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Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies

NCT00741455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-11-23

Study results available
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Summary

The purpose of this study is to determine disease-free survival, overall survival, time to progression, regimen-related toxicity and/or treatment-related mortality in patients with hematologic malignancies treated with non-myeloablative chemotherapy followed by allogeneic stem cell transplant.

Conditions

Interventions

PROCEDURE

Stem Cell Transplant

Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.

DRUG

G-CSF

10 mcg/kg/day on days 5, 6, and 7

DRUG

Fludarabine

25 mg/m2/d IV over 30 minutes on days -6 to -2

DRUG

cyclophosphamide

1 g/m2/d IV on days -3 and -2

DRUG

Cyclosporine

used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml

DRUG

Methotrexate

used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • John M Hill, MD · Dartmouth-Hitchcock Medical Center

  • Kenneth R Meehan, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2020-05-01
Completion
2020-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00741455 on ClinicalTrials.gov