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Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplant in Treating Patients With Leukemia or Lymphoma

NCT00006252 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2016-07-18

No results posted yet for this study

Summary

RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer 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.

PURPOSE: This phase II trial is studying how well fludarabine and cyclophosphamide followed by peripheral stem cell transplant works in treating patients with leukemia or lymphoma.

Conditions

Interventions

DRUG

fludarabine phosphate

30 mg/sq m/day IV infusion for 5 days (Days -7 thru -3)

DRUG

Cyclophosphamide

1 g/sq m/day IV infusion x 3 days (Days -5 thru -3)

BIOLOGICAL

PBSC

2-8,000,000/kg CD34+ cells via infusion on Day 0

DRUG

G-CSF

5 ug/kg/day subQ injection until ANC \> 1000/uL for 3 days beginning Day 5

BIOLOGICAL

Donor lymphocytes

10,000,000 CD3+ cells/kg via infusion

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer and Leukemia Group B

    lead NETWORK

Principal Investigators

  • Thomas Shea, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2007-01-31
Completion
2011-10-31

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 NCT00006252 on ClinicalTrials.gov