T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT00683046
Collaborator
(none)
204
1
1
157
1.3

Study Details

Study Description

Brief Summary

Objectives:
  1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

  2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation.

  3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

Study Design

Study Type:
Interventional
Actual Enrollment :
204 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Study Start Date :
Nov 1, 2001
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Drug Intervention

Drug: Fludarabine
Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.

Drug: Melphalan
Melphalan 140 mg/m2 IV on day -2.

Drug: Stem cells
Stem cell infusion on day 0.

Drug: Campath
Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Outcome Measures

Primary Outcome Measures

  1. Median Disease-free Survival [Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years]

    All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 Melphalan 140mg/m2 IV on day -2 Stem cell infusion on day 0 Campath 20mg IV on day -7,-6,-5,-4, and -3

Secondary Outcome Measures

  1. Median Overall Survival [Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years]

    All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 Melphalan 140mg/m2 IV on day -2 Stem cell infusion on day 0 Campath 20mg IV on day -7,-6,-5,-4, and -3

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Zubrod performance status 2 (See Appendix B).

  • Life expectancy is not severely limited by concomitant illness.

  • Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol.

  • Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min .

  • Serum bilirubin 2.0 mg/dl, SGPT <3 x upper limit of normal

  • No evidence of chronic active hepatitis or cirrhosis.

  • HIV-negative

  • Patient is not pregnant

  • Patient or guardian able to sign informed consent.

Exclusion Criteria:
  • N/A

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Chicago Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago

Investigators

  • Principal Investigator: Andrew Artz, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00683046
Other Study ID Numbers:
  • 11300A
First Posted:
May 23, 2008
Last Update Posted:
Nov 22, 2016
Last Verified:
Oct 1, 2016

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title T-cell Depleted Allogeneic Stem Cell Transplantation
Arm/Group Description All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 Melphalan 140mg/m2 IV on day -2 Stem cell infusion on day 0 Campath 20mg IV on day -7,-6,-5,-4, and -3
Period Title: Overall Study
STARTED 204
COMPLETED 204
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title T-cell Depleted Allogeneic Stem Cell Transplantation
Arm/Group Description All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 Melphalan 140mg/m2 IV on day -2 Stem cell infusion on day 0 Campath 20mg IV on day -7,-6,-5,-4, and -3
Overall Participants 204
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
51.0
(12.0)
Sex: Female, Male (Count of Participants)
Female
93
45.6%
Male
111
54.4%

Outcome Measures

1. Primary Outcome
Title Median Disease-free Survival
Description All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 Melphalan 140mg/m2 IV on day -2 Stem cell infusion on day 0 Campath 20mg IV on day -7,-6,-5,-4, and -3
Time Frame Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title T-cell Depleted Allogeneic Stem Cell Transplantation
Arm/Group Description All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 Melphalan 140mg/m2 IV on day -2 Stem cell infusion on day 0 Campath 20mg IV on day -7,-6,-5,-4, and -3
Measure Participants 204
Median (95% Confidence Interval) [Days]
333
2. Secondary Outcome
Title Median Overall Survival
Description All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 Melphalan 140mg/m2 IV on day -2 Stem cell infusion on day 0 Campath 20mg IV on day -7,-6,-5,-4, and -3
Time Frame Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title T-cell Depleted Allogeneic Stem Cell Transplantation
Arm/Group Description All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 Melphalan 140mg/m2 IV on day -2 Stem cell infusion on day 0 Campath 20mg IV on day -7,-6,-5,-4, and -3
Measure Participants 204
Median (95% Confidence Interval) [Days]
547

Adverse Events

Time Frame 180 days
Adverse Event Reporting Description
Arm/Group Title T-cell Depleted Allogeneic Stem Cell Transplantation
Arm/Group Description All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 Melphalan 140mg/m2 IV on day -2 Stem cell infusion on day 0 Campath 20mg IV on day -7,-6,-5,-4, and -3
All Cause Mortality
T-cell Depleted Allogeneic Stem Cell Transplantation
Affected / at Risk (%) # Events
Total / (NaN)
Serious Adverse Events
T-cell Depleted Allogeneic Stem Cell Transplantation
Affected / at Risk (%) # Events
Total 69/204 (33.8%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders, other 2/204 (1%)
Bone marrow hypocellular 1/204 (0.5%)
Febrile neutropenia 3/204 (1.5%)
Thrombotic thrombocytopenic purpura 4/204 (2%)
Cardiac disorders
Atrial fibrillation 2/204 (1%)
Endocarditis infective 1/204 (0.5%)
Heart Failure 2/204 (1%)
Supraventricular tachycardia 1/204 (0.5%)
Eye disorders
Retinal detachment 1/204 (0.5%)
Gastrointestinal disorders
Abdominal pain 1/204 (0.5%)
Colitis 2/204 (1%)
Diarrhea 3/204 (1.5%)
General disorders
Fever 1/204 (0.5%)
Syncope 1/204 (0.5%)
Hepatobiliary disorders
Hepatic failure 3/204 (1.5%)
Infections and infestations
Abdomial infection 2/204 (1%)
Bladder infection 1/204 (0.5%)
Bone infection 1/204 (0.5%)
Catheter related infection 5/204 (2.5%)
Infection and infestations - other, specify 23/204 (11.3%)
Pharyngitis 1/204 (0.5%)
Sepsis 11/204 (5.4%)
Skin infection 1/204 (0.5%)
Injury, poisoning and procedural complications
Post operative hemorrhage 1/204 (0.5%)
Metabolism and nutrition disorders
Hyperkalemia 1/204 (0.5%)
Hypoglycemia 1/204 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy 1/204 (0.5%)
Nervous system disorders
Cognitive disturbance 1/204 (0.5%)
Encephalopathy 1/204 (0.5%)
Psychiatric disorders
Confusion 2/204 (1%)
Renal and urinary disorders
Acute kidney injury 1/204 (0.5%)
Chronic kidney disease 1/204 (0.5%)
Reproductive system and breast disorders
Vaginal hemorrhage 1/204 (0.5%)
Respiratory, thoracic and mediastinal disorders
Adult Respiratory distress syndrome 8/204 (3.9%)
Bronchopulmonary hemorrhage 1/204 (0.5%)
Dyspnea 2/204 (1%)
Pneumonitis 3/204 (1.5%)
Respiratory failure 2/204 (1%)
Vascular disorders
Thromboembolic event 3/204 (1.5%)
Other (Not Including Serious) Adverse Events
T-cell Depleted Allogeneic Stem Cell Transplantation
Affected / at Risk (%) # Events
Total 0/204 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Andrew Artz
Organization University of Chicago Medicine
Phone 773-834-8980
Email aartz@medicine.bsd.uchicago.edu
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00683046
Other Study ID Numbers:
  • 11300A
First Posted:
May 23, 2008
Last Update Posted:
Nov 22, 2016
Last Verified:
Oct 1, 2016