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B-Cell Chronic Lymphocytic LeukemiaPhase 2NCT01144260

Study of Bafetinib as Treatment for Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

A Phase 2 study testing bafetinib in people with B-Cell Chronic Lymphocytic Leukemia, run by CytRx at 2 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

A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Chronic Lymphocytic Leukemia
What is being tested?
bafetinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
Jun 2010to Apr 2013
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

  • Age ≥18 years, male or female.
  • B-cell chronic lymphocytic leukemia meeting the WHO criteria.
  • Relapsed or refractory disease with at least one of the following criteria: *progression after at least one course of a purine nucleoside analog (fludarabine phosphate, cladribine, pentostatin)
  • progression after at least one course of an alkylating agent (cyclophosphamide or chlorambucil)
  • relapse within 12 months after at least one course of either a purine nucleoside or an alkylating agent.
  • Capable of providing informed consent and complying with trial procedures.
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  • ECOG performance status 0-2.
  • Requires chemotherapy for disease as shown by any of the following criteria:
  • measurable and progressive lymphocytosis
  • measurable and progressive lymphadenopathy (lymph node ≥2 cm in a single diameter)
  • either weight loss ≥10% within the past 6 months or extreme fatigue due to leukemia
  • fevers ≥100.5 degrees F for 2 weeks with no source of infection
  • night sweats with no evidence of infection
  • progressive marrow failure (worsening anemia with hemoglobin <10 gm/dL and/or thrombocytopenia with platelet count <100,000/mm3)
  • massive or progressive splenomegaly (spleen >6 cm below left costal margin).
  • Women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. [Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.]
  • Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
  • Accessibility to the site.

Who cannot join

  • Chemotherapy, antibody therapy, surgery within 4 weeks of study enrollment.
  • Exposure to any investigational agent within 30 days of the Screening Visit.
  • Known CNS disease.
  • Concurrent active malignancies except basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix.
  • Laboratory values: Screening creatinine clearance (calculated by Cockcroft Gault formula) of less than 50 mL/minute, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count <3500/mm3, absolute neutrophil count <1000/mm3, hematocrit level <33% for females or <35% for males.
  • Clinically evident congestive heart failure >class II of the New York Heart Association (NYHA) guidelines.
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  • Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
  • History or signs of active coronary artery disease with or without angina pectoris.
  • Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram) or ultrasound determined absolute left ventricular ejection fraction (LVEF) <45% of predicted.
  • Known HIV infection.
  • Uncontrolled active, infection.
  • Major surgery within 3 weeks prior to treatment.
  • Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
  • Any condition that in the opinion of the Investigator is unstable and could jeopardize the subject's participation in the study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • City of Hope National Medical Center

    Duarte, California, 91010

  • UT M.D. Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Pilot Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL).

Read the detailed description

Bafetinib is a dual protein kinase inhibitor, targeting both bcr/abl and Lyn kinases. B-cell chronic lymphocytic leukemia cells overexpress Lyn kinase compared to normal B lymphocytes as well as acute leukemias (ALL and AML), and inhibition of Lyn kinase induces apoptosis in cultures of B-CLL cells. Thus, bafetinib may stop the growth of B-CLL cells by inhibiting Lyn kinase, the molecule that couples the B cell receptor to downstream signaling.

Being tested
bafetinib
Keywords
CLL, leukemia, chronic lymphocytic leukemia
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia

What participants receive

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

  • bafetinibDrug

    Also called INNO-406

    250 mg orally twice daily. Treatment continues until clinically significant disease progression or unacceptable toxicity is documented.

Study groups in NCT01144260
Study groupRoleWhat they receive
BafetinibExperimentalNot described
Receives: Drug: bafetinib

What is being measured

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

  1. To evaluate the response rate (complete and partial), in subjects with relapsed or refractory B-Cell CLL

    Measured: Upto 6 months or disease progression

Secondary outcomes (1)

  1. Adverse Events

    Measured: 1 year

Timeline

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

  1. First posted15 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2011
  4. Study completionApr 2013

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01144260
Sponsor's protocol ID
BAFETINIB-P2-CLL-01
Status last verified
May 2013
First submitted
9 Jun 2010
Last updated
15 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bafetinib in people with B-Cell Chronic Lymphocytic Leukemia, run by CytRx at 2 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 18 inclusion and 14 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 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

To evaluate the response rate (complete and partial), in subjects with relapsed or refractory B-Cell CLL (time frame: Upto 6 months or disease progression). 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 NCT01144260.

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 May 2013.

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