last updated
8 Mar 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CNF1010 (17-AAG) in people with Chronic Lymphocytic Leukemia, run by Biogen at 6 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 19 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: stopped early, as of the sponsor's last update on 8 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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?

The study was stopped early (reason given: Discontinuation of program). Results are not available in the source record.

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?

The minimal biologically active dose (MBAD). The study lists 5 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 NCT00319930.

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 8 Mar 2010.

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