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Refractory Chronic Lymphocytic LeukemiaPhase 1NCT01251250

Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia

A Phase 1 study testing laboratory biomarker analysis, western blotting and gene expression analysis in people with Refractory Chronic Lymphocytic Leukemia and Stage II Chronic Lymphocytic Leukemia, run by Roswell Park Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Azadirachta indica may be an effective treatment for chronic lymphocytic leukemia. PURPOSE: This phase I trial is studying the side effects and best dose of Azadirachta indica in treating patients with chronic lymphocytic leukemia. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
laboratory biomarker analysis, western blotting and gene expression analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2010to Jul 2011
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

  • Patients must have a definitive diagnosis of CLL as defined by the IWCLL criteria
  • Patients may not have received any prior treatment for management of CLL; (no more than 30 patients with treatment naive disease will be included in this study)
  • Patients with advance stage disease (Rai Stage II-IV) may be included in this clinical trial if they refuse to take standard chemotherapeutic regimens
  • Patients with relapsed or relapsed/ resistant may be included in this clinical trial if they refuse to take standard chemotherapeutic regimens
  • Patients must understand and voluntarily sign an informed consent form
  • Have an ECOG Performance Status of =< 2 at study entry
Show all 15Show fewer
  • Able to adhere to the study visit schedule and other protocol requirements
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Hemoglobin >= 10g/dl
  • Platelets >= 50,000/mcl
  • Total bilirubin within normal institutional limits
  • AST (SGOT)/ ALT (SGPT) =< 2.5 X institutional ULN
  • Patients of childbearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
  • Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • Trying to conceive, pregnant or breast feeding female patients
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
  • Patients who are consuming other herbals or non-traditional therapies (i.e. green tea extracts and cumin) within the last 4 weeks(28 days) of initiating this clinical study; note: patient must have stopped herbal or other non-traditional therapies for CLL at least 28 days prior to initiating therapy on this study
  • Patients with high-risk cytogenetic (del 17p, del 11q) determined by FISH analysis
  • Prior organ transplant

About this study

Official title: Phase I Clinical Trial of Neem Leaf Extract for the Treatment of Chronic Lymphocytic Leukemia

RATIONALE: Azadirachta indica may be an effective treatment for chronic lymphocytic leukemia. PURPOSE: This phase I trial is studying the side effects and best dose of Azadirachta indica in treating patients with chronic lymphocytic leukemia.

Read the detailed description

PRIMARY OBJECTIVES: I. To determine the lowest dose of neem leaf extract (NLE) with antileukemic effect and acceptable toxicity in patients with chronic lymphocytic leukemia (CLL). II. Establish the safety and toxicity of NLE in patients with CLL. SECONDARY OBJECTIVES: I. Determine the efficacy of NLE in patients with CLL defined as overall clinical response (CR + PR) by the IWCLL criterion. II. To develop a pharmacokinetic/pharmacodynamic model relating neem leaf extract exposure to toxicity and pharmacodynamic endpoints in CLL patients that will allow personalized dosing to target optimal drug exposure. III. To conduct correlative studies. OUTLINE: This is a dose-escalation study. Patients receive oral Azadirachta indica once daily on days 1-28. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year.

Being tested
laboratory biomarker analysis, western blotting, gene expression analysis, pharmacological study, flow cytometry
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.

  • laboratory biomarker analysisOther

    Correlative studies

  • western blottingGenetic

    Also called Blotting, Western, Western Blot

    Correlative studies

  • gene expression analysisGenetic

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • flow cytometryOther

    Correlative studies

  • fluorescence in situ hybridizationGenetic

    Also called fluorescence in situ hybridization (FISH)

    Correlative studies

  • azadirachta indicaBiological

    Also called neem, neem tree

    Given orally

  • reverse transcriptase-polymerase chain reactionGenetic

    Also called RT-PCR

    Correlative studies

Study groups in NCT01251250
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral Azadirachta indica once daily on days 1-28. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Receives: Other: laboratory biomarker analysis; Genetic: western blotting; Genetic: gene expression analysis; Other: pharmacological study; Other: flow cytometry; Genetic: fluorescence in situ hybridization; Biological: azadirachta indica; Genetic: reverse transcriptase-polymerase chain reaction

What is being measured

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

  1. Lowest clinically active and tolerable dose

    Measured: After patients have completed at least 2 treatment courses

Timeline

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

  1. First posted1 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJul 2011

Why it stopped: lost sponsor support

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01251250
Sponsor's protocol ID
I 169009
Other IDs
NCI-2010-02103
Status last verified
Jan 2014
First submitted
30 Nov 2010
Last updated
13 Jan 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing laboratory biomarker analysis, western blotting and gene expression analysis in people with Refractory Chronic Lymphocytic Leukemia and Stage II Chronic Lymphocytic Leukemia, run by Roswell Park Cancer Institute.

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 15 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: withdrawn, as of the sponsor's last update on 13 Jan 2014. 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 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 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?

Lowest clinically active and tolerable dose (time frame: After patients have completed at least 2 treatment courses). 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 NCT01251250.

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 13 Jan 2014.

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