S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
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| ClinicalTrials.gov Identifier: NCT00016419 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : March 6, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia Myelodysplastic Syndromes | Biological: anti-thymocyte globulin Drug: cyclosporine | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 130 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS) |
| Study Start Date : | August 2001 |
| Actual Primary Completion Date : | July 2003 |
| Actual Study Completion Date : | January 2007 |
- Biological: anti-thymocyte globulin
3.5 mg/kg/d IV over 12 hrs day 1
- Drug: cyclosporine
3 mg/kg bid days 5-94 then taper to 0 at day 124 PO
- total response [ Time Frame: after induction therapy is completed ]
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| Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016419
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| Study Chair: | Charles A. Schiffer, MD | Barbara Ann Karmanos Cancer Institute |
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00016419 |
| Other Study ID Numbers: |
S0020 S0020 ( Other Identifier: SWOG ) U10CA032102 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | March 6, 2015 |
| Last Verified: | March 2015 |
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refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts |
de novo myelodysplastic syndromes secondary myelodysplastic syndromes childhood myelodysplastic syndromes |
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Preleukemia Myelodysplastic Syndromes Syndrome Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms Cyclosporine Cyclosporins |
Antilymphocyte Serum Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors |