NCT00004904

Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Phase I Study of T Cell Depleted (TCD) Partially Matched Related Donor (PMRD) Hematopoietic Stem Cell Transplantation for High Risk Hematologic Diseases Using Intense Pre and Post Transplant Immunosuppression and Megadose CD34 "Veto" Cells

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of treated donor stem cell transplantation in treating patients who have hematologic cancer.

Detailed description

OBJECTIVES: I. Determine if megadose CD34 cells and intense immunosuppression administered before and after partially matched related donor (PMRD) hematopoietic stem cell (HSC) transplantation results in engraftment in patients with high risk hematologic malignancies. II. Determine the incidence and severity of acute grade (I-IV) and chronic (limited or extensive) graft versus host disease in patients after rigorous T-cell depletion in PMRD HSC transplantation. OUTLINE: Harvest: Bone marrow and peripheral blood stem cells (PBSC) are harvested from a related 1, 2, or 3 HLA antigen mismatched donor. PBSC are selected for CD34+ cells and T-cells are depleted. Conditioning: Patients undergo total body irradiation twice daily on days -10 to -7 and once on day -6. Patients receive cladribine IV continuously on days -10 to -6; etoposide IV over 2 hours on day -5; and cyclophosphamide IV over 2 hours, antithymocyte globulin (ATG) IV over 10-12 hours, and methylprednisolone IV over 1 hour on days -4 to -2. Transplantation: T-cell depleted PBSC and bone marrow are infused on day 0. Patients receive G-CSF SQ daily beginning on day 0 and continuing until blood counts recover. Graft versus host disease prophylaxis: Patients receive tacrolimus IV every 12 hours beginning on day -2 and continuing orally 4 times a day for 6-12 months at the discretion of the protocol investigator. Patients receive ATG IV over 10-12 hours and methylprednisolone IV over 1 hour on days 5-15 followed by a taper of methylprednisolone. Patients are followed every week through day 100 and then at 6 and 12 months. PROJECTED ACCRUAL: A total of 12-20 patients will be accrued for this study within 3 years.

Conditions

• Chronic Myeloproliferative Disorders
• Graft Versus Host Disease
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Precancerous/Nonmalignant Condition
• Small Intestine Cancer

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin
BIOLOGICAL	filgrastim
DRUG	cladribine
DRUG	cyclophosphamide
DRUG	etoposide
DRUG	methylprednisolone
DRUG	tacrolimus
PROCEDURE	allogeneic bone marrow transplantation
PROCEDURE	in vitro-treated peripheral blood stem cell transplantation

Timeline

• Start date: 1999-10-01
• Primary completion: 2000-07-01
• Completion: 2000-07-01
• First posted: 2004-03-03
• Last updated: 2012-06-04

Locations

1 site across 1 country: United States