Donor Stem Cell Transplant With or Without Chemotherapy in Treating Children With Primary Myelodysplastic Syndrome

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether donor stem cell transplant is more effective with or without chemotherapy in treating primary myelodysplastic syndrome.

PURPOSE: This phase III trial is studying how well donor stem cell transplant given with chemotherapy works and compares it with donor stem cell transplant without chemotherapy in treating children with primary myelodysplastic syndrome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Working Group of MDS in Childhood
• Treatments: 6-Mercaptopurine; Cytarabine; Mercaptopurine

Criteria

DISEASE CHARACTERISTICS:

• Morphologically confirmed primary myelodysplastic syndromes (MDS)

• Diagnosed between July 1, 1998 and June 30, 2002

• No prior aplastic anemia

• No prior congenital bone marrow failure syndrome, such as:

• Fanconi's anemia

• Kostmann syndrome

• Shwachman syndrome

• Dyskeratosis congenital

• Amegakaryocytic thrombocytopenia

• Diamond-Blackfan anemia

• No Down syndrome

• None of the following cytogenetic or molecular abnormalities:

• t(8;21)(q22;q22)

• t(15;17)(q22;q12)

• inv(16)(p13;q22)

• No typical clinical and cytogenetic features of acute myeloid leukemia FAB M7 (i.e., acute megakaryocytic leukemia) with fewer than 30% blasts in bone marrow or peripheral blood

PATIENT CHARACTERISTICS:

Age

• Under 19

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Not specified

Renal

• Not specified

Other

• No other concurrent illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for MDS

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for MDS

Surgery

• Not specified