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LeukemiaPhase 2NCT00016419

S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome

A Phase 2 study testing anti-thymocyte globulin and cyclosporine in people with Leukemia and Myelodysplastic Syndromes, run by SWOG Cancer Research Network at 94 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

RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be an effective treatment for myelodysplastic syndrome. PURPOSE: Phase II trial to study the effectiveness of antithymocyte globulin plus cyclosporine in treating patients who have myelodysplastic syndrome. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Leukemia, Myelodysplastic Syndromes
What is being tested?
anti-thymocyte globulin and cyclosporine
Type of treatment
Injection or infusion
How many people
130 participants
Where
94 sitesUnited States
Study dates
Aug 2001to Jan 2007
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Morphologically confirmed myelodysplastic syndromes (MDS)
  • Refractory anemia (RA)
  • RA with ringed sideroblasts
  • RA with excess blasts
  • Low, intermediate-1, or intermediate-2 risk by International Prognostic Scoring System criteria
  • MDS secondary to prior chemotherapy and/or radiotherapy for other malignant disorders allowed
  • Must have received prior transfusions of at least 4 units of red blood cells for anemia within the past 60 days
  • Must be concurrently registered on SWOG-S9910 and SWOG-9007
  • Ineligible for or refused participation in SWOG-S9920 (HLA-identical sibling peripheral blood stem cell transplantation)

PATIENT CHARACTERISTICS:

Age:

  • 15 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
  • HIV negative
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • Prior cytokines (e.g., interferon or interleukin), colony-stimulating factors, or epoetin alfa allowed
  • No prior bone marrow or stem cell transplantation
  • No concurrent growth factors (including epoetin alfa) except filgrastim (G-CSF) or sargramostim (GM-CSF) for neutropenia

Chemotherapy:

  • See Disease Characteristics
  • No prior remission induction chemotherapy for MDS
  • Prior hydroxyurea allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified

Other:

  • Prior amifostine allowed
  • No calcium-channel blockers (diltiazem, nicardipine, or verapamil), antifungals (fluconazole, itraconazole, or ketoconazole), antibiotics (clarithromycin or erythromycin), or other drugs (bromocriptine or danazol) that would increase cyclosporine concentrations for 48 hours before, during, and for 48 hours after cyclosporine
  • No antibiotics (nafcillin or rifampin) or anticonvulsants (carbamazepine, phenobarbital, or phenytoin) that would decrease cyclosporine concentrations for 14 days before and during cyclosporine

Trial locations and contacts

94 sites in 1 country.

94 sites in 1 country

United States94 sites

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0912

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi, 39531-2410

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina, 29401-5799

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612-7323

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Barrett Cancer Center

    Cincinnati, Ohio, 45267-0501

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-9001

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Genesis Medical Center

    Davenport, Iowa, 52804

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois, 60141

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813-2424

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • Veterans Affairs Medical Center - Houston

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7353

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40502-2236

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas, 72205

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Veterans Affairs Medical Center - West Los Angeles

    Los Angeles, California, 90073

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Loyola University Medical Center

    Maywood, Illinois, 60153-5500

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • MBCCOP - LSU Medical Center

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma, 73104

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • CCOP - Greater Phoenix

    Phoenix, Arizona, 85006-2726

  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

    Phoenix, Arizona, 85012

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • CCOP - Columbia River Program

    Portland, Oregon, 97225

  • Oregon Cancer Institute

    Portland, Oregon, 97239

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112-5550

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7845

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78284

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71130

  • Providence Hospital - Southfield

    Southfield, Michigan, 48075-9975

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • MBCCOP - Howard University Cancer Center

    Washington D.C., District of Columbia, 20060

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

Other trials in United States

About this study

Official title: A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)

RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be an effective treatment for myelodysplastic syndrome.

PURPOSE: Phase II trial to study the effectiveness of antithymocyte globulin plus cyclosporine in treating patients who have myelodysplastic syndrome.

Read the detailed description

OBJECTIVES:

  • Determine the response in patients with myelodysplastic syndromes treated with anti-thymocyte globulin and cyclosporine.
  • Determine the frequency and severity of toxic effects of this regimen in these patients.
  • Assess the correlation between response to treatment and the in vitro assessment of T-lymphocyte subsets in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to myelodysplastic syndrome subclassification (refractory anemia [RA] vs RA with ringed sideroblasts vs RA with excess blasts).

Patients receive induction therapy comprising anti-thymocyte globulin IV over 6-12 hours on days 1-4 and oral cyclosporine twice daily on days 5-94 followed by a taper until day 124. Patients who relapse after a response of at least 60 days may receive reinduction therapy comprising oral cyclosporine twice daily on days 1-90 followed by a taper until day 120. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 6 months, every 2 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 130 patients (53 with refractory anemia [RA], 33 with RA with ringed sideroblasts, and 44 with RA with excess blasts) will be accrued for this study within 14-22 months.

Being tested
anti-thymocyte globulin, cyclosporine
Keywords
refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, childhood myelodysplastic syndromes
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Anemia, Refractory, Anemia, Refractory, with Excess of Blasts

What participants receive

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

  • anti-thymocyte globulinBiological

    3.5 mg/kg/d IV over 12 hrs day 1

  • cyclosporineDrug

    3 mg/kg bid days 5-94 then taper to 0 at day 124 PO

What is being measured

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

  1. total response

    Measured: after induction therapy is completed

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2001
  3. Primary completionJul 2003
  4. Study completionJan 2007

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
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00016419
Sponsor's protocol ID
S0020
Other IDs
S0020, U10CA032102
Status last verified
Mar 2015
First submitted
6 May 2001
Last updated
6 Mar 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-thymocyte globulin and cyclosporine in people with Leukemia and Myelodysplastic Syndromes, run by SWOG Cancer Research Network at 94 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?

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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 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?

total response (time frame: after induction therapy is completed). 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 NCT00016419.

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 6 Mar 2015.

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