NCT00048399

Brief Summary

To assess the safety, feasibility, and rate of donor engraftment for patients with primary or secondary engraftment failure after treatment with fludarabine and CAMPATH 1H used as a preparative regimen for HLA-identical sibling blood stem cell transplantation (SCT). To assess the safety, feasibility, and rate of donor engraftment for patients with primary or secondary engraftment failure after treatment with fludarabine and CAMPATH 1H as a preparative regimen for matched unrelated or single antigen mismatched family donor marrow transplantation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2000

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2002

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2003

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.9 years

First QC Date

October 30, 2002

Last Update Submit

January 15, 2020

Conditions

Graft Failure

Interventions

FludarabineDRUG
CAMPATH 1HDRUG
FK506DRUG
Stem Cell TransplantationPROCEDURE

Eligibility Criteria

AgeUp to 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of engraftment failure either primary or secondary, following allogeneic transplantation. Graft failure is defined as absolute neutrophil count \< 500/mm3 and/or platelet count \< 20,000/mm3. Primary graft failure is defined as failure to maintain absolute neutrophil count \> / = 500/mm3 for 3 consecutive days following allogeneic transplantation. Secondary graft failure is defined as failure to sustain an absolute neutrophil count \> / = 500/mm3 after attainment of primary engraftment or failure to sustain platelet count \> / = 20,000/mm3 despite neutrophil engraftment. For SCID patients, graft failure is defined as failure to recover \> / = 500/mm3 T-cells and/or failure to generate satisfactory response to in vitro mitogen stimulation. For patients with genetic diseases, engraftment failure is defined as donor chimerism insufficient to correct or overcome the genetic or metabolic deficiency.
  • Available Healthy Donor without any contraindications for donation (5/6 or 6/6 related donor or 5/6 or 6/6 unrelated donor (molecular typing for DRB1)
  • Age between birth and 65
  • For women of childbearing potential, negative pregnancy test

You may not qualify if:

  • Pregnant and lactating women or women unwilling to use contraception.
  • Uncontrolled intercurrent infection
  • Refractory AML or ALL
  • Untreated Blast Crisis for CML
  • Uncontrolled High-grade lymphoproliferative disease/lymphoma
  • Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)
  • Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)
  • Hemodialysis dependent
  • Active Hepatitis or cirrhosis with total bilirubin, SGOT, or SGPT greater than 3 x normal.
  • Concurrent solid organ malignancy not in remission, except for Stage 0 or A prostate cancer.
  • Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months)
  • Active CNS disease from hematological disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

fludarabineAlemtuzumabTacrolimusStem Cell Transplantation

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMacrolidesLactonesOrganic ChemicalsCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Robert K. Krance, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 30, 2002

First Posted

November 1, 2002

Study Start

December 1, 2000

Primary Completion

October 31, 2003

Study Completion

October 31, 2003

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(2)