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Autologous Peripheral Blood Stem Cell Transplantation (PSCT) Versus a Second Intensive Consolidation Course After a Common Induction and Consolidation Course in Patients With Bad Prognosis Myelodysplastic Syndromes (MDS) and Acute Myelogenous Leukemia Secondary (SAML) to MDS of More Acute Than 6 Months Duration


Phase 3
16 Years
60 Years
Open (Enrolling)
Both
Leukemia, Myelodysplastic Syndromes

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Trial Information

Autologous Peripheral Blood Stem Cell Transplantation (PSCT) Versus a Second Intensive Consolidation Course After a Common Induction and Consolidation Course in Patients With Bad Prognosis Myelodysplastic Syndromes (MDS) and Acute Myelogenous Leukemia Secondary (SAML) to MDS of More Acute Than 6 Months Duration


OBJECTIVES:

- Assess the value of autologous peripheral stem cell transplantation versus high dose
cytarabine (Ara-C) performed after a common induction and consolidation course in
patients with poor prognosis myelodysplastic syndromes (MDS) or acute myelogenous
leukemia secondary to MDS.

- Compare the disease free survival and overall survival of patients who reached complete
recovery according to the presence of an HLA-identical donor.

- Monitor cytogenetic and clonal remission after intensive antileukemic therapy including
stem cell transplantation.

- Monitor residual disease and the hematopoietic clonal status of autologous peripheral
blood stem cells mobilized after one consolidation course.

- Assess recovery time of granulocyte and platelet counts following each treatment step.

OUTLINE: Induction treatment with idarubicin on days 1,3,5; Ara-C from days 1 through 10;
etoposide on days 1 through 5. On day 28 there will be assessment of responses. If there is
at least partial response, the cycle will repeat the induction course for another 28 days.
There is peripheral blood stem cell collection and cryopreservation following family
HLA-typing. If there is no HLA match, then those who remained in remission after these
consolidation courses will be randomized to either peripheral blood stem cell
transplantation or HiDAC treatment.

PROJECTED ACCRUAL: 80 patients will be entered per year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Pathological confirmation of one of the following:

- Untreated refractory anemia with excess blasts (RAEB) in transformation

- RAEB with greater than 10% blasts cells in the bone marrow

- Other myelodysplastic syndromes

- Profound cytopenias

- Acute myelogenous leukemia (AML) supervening after overt myelodysplastic
syndromes (MDS) of more than 6 months duration

- No blast crisis of chronic myeloid leukemia

- No leukemias supervening after other myeloproliferative disease

- No leukemias supervening after overt MDS of less than 6 months duration

- The following are allowed:

- Secondary acute leukemias following Hodgkin's disease or other malignancies

- Secondary leukemias following exposure to alkylating agents or radiation

PATIENT CHARACTERISTICS:

Age:

- 16-60

Performance status:

- WHO 0-2

Hematopoietic:

- If RAEB, blasts cells of greater than 10% in bone marrow

- Neutrophil count less than 5,000 or Platelet count less than 200,000

- Chronic myelomonocytic leukemia (CMML) with greater than 5% blasts cells in bone
marrow, or CMML with neutrophil count greater than 160,000 or monocyte count greater
than 2,600

Hepatic:

- Bilirubin no greater than 1.5 times normal

Renal:

- Creatinine no greater than 1.5 times normal

Cardiovascular:

- No patients with severe heart failure requiring diuretics or an ejection fraction of
less than 50%

Neurological:

- No severe concomitant neurological disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No treatments within the past 4 weeks of:

- Biological response modifiers AND/OR

- Low dose Ara-C

Chemotherapy:

- No prior intensive treatment for MDS or AML

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior treatment for MDS or AML

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Theo De Witte, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Universitair Medisch Centrum St. Radboud - Nijmegen

Authority:

United States: Federal Government

Study ID:

CDR0000065336

NCT ID:

NCT00002926

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • secondary acute myeloid leukemia
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • refractory cytopenia with multilineage dysplasia
  • childhood myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

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