Donor Stem Cell Transplant After Conditioning Therapy in Treating Patients With Hematologic Cancer, Recurrent or Metastatic Solid Tumor, or Other Disease

Lymphoma Clinical Trial

Official title:

NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521430
• Other study ID #: CDR0000561542
• Secondary ID: AMC-UUCM-2004-00
• Status: Completed
• Phase: N/A
• First received: August 24, 2007
• Last updated: March 25, 2013
• Start date: April 2004
• Est. completion date: September 2008

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and methotrexate before and after transplant may stop this from happening.

PURPOSE: This clinical trial is studying the side effects and how well donor stem cell transplant works when given after conditioning therapy in treating patients with hematologic cancer, recurrent or metastatic solid tumor, or other disease.

Description:

OBJECTIVES:

• Determine the safety and efficacy of non-T-cell depleted, HLA-haploidentical related donor hematopoietic stem cell transplantation after a reduced-intensity conditioning regimen comprising busulfan, fludarabine phosphate, anti-thymocyte globulin, and methylprednisolone in patients with hematologic cancer, recurrent or metastatic solid tumors, or other diseases.

OUTLINE:

• Reduced-intensity conditioning regimen: Patients receive busulfan IV 4 times daily on days -7 and -6; fludarabine phosphate IV over 30 minutes on days -7 to -2; and methylprednisolone IV over 30 minutes followed by anti-thymocyte globulin IV over 4 hours on days -4 to -1.

• Donor hematopoietic stem cell transplantation: Patients receive donor peripheral blood stem cells IV over 1 hour on days 0 and 1.

• Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2-4 hours or orally twice daily beginning on day -1 and continuing until day 60, followed by a taper in the absence of GVHD. Patients also receive methotrexate IV on days 2, 4, 7, and 12.

After the transplant, patients are followed periodically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• High-risk acute leukemia, including any of the following:

• Refractory acute leukemia

• Acute leukemia beyond first remission

• Acute leukemia in first remission with poor prognostic features (e.g., chromosomal changes suggesting poor prognosis)

• Chronic myelogenous leukemia in second chronic, accelerated, or blastic phase

• Severe aplastic anemia that is not responsive to immunosuppressive therapy

• Myelodysplastic syndromes, including any of the following:

• Refractory anemia (RA) or RA with ringed sideroblasts with severe cytopenia

• RA with excess blasts (RAEB)

• RAEB in transformation

• Chronic myelomonocytic leukemia

• Refractory or relapsed non-Hodgkin or Hodgkin lymphoma

• Multiple myeloma

• Biopsy proven measurable solid tumor meeting 1 of the following criteria:

• Recurrent disease after primary treatment and deemed incurable to standard treatment

• Metastatic disease for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists

• Must have a related HLA-haploidentical mismatched (3/6 or fewer loci) donor available

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Bilirubin < 2.0 mg/dL

• AST < 3 times upper limit of normal

• Creatinine < 2.0 mg/dL

• Ejection fraction > 40% by MUGA

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Neoplasms
• Neoplasms, Plasma Cell
• Nonmalignant Neoplasm
• Plasmacytoma
• Preleukemia
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• anti-thymocyte globulin

Drug:
• busulfan

• cyclosporine

• fludarabine phosphate

• methotrexate

• methylprednisolone

Procedure:
• allogeneic hematopoietic stem cell transplantation

• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center - University of Ulsan College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & 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 transplant — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engraftment (neutrophil, platelet, and red blood cells)			No
Primary	Frequency and kinetics of mixed chimerism as assessed by polymerase chain reaction			No
Primary	Frequency and severity of regimen-related toxicities			Yes
Primary	Frequency of acute and chronic graft-versus-host disease			No
Primary	Immune reconstitution			No
Secondary	Tumor response rate			No
Secondary	Duration of tumor response			No
Secondary	Survival			No