Donor Stem Cell Transplant After Busulfan, Fludarabine, and Antithymocyte Globulin in Treating Patients With Hematologic Cancer or Myelodysplastic Syndrome

NCT00732316 | Completed Phase 2

• 2 other identifiers: CDR0000600347AMC-UUCM-2008-0037
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving low doses of chemotherapy and antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer and abnormal cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying how well a donor stem cell transplant works after busulfan, fludarabine, and antithymocyte globulin in treating patients with hematologic cancer or myelodysplastic syndrome.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

accelerated phase chronic myelogenous leukemia; adult acute lymphoblastic leukemia in remission; adult acute myeloid leukemia in remission; acute undifferentiated leukemia; blastic phase chronic myelogenous leukemia; childhood acute lymphoblastic leukemia in remission; childhood acute myeloid leukemia in remission; childhood chronic myelogenous leukemia; childhood myelodysplastic syndromes; chronic phase chronic myelogenous leukemia; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; recurrent childhood acute lymphoblastic leukemia; recurrent childhood acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; recurrent adult acute myeloid leukemia; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; relapsing chronic myelogenous leukemia; secondary myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

• tumor response

  leukemia CR, CR duration

  about 4-8 weeks after transplantation

Secondary Outcomes (2)

• Donor cell engraftment (neutrophil, platelet, and red blood cells)

  10-35 days after transplantation

• Acute and chronic graft-versus-host disease

  15-100 days; 100 days to 4 years

Interventions

nonmyeloablative allogeneic hematopoietic stem cell transplantation PROCEDURE

administration of conditioning therapy including immunosuppressive agents plus alkylating agents and infusing hematopoietic progenitor cells collected from the donor

peripheral blood stem cell transplantation PROCEDURE

infusion of donor hematopoietic cells collected by leukapheresis after mobilization with growth factor

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following hematological malignancies: * Acute leukemia, including any of the following: * Refractory acute leukemia * Acute leukemia beyond first remission * Acute leukemia in first remission with intermediate to poor prognostic features as suggested by chromosomal findings * Chronic myelogenous leukemia (CML) * Second chronic phase * Accelerated phase * Blastic phase * Myelodysplastic syndrome (MDS) * High-risk MDS (refractory anemia with excess blasts \[RAEB\], RAEB in transformation, and chronic myelomonocytic leukemia) can be transplanted without prior therapy or after prior therapy failure with hypomethylating agents * Low-risk MDS can be considered for transplantation after prior therapy failure with immunosuppressive or hypomethylating agents * No willing, suitable HLA-matched donor in family or in donor registries * Patients with active hematologic malignancy, who are felt to be in urgent need of allogeneic hematopoietic cell transplantation, can enroll without a search for HLA-matched unrelated donors * Related donor with HLA-haploidentical mismatch at 3 or less of 6 loci available PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Bilirubin \< 2.0 mg/dL * Creatinine \< 2.0 mg/dL * AST \< 3 times upper limit of normal * Ejection fraction \> 40% by MUGA PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Asan Medical Center: lead
• Pusan National University Hospital: collaborator

Study Sites (1)

Asan Medical Center - University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

Related Publications (1)

• Lee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Hwang HJ, Jung AR, Kim SH, Yun SC, Shin HJ. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011 Sep 1;118(9):2609-17. doi: 10.1182/blood-2011-02-339838. Epub 2011 Jun 28.

  PMID: 21715313 RESULT

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Leukemia, Myeloid, Accelerated Phase; Leukemia, Biphenotypic, Acute; Blast Crisis; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelomonocytic, Chronic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Anemia, Refractory, with Excess of Blasts

Interventions

Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Myelodysplastic-Myeloproliferative Diseases; Anemia, Refractory; Anemia

Intervention Hierarchy (Ancestors)

Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Kyoo H. Lee, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 11, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2011
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

KR (1)