Allogeneic Peripheral Stem Cell Transplantation Followed By Donor Lymphocyte Infusions in Treating Patients With Hematologic Cancer

Lymphoma Clinical Trial

Official title: Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed By T Cell Add-Back For Hematological Malignancies - Effect Of Irradiated Donor Lymphocytes On Chimerism

Status Active, not recruiting

Clinical Trial Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Eliminating the T cells from the donor cells before transplanting them may prevent this from happening. Infusions of donor lymphocytes may decrease the body's rejection of the transplanted peripheral stem cells.

PURPOSE: Phase II trial to study the effectiveness of allogeneic stem cell transplantation followed by donor lymphocyte infusions in treating patients who have hematologic cancer.

Clinical Trial Description

OBJECTIVES:

• Determine the effect of irradiated donor T-cell infusion on donor T-cell chimerism 6 weeks after hematopoietic stem cell transplantation in patients with hematologic malignancies.

• Determine the infusional toxic effects of irradiated donor lymphocytes in these patients.

• Determine the risk of acute and chronic graft-versus-host disease from donor lymphocyte infusions on day 45 and day 100 posttransplantation in HLA 6/6 matched transplantations from a related donor in these patients.

• Determine disease-free survival, cytomegalovirus reactivation, and relapse in patients treated with this regimen.

• Determine transplant-related mortality and death from all causes in patients treated with this regimen.

OUTLINE:

• Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo total body irradiation on days -7 to -4.

• Pretransplantation irradiated donor lymphocyte infusion (DLI): Patients receive irradiated DLI on day -4.

• Hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT on day 0.

• Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine on days 44-120.

• Posttransplantation DLI: Patients receive DLI on days 45 and 100. Patients with chronic myelogenous leukemia in chronic phase who are polymerase chain reaction negative for bcr/abl receive DLI on day 45 only.

Patients are followed at 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study. ;

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Preleukemia

• NCT number: NCT00066300
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 2003