NCT00586547

Brief Summary

This study is designed to determine the number of donor lymphocytes that can be given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin, and will result in a rate of Grade III/IV GVHD of \< / = 25%, to analyze immune reconstitution in these patients, and to measure their overall and disease free survival, at 100 days and at 1 year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_1 leukemia

Geographic Reach
1 country

2 active sites

Status
completed

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

July 1, 2000

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

8.2 years

First QC Date

December 21, 2007

Last Update Submit

January 16, 2020

Conditions

LeukemiaCancer

Keywords

HaploidenticalStem Cell TransplantGraft-Versus-Host disease

Outcome Measures

Primary Outcomes (1)

  • Determining the number of donor lymphocytes given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin.

    100

Secondary Outcomes (1)

  • To measure their overall and disease free survival.

    1 year

Study Arms (1)

Treatment

EXPERIMENTAL

After patients have completed preparation to receive cells, they will be treated at one of five dose levels.

Biological: T-Cell Infusion Dose Level -1Biological: T-Cell Infusion Dose Level 1Biological: T-Cell Infusion Dose Level 2Biological: T-Cell Infusion Dose Level 3Biological: T-Cell Infusion- Dose Level 4

Interventions

T-Cell Infusion Dose Level 1BIOLOGICAL

(1 x 10\^4 T cells/Kg)

Treatment
T-Cell Infusion Dose Level 2BIOLOGICAL

(1 x 10\^5 T cells/Kg)

Treatment
T-Cell Infusion Dose Level 3BIOLOGICAL

(1 x 10\^6 T cells/Kg)

Treatment
T-Cell Infusion- Dose Level 4BIOLOGICAL

(5 x 10\^6 T cells/Kg)

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ALL or high grade NHL that is Stage III or IV and has relapsed or is considered to be primary refractory disease.
  • Myelodysplastic syndrome.
  • AML after first relapse or with primary refractory disease.
  • CML hemophagocytic lymphohistiocytosis (HLH)
  • Familial hemophagocytic lymphohistiocytosis (FLH)
  • Viral-associated hemophagocytic syndrome (VAHS)
  • X-linked lymphoproliferative disease (XLP)
  • Patients with Severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T- or NK-cell malignancy
  • Lack of suitable conventional donor (i.e. 5/6 or 6/6 related or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor.
  • Donor cells should be collected and frozen before conditioning starts.

You may not qualify if:

  • Patients with a life expectancy (\< or = to 6 weeks) limited by diseases other than leukemia.
  • Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e. shortening fraction \< 25%)
  • Patients with severe renal disease (i.e. creatinine clearance less than 40cc/1.73m2)
  • Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of predicted)
  • Patients with severe hepatic disease (direct bilirubin greater than 3ug/dl or SGPT greater than 500ug/dl)
  • Patients with severe personality disorder or mental illness that would preclude compliance with the study
  • Patients with a severe infection that on evaluation by the Principal Investigator precluded ablative chemotherapy or successful transplantation
  • Patients with documented HIV positivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Methodist Hospital

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

LeukemiaNeoplasmsGraft vs Host Disease

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesImmune System Diseases

Study Officials

  • Malcolm Brenner, MB, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dist Serv Prof, Center for Gene Therapy

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

July 1, 2000

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 21, 2020

Record last verified: 2020-01

Locations

US(2)