NCT00409695

Brief Summary

Primary Objective:

  • To determine the response and toxicity rate at day 56 of two different dose levels of thymoglobulin (ATG) \[anti-thymocyte globulin (rabbit)\] as a treatment of steroid-refractory acute graft versus host disease (aGVHD). Secondary Objectives:
  • To evaluate the response rate at day 28.
  • To evaluate the overall survival and non-relapse mortality at 6 months.
  • To determine the toxicity profile of thymoglobulin when used for the treatment of steroid-refractory aGVHD in each of two dose schedules.
  • To characterize the pharmacokinetic profile of thymoglobulin in each of two dose schedules.
  • To analyze biomarkers of cellular drug effect by quantifying T-cell apoptosis in aims of finding the minimal effective dose.
  • To determine immune-reconstitution after administration of thymoglobulin to patients with steroid-refractory aGVHD for each dose schedule.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 23, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

December 7, 2006

Last Update Submit

January 19, 2012

Conditions

Graft vs Host Disease

Keywords

Acute Graft versus Host DiseaseaGVHDBlood And Marrow TransplantationThymoglobulinATG

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    Response assessed at day 56, and a complete response or partial response considered a success. A toxic event defined as a life threatening infection, any death due to infection, or any death considered to be directly related to the administration of ATG.

    Day 56

Study Arms (2)

High Dose Thymoglobulin (ATG)

EXPERIMENTAL

High Dose Thymoglobulin (ATG): 1.25mg/kg by vein every other day for 3 doses (total dose = 3.75mg/kg)

Drug: High Dose Thymoglobulin (ATG)

Low Dose Thymoglobulin (ATG)

EXPERIMENTAL

Low Dose Thymoglobulin (ATG): 2.5 mg /kg by vein every other day for 3 doses (total dose = 7.5 mg/ kg).

Drug: Low Dose Thymoglobulin (ATG)

Interventions

Low Dose Thymoglobulin (ATG)DRUG

2.5 mg /kg by vein every other day for 3 doses (total dose = 7.5 mg/ kg).

Also known as: ATG, Antithymocyte Globulin
Low Dose Thymoglobulin (ATG)
High Dose Thymoglobulin (ATG)DRUG

1.25mg/kg by vein every other day for 3 doses (total dose = 3.75mg/kg)

Also known as: ATG, Antithymocyte Globulin
High Dose Thymoglobulin (ATG)

Eligibility Criteria

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

You may qualify if:

  • Patients who underwent their first allogeneic transplant for any malignancy and with any cell (bone marrow, peripheral stem cell, cord blood) or donor (matched or mismatched related or unrelated) source.
  • Biopsy-proven, grade II-IV aGVHD following allogeneic hematopoietic stem cell transplantation (HSCT) of any source (bone marrow, peripheral blood or cord blood stem cells). Enrollment may be started prior to results of biopsy in cases of high clinical suspicion for aGVHD.
  • Early steroid-refractory aGVHD. This is defined as any NR or PD after a minimum of 3 days and not more than 1 week of 1 mg/kg/day of methylprednisolone.
  • Ability to sign informed consent.
  • Ability to return for clinical follow-up as specified in the protocol.
  • Inability to taper as defined by patients on \< or = 1 mg/kg/day of methylprednisolone but unable to further taper without resultant increase of acute GVHD stage.
  • Patients with a reflare of a GVHD defined as worsening of 1 stage of acute GVHD in a patient who initially responded.

You may not qualify if:

  • Relapsed malignancy.
  • Acute GVHD as a result of a second or subsequent transplant or donor lymphocyte infusion (DLI).
  • Active, uncontrolled infection.
  • Patients who have received any second-line of immunosuppressive treatment for GVHD beyond corticosteroids and calcineurin inhibitors. Topical steroids, oral budesonide and extracorporeal photochemotherapy started at the time of steroids are allowed.
  • Life-threatening infusion reaction or hypersensitivity to any formulation of ATG in the past.
  • Patients who are pregnant or are breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

thymoglobulinAntilymphocyte Serum

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex Mixtures

Study Officials

  • Amin M. Alousi, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 11, 2006

Study Start

December 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 23, 2012

Record last verified: 2012-01

Locations

US(1)