Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002926
First received: November 1, 1999
Last updated: May 26, 2010
Last verified: May 2001
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Drug: cytarabine
Drug: etoposide
Drug: idarubicin
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 80
Study Start Date: December 1996
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002926

  Show 40 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Theo De Witte, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002926     History of Changes
Other Study ID Numbers: CDR0000065336, EORTC-06961
Study First Received: November 1, 1999
Last Updated: May 26, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cytarabine
Etoposide
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 29, 2014