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Chronic Lymphocytic LeukemiaPhase 2NCT00413478

5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia

A Phase 2 study testing 5-Azacytidine in people with Chronic Lymphocytic Leukemia and Leukemia, run by M.D. Anderson Cancer Center at 1 site 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 objective of this study is to determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and T-cell prolymphocytic leukemia (T-PLL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia, Leukemia
What is being tested?
5-Azacytidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
Sep 2006to Nov 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, Richter's transformation or T-PLL who have previously been treated with fludarabine or another regime are eligible.
  • Patients with histologically or cytologically confirmed Richter's transformation.
  • Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than x 2 normal levels.
  • Women of childbearing potential who have a negative pregnancy test prior to azacytidine treatment.
  • Women of childbearing potential who agreed not to become pregnant and men agreed not to father a child while on azacytidine treatment.
  • Performance 0-2 (ECOG). Adequate liver function (bilirubin of less than2mg/dl) and renal function (creatinine less than 2mg/dl). Adequate cardiac functions (NYHA cardiac III-IV excluded).
  • Signed informed consent.

Who cannot join

  • Breast feeding or pregnant females. Patients of (male and female) childbearing potential should practice effective methods of contraception; otherwise, they will be excluded. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Known or suspected hypersensitivity to azacytidine or Mannitol.
  • Active and uncontrolled infections.
  • Patients with advanced malignant hepatic tumors.
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Study of 5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia

The objective of this study is to determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and T-cell prolymphocytic leukemia (T-PLL).

Read the detailed description

Azacytidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have blood drawn (about 3 teaspoons) to check your kidney and liver function (routine blood tests). You may have a bone marrow aspiration performed (if you have not had one in recent weeks). To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative urine pregnancy test.

If you agree to take part in this study, you will receive azacytidine by subcutaneous (just under the skin) injection every day for 7 days. This course of treatment will be repeated every 3-8 weeks, depending on the results of your routine blood tests.

Your doctor may increase or decrease your dose of azacytidine, depending on if you experience any side effects. You will continue to receive treatment on this study unless the disease gets worse or you experience any intolerable side effects. If the disease gets worse or you experience any intolerable side effects, you will be taken off this study.

This is an investigational study. This is an investigational study. Azacytidine has been approved by the FDA for the treatment of myelodysplastic syndrome. Up to 37 patients will take part in this study. All will be enrolled at M. D. Anderson.

Being tested
5-Azacytidine
Keywords
5-Aza, Azacytidine, Vidaza, CLL, Chronic Lymphocytic Leukemia, Richter's transformation, 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.

  • 5-AzacytidineDrug

    Also called Azacytidine, Vidaza, 5-aza, 5-AZC

    Starting dose level: 75mg/m^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.

Study groups in NCT00413478
Study groupRoleWhat they receive
5-AzacytidineExperimental5-Azacytidine 75mg/m^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.
Receives: Drug: 5-Azacytidine

What is being measured

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

  1. Tumor Response Rate (Complete, Partial) of Azacytidine

    Overall response rate includes percentage of participants with complete response (CR) plus partial response (PR) responses using the National Cancer Institute (NCI) International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for response: Complete response defined as no palpable lymph nodes, liver or spleen and absence of symptoms. Neutrophil count > 15,00/Mic L, and platelet count more than 100,000/MicL. Hemoglobin should be > 11g/dl without transfusions. Lymphocyte count <4000/micL. On bone marrow aspirate lymphocyte % should be <30%, and biopsy showing no lymphocyte infiltrate. A partial response was defined as more than or equal to 50% decrease in lymph nodes and liver and spleen size. Neutrophils > 1500/ micL or >50 % improvement from baseline, platelet count >100,000/micL or >50 % improvement from baseline. Hemoglobin >11g/dl or >50% improvement from baseline. A reduction of >50% in Leukocyte count or <30 % lymphocytes with residual disease on biopsy for nodular PR.

    Measured: 3 to 8 weeks treatment cycles, continuation up to 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 posted19 Dec 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionNov 2014
  4. Study completionNov 2014

Why it stopped: Slow accrual.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00413478
Sponsor's protocol ID
2006-0428
Other IDs
NCI-2010-00552
Status last verified
Jun 2015
First submitted
15 Dec 2006
Last updated
30 Jun 2015
Data monitoring committee
No

Publications

  • Malik A, Shoukier M, Garcia-Manero G, Wierda W, Cortes J, Bickel S, Keating MJ, Estrov Z. Azacitidine in fludarabine-refractory chronic lymphocytic leukemia: a phase II study. Clin Lymphoma Myeloma Leuk. 2013 Jun;13(3):292-5. doi: 10.1016/j.clml.2012.11.009. Epub 2012 Dec 21.

    PubMed 23265768

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5-Azacytidine in people with Chronic Lymphocytic Leukemia and Leukemia, run by M.D. Anderson Cancer Center at 1 site 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 7 inclusion and 5 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 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 30 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Tumor Response Rate (Complete, Partial) of Azacytidine (time frame: 3 to 8 weeks treatment cycles, continuation up to 1 year). 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 NCT00413478, 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 30 Jun 2015.

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