T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Study Details
Study Description
Brief Summary
Objectives:
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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.
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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.
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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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
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
- 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
- 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
Inclusion Criteria:
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Zubrod performance status 2 (See Appendix B).
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Life expectancy is not severely limited by concomitant illness.
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Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol.
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Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min .
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Serum bilirubin 2.0 mg/dl, SGPT <3 x upper limit of normal
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No evidence of chronic active hepatitis or cirrhosis.
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HIV-negative
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Patient is not pregnant
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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.- 11300A
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
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
|
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
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 |
aartz@medicine.bsd.uchicago.edu |
- 11300A