AzTrials
AzTrials

Myelodysplastic SyndromePhase 2IMDS001NCT00704704

Safety and Efficacy of Azacitidine, and Thalidomide in Higher Risk MDS (Myelodysplastic Syndrome)

A Phase 2 study testing 5-aza-cytidine and Thalidomide in people with Myelodysplastic Syndrome, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Study Objectives The aim of the study is to evaluate the safety and efficacy of the combination of 5-Aza-Cytidine + Thalidomide on the course of hrMDS patients. Primary end point: To evaluate the overall response rate (CR+PR) of the combination of 5-Aza-Cytidine + Thalidomide in hrMDS patients (INT-2 and High risk as… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndrome
What is being tested?
5-aza-cytidine and Thalidomide
Type of treatment
Pill or oral medicine
How many people
50 participants
Where
1 siteIsrael
Study dates
Sep 2008to Apr 2011
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

  • Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
  • Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
  • Patient is older than 18 years at the time of signing the informed consent.
  • Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable double method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Female of childbearing potential must have a negative serum β-human chorionic gonadotropin ( beta sub unit-HCG) pregnancy test both 24 hours prior to beginning of therapy and then at 4 weeks intervals in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles during study treatment for subjects of childbearing potential.
  • Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of thalidomide therapy.
Show all 18Show fewer
  • Patient was diagnosed with myelodysplastic syndrome INT-2 or High risk according IPSS score .Bone marrow aspiration examination including cytogenetics performed up to 12 months before patient signing informed consent.
  • Patient has a Performance Status 0-2 (WHO).
  • Patient has a life-expectancy > 6 months
  • Patient has not known active infectious hepatitis type B or C, or HIV infection.
  • Patient is epopoietin resistant. Erythropoietin should be discontinued 28 days before starting treatment period.
  • Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1):
  • Platelet count ≥ 25 x 109/L without transfusion support within 7 days before the test.
  • Absolute neutrophil count (ANC) ≥ 0.5 x 109/L without the use of growth factors.
  • Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal (ULN).
  • Alanine transaminase (ALT): ≤ 2.5 x the ULN.
  • Total bilirubin: ≤ 1.5 x the ULN.
  • Serum creatinine< 2 X the ULN.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Moshe Mittelman, MD contact

972-3-6973366

moshemt@TASMC.HEALTH.GOV.IL

Elizabeth Naparstek, MD contact

972-524266435

enaparstek@tasmc.health.gov.il

Israel1 site

  • Hematolpgical department Tel Aviv Medical Center

    Tel Aviv

    Moshe Mittelman, MD, 972-3-6973366, moshemt@tasmc.health.gov.il

    972-52-4266435, enaparstek@tasmc.health.gov.il

Other trials in Israel

About this study

Official title: A Phase 2, Single Arm Study to Determine the Safety and Efficacy of Azacitidine, and Thalidomide in Higher Risk Myelodysplastic Syndrome

Study Objectives The aim of the study is to evaluate the safety and efficacy of the combination of 5-Aza-Cytidine + Thalidomide on the course of hrMDS patients.

Primary end point:

Read more
  • To evaluate the overall response rate (CR+PR) of the combination of 5-Aza-Cytidine + Thalidomide in hrMDS patients (INT-2 and High risk as defined by IPSS).

Secondary end points:

  • To evaluate the safety of the combination of Thalidomide+5-Aza-Cytidine in high risk MDS patients.
  • Hematological improvement rate.
  • Cytogenetic response.
  • Progression free survival (PFS).
  • Quality of life assessment (FACT: MDS and peripheral neuropathy QOL Questionnaires).

Study design:

This is a multicenter, phase II, single arm study designed to evaluate the safety and efficacy of the combination of Thalidomide+5-Aza-Cytidine in high risk MDS patients (INT-2 and High risk defined by IPSS) who are older than 18 years of age. Potential study subjects will sign an informed consent prior to undergoing any study related procedure. Number of patients to be enrolled 50.

Treatment plan: 5-aza-cytidine (75 mg m2/d) will be injected subcutaneously in 5-day cycle every 28 days, for a total of 12 cycles.

Thalidomide will be given at the dose of 50 mg/d, from day 1 until for 6 months together with 5-aza-cytidine .

Treatment period includes 5-aza-cytidine (75 mg m2/d) will be injected subcutaneously in 5-day cycle every 28 days. Total number of 12 cycles or until progression or toxicity. Cycle delay of maximum 2 weeks in case of hematological toxicity grade 3-4 at investigator discretion.

Duration of the follow up period is 6 months. Duration of study The duration of the treatment period is approximately 12 months. This time is required to complete the treatment, and to determine the safety profile and the response rate. The duration of the Follow period will be approximately a half year. The occurrence of PD will determine the duration of progression-free survival of each patient.

Being tested
5-aza-cytidine and Thalidomide
Keywords
high risk MDS, IPSS, 5-AZA-Cytidine, Thalidomide, response rate, cytogenetic response, QOL questionaries, INT-2 or High risk MDS
Medical subject headings
Myelodysplastic Syndromes

What participants receive

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

  • 5-aza-cytidine and ThalidomideDrug

    Also called vidaza

    5-AZA-Cytidine 75mg/m2 5 days a month. 12 months. Thalidomide 50mg orally daily for 6 months.

What is being measured

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

  1. overall response rate measured by complete blood counts and bone marrow examinations

    Measured: at study entry. after 6 months and after one year

  2. overall response rate

    Measured: 6 and 12 months

Secondary outcomes (1)

  1. *safety *hematological improvement *cytogenetic response *progression free survival * Quality of life assessment (FACT: MDS and peripheral neuropathy QOL Questionnaires).

    Measured: at entry , 6 and 12 months

Timeline

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

  1. First posted25 Jun 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionSep 2010 (estimated)
  4. Study completionApr 2011 (estimated)

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00704704
Sponsor's protocol ID
TASMC-08-MM-TLV-0069-08-CTIL
Acronym
IMDS001
Status last verified
Jun 2008
First submitted
23 Jun 2008
Last updated
25 Jun 2008
Results posted
No
Data monitoring committee
No

Publications

  • 1. Greenberg PL. Risk factors and their relationship to prognosis in myelodysplastic syndromes. Leuk Res. 1998;22 Suppl 1:S3-6. 2. Sanz GF, Sanz MA, Greenberg PL. Prognostic factors and scoring systems in myelodysplastic syndromes. Haematologica. 1998;83:358-368. 3. Hellstrom-Lindberg E, Ahlgren T, Beguin Y, et al. Treatment of anemia in myelodysplastic syndromes with granulocyte colony-stimulating factor plus erythropoietin: results from a randomized phase II study and long-term follow-up of 71 patients. Blood. 1998;92:68-75. 4. Silverman LR, Demakos EP, Peterson BL, et al. Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: a study of the cancer and leukemia group B. J Clin Oncol. 2002;20:2429-2440. 5. Silverman LR, McKenzie DR, Peterson BL, et al. Further analysis of trials with azacitidine in patients with myelodysplastic syndrome: studies 8421, 8921, and 9221 by the Cancer and Leukemia Group B. J Clin Oncol. 2006;24:3895-3903. 6.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5-aza-cytidine and Thalidomide in people with Myelodysplastic Syndrome, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

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 1 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: status not confirmed, as of the sponsor's last update on 25 Jun 2008. 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 Israel. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Moshe Mittelman, MD (972-3-6973366, moshemt@TASMC.HEALTH.GOV.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate measured by complete blood counts and bone marrow examinations (time frame: at study entry. after 6 months and after one year). 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 NCT00704704, 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 25 Jun 2008.

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