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B-cell Chronic Lymphocytic LeukemiaPhase 2NCT00918450

Study Assessing the Safety and Efficacy of ABT-263 in Subjects With B-cell Chronic Lymphocytic Leukemia (CLL) Who Have Failed at Least One Prior Fludarabine-containing Regimen

A Phase 2 study testing ABT-263 in people with B-cell Chronic Lymphocytic Leukemia, run by Abbott.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a Phase 2b, open-label, multicenter, global study assessing the safety and efficacy of ABT-263 in subjects with B-cell CLL who have failed at least one prior fludarabine-containing regimen. 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?
ABT-263
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
Mar 2010to Dec 2012
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

  • >= 18 yrs of age, have B-cell CLL, failed at least 1 prior fludarabine-containing regimen.
  • Refractory to 1 fludarabine-containing regimen is defined as failure to achieve at least PR to the last fludarabine-containing regimen received, or disease progression while receiving the last fludarabine-containing regimen, or disease progression in responders (i.e., achieved a PR or CR) within 6 mos of the last cycle of the last fludarabine-containing regimen received (e.g., fludarabine monotherapy, FR, or FC) or in responders (i.e., achieved a PR or CR ) within 24 mos of the last cycle of FCR.
  • Intolerant to fludarabine is defined as discontinuation of therapy within 2 cycles due to side effects/toxicity from the last fludarabine-containing regimen.
  • ECOG score of <=1.
  • Adequate coagulation, renal, \& hepatic function at Screening as follows:
  • Serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min;
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  • AST \& ALT <= 3.0 x ULN;
  • Bilirubin <= 1.5 x ULN.
  • Gilbert's Syndrome may have a Bilirubin > 1.5 x ULN; aPTT, PT, not to exceed 1.2 x ULN.
  • Adequate bone marrow (BM) independent of any growth factor support (with the exception of subjects with BM heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve adequate BM) at Screening as follows:
  • ANC >= 1000/µL;
  • Platelets >= 75,000/mm3 (entry platelet count must be independent of transfusion within 14 days of Screening);
  • Hemoglobin >= 9.0 g/dL.
  • History of autologous BM transplant must be > 6 mos post transplant (prior to the 1st dose of study drug) \& have adequate BM independent of any growth factor support (with the exception of subjects with BM that is heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve adequate BM) at Screening as follows:
  • ANC >= 1500/µL;
  • Platelets >= 125,000/mm3;
  • Hemoglobin >= 10.0 g/dL.
  • Female subjects must be surgically sterile, postmenopausal (at least 1 year), or have negative results on a pregnancy test.
  • All female subjects not surgically sterile or postmenopausal (at least 1 year) \& non-vasectomized male subjects must practice birth control.

Who cannot join

  • History/clinically suspicious for cancer-related CNS disease.
  • Undergone allogeneic stem cell transplant.
  • Undergone autologous stem cell transplant w/i 6 mos prior to 1st dose.
  • History/predisposing condition of bleeding or currently exhibits signs of bleeding.
  • Recent history of non-chemotherapy induced thrombocytopenic associated bleeding w/i 6 mos prior to 1st dose.
  • Active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
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  • Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions w/i 1 yr prior to 1st dose.
  • Currently receiving/requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications used to maintain the patency of a central IV catheter.
  • Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease.
  • Positive for HIV, Hepatitis B, or Hepatitis C.
  • Previous or current malignancies w/i the last 3 yrs:
  • except adequately treated in situ carcinoma of the cervix uteri;
  • basal or squamous cell carcinoma;
  • in situ carcinoma of the bladder;
  • or previous malignancy confined and surgically resected with curative intent.
  • Has Prolymphocytic leukemia or Richter's transformation to an aggressive B-cell malignancy.
  • Exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled systemic infection or diagnosis of fever and neutropenia w/i 1 week prior to study drug.
  • Prior exposure to ABT-263.
  • Received antibody therapy w/i 30 days prior to 1st dose.
  • Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, or any investigational therapy w/i 14 days prior to the 1st dose, or has not recovered to <Gr2 clinically significant AE(s) /toxicity(s) of the previous therapy.
  • Received steroid therapy for anti-neoplastic intent, w/i 7 days prior to the 1st dose with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids.
  • Received aspirin w/i 7 days prior to the 1st dose.
  • Consumed grapefruit or grapefruit products w/i 3 days prior to 1st dose.
  • Females pregnant or breast-feeding.

About this study

Official title: A Phase 2b Monotherapy Study of ABT-263 in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

This is a Phase 2b, open-label, multicenter, global study assessing the safety and efficacy of ABT-263 in subjects with B-cell CLL who have failed at least one prior fludarabine-containing regimen.

Being tested
ABT-263
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.

  • ABT-263Drug

    Continuous dosing until disease progression using one of the following formulations:

    25 mg/mL oral solution OR 50 mg/mL oral solution OR 2.0 grams/bottle powder for oral solution of 25 mg/mL when mixed OR 2.0 grams/bottle powder for oral solution of 50 mg/mL when mixed

Study groups in NCT00918450
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: ABT-263

What is being measured

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

  1. Assess the safety of ABT-263 by evaluating study drug exposure, adverse events, serious adverse events, all deaths, as well as changes in laboratory determinations and vital sign parameters.

    Measured: monthly (at a minimum)

  2. Assess the objective response rate (partial response [PR] and confirmed complete response [CR]) of B-cell CLL subjects treated with ABT-263.

    Measured: Every 3 months

Secondary outcomes (3)

  1. Assess the effects of ABT-263 on duration of overall response, PFS and overall survival in subjects with B-cell CLL.

    Measured: Every 3 months

  2. Assess the effects of ABT-263 on time to response, 12-month survival rate, time to disease progression (TTP), and disease control rate in subjects with B-cell CLL .

    Measured: Every 3 months

  3. Investigate the effects of ABT-263 on quality of life (FACT-Leu and EQ-5D), ECOG performance status, and biomarkers in subject with B-cell CLL.

    Measured: Every 3 months

Timeline

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

  1. First posted11 Jun 2009 (estimated)
  2. Study startMar 2010
  3. Primary completionDec 2012 (estimated)

Why it stopped: Sponsor has decided to not proceed with this study.

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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00918450
Sponsor's protocol ID
M10-738
Status last verified
Feb 2010
First submitted
22 May 2009
Last updated
26 Feb 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-263 in people with B-cell Chronic Lymphocytic Leukemia, run by Abbott.

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 24 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: withdrawn, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Assess the safety of ABT-263 by evaluating study drug exposure, adverse events, serious adverse events, all deaths, as well as changes in laboratory determinations and vital sign parameters. (time frame: monthly (at a minimum)). The study lists 2 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 NCT00918450.

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 26 Feb 2010.

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