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Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation

This study is not yet open for patient recruitment.

Sponsored by: Fred Hutchinson Cancer Research Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Biological therapies work in different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells in patients undergoing donor stem cell transplantation.

PURPOSE: Phase I/II trial to study the effectiveness of biological therapy in treating patients with advanced acute myeloid leukemia or acute lymphoblastic leukemia.

Condition Treatment or Intervention Phase
adult acute lymphoblastic leukemia
adult acute myeloid leukemia
childhood acute lymphoblastic leukemia
childhood acute myeloid leukemia and other myeloid malignancies
secondary acute myeloid leukemia
 Drug: allogeneic lymphocytes
 Drug: interleukin-2
 Procedure: allogeneic bone marrow transplantation
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: bone marrow transplantation
 Procedure: cytokine therapy
 Procedure: interleukin therapy
 Procedure: leukocyte therapy
 Procedure: peripheral blood lymphocyte therapy
 Procedure: peripheral blood stem cell transplantation
Phase I
Phase II

MedlinePlus related topics:  Bone Marrow Diseases;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Pilot Study of Adoptive Immunotherapy Comprising CD8-Positive Wilms' Tumor (WT1) Gene-Specific Cytotoxic T-Lymphocyte Clones and Interleukin-2 in Patients With HLA-A2 or HLA-A24-Positive Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia At High Risk for Relapse After Allogeneic Stem Cell Transplantation

Further Study Details: 

OBJECTIVES:

OUTLINE: Donors undergo leukapheresis or peripheral blood draw for stem cell harvest to generate CD8-positive Wilms' tumor (WT1) gene-specific cytotoxic T-lymphocyte (CTL) clones before allogeneic stem cell transplantation.

After post-transplantation hematopoietic recovery, patients receive treatment for either highest-risk disease (prophylactically) or relapsed disease.

Patients are followed until day 90, at day 180, and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study within 3-5 years.

Eligibility

Ages Eligible for Study:  up to  75 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

Performance status

Life expectancy

Hematopoietic

Hepatic

Renal

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

Radiotherapy

Surgery


Location Information


Study chairs or principal investigators

William Y. Ho, MD,  Study Chair,  Fred Hutchinson Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000258507; FHCRC-1655.00
Record last reviewed:  January 2004
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052520
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20
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