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Combination Chemotherapy Followed By Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Severe Aplastic Anemia

NCT00054236 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-07-27

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by umbilical cord blood transplantation in treating patients who have hematologic cancer or severe aplastic anemia.

Conditions

Interventions

BIOLOGICAL

anti-thymocyte globulin

anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1

BIOLOGICAL

filgrastim

Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover.

DRUG

cyclophosphamide

cyclophosphamide IV over 2 hours on days -3 to -2

DRUG

fludarabine phosphate

fludarabine IV over 30 minutes on days -8 to -4

PROCEDURE

umbilical cord blood transplantation

Patients undergo multiple unit umbilical cord blood transplantation on days 0-1.

DRUG

methylprednisolone

Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Brenda Cooper, MD · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2011-03-31
Completion
2011-03-31

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 NCT00054236 on ClinicalTrials.gov