Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell Transplantation

Phase 1

Completed

• Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Leukemia; Lymphoma; Myelodysplastic Syndromes

• Registration Number: NCT00005946
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. White blood cells from donors may be able to prevent graft-versus-host disease in patients with hematologic cancer that has relapsed following donor peripheral stem cell transplantation.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus donor white blood cell infusion in treating patients who have relapsed hematologic cancer following donor peripheral stem cell transplantation.

Detailed Description

OBJECTIVES: I. Determine the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60% graft versus host disease in patients with hematologic malignancies relapsed after allogeneic stem cell transplantation.

OUTLINE: This is a dose de-escalation study. Patients receive etoposide IV continuously on days 1-3; cyclophosphamide IV on day 8; donor lymphocyte infusion IV on day 10; and filgrastim (G-CSF) subcutaneously or IV beginning on day 10 and continuing until blood counts recover. Cohorts of 3-6 patients receive six de-escalating levels of chemotherapy until the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60% graft versus host disease (GVHD) is determined. The target dose level is defined as the level at which 2 of 6 patients develop GVHD, and the next lower dose level has no more than 1 patient experiencing GVHD. Patients are followed every 3 months for the first year, every 6 months for the second year, and yearly thereafter.

PROJECTED ACCRUAL: A total of 18-21 patients will be accrued over 2 years.

Study Timeline

• Study First Submitted: 2000-07-05
• Study Start: 2000-10
• Primary Completion: 2002-06
• Study Completion: 2002-06
• Study First Submitted QC: 2004-03-04
• Study First Posted: 2004-03-05
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Marlene & Stewart Greenebaum Cancer Center, University of Maryland; 🇺🇸 Baltimore, Maryland, United States