In-Vivo Activated T-Cell Depletion to Prevent GVHD

• Sponsor: Indiana University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00594308
• Collaborator: (none)
• Enrollment: 10
• Location: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease.

This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Myelodysplasia; Lymphoma, Non-Hodgkin's; Mantle-Cell Lymphoma; Hodgkin's Disease; Multiple Myeloma; Myelofibrosis	Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Cyclosporine; Drug: Mycophenolate mofetil; Drug: Basiliximab	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: In-Vivo Activated T-Cell Depletion to Prevent GVHD
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Oct 1, 2008

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Acute Grade II-IV GVHD [until 30 days after stem cell transplant]

   Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.

Secondary Outcome Measures

1. Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's). [until 30 days after stem cell transplant]

2. Number of Days for Absolute Neutrophil Count to Recover [From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)]

   Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days).

3. Time to Resolution of Cytopenias: Platelet Transfusion Independence [From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)]

   Average number of days per patient for resolution of cytopenias.

4. Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria. [up to 2 years after stem cell transplant]

   Number of patients who died due to transplant related toxicities

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acute myelogenous leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Chronic lymphocytic leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Mantle cell, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis with disease-specific eligibility requirements as outlined in the protocol

• Donor Requirement: Must have a fully HLA-matched (10 of 10) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis.

Exclusion Criteria:

• Active CNS disease (the presence of leukemic blasts in the CSF)

• Pregnancy or breast-feeding

• SGOT >3x upper limit of normal

• Creatinine >2 or creatinine clearance <50cc/hr.

• Fractional shortening by echocardiogram not within normal limits per institution

• Pulmonary function: DLCO less that 50% of normal predicted, corrected for anemia

• Prior allogeneic transplant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana Universtiy Simon Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

• Principal Investigator: Robert Nelson, MD, Indiana Universtiy School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Indiana University
• ClinicalTrials.gov Identifier: NCT00594308
• Other Study ID Numbers: 0705-20 IUCRO-0196
• First Posted: Jan 15, 2008
• Last Update Posted: Oct 6, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Lymphoma, Mantle-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Hodgkin Disease; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Cyclosporine; Mycophenolic Acid; Cyclophosphamide; Fludarabine; Cyclosporins; Basiliximab

Study Results

Participant Flow

Arm/Group Title	Basiliximab 20 mg
Arm/Group Description	All patients that received Basiliximab 20 mg monoclonal therapy
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Basiliximab 20 mg
Arm/Group Description	All patients that received Basiliximab 20 mg monoclonal therapy
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.80 (11.29)
Sex: Female, Male (Count of Participants)
Female	7 70%
Male	3 30%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Acute Grade II-IV GVHD
Description	Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.
Time Frame	until 30 days after stem cell transplant

Outcome Measure Data

Analysis Population Description

All patient that received study drug

Arm/Group Title	Basiliximab 20 mg
Arm/Group Description	All patients that received Basiliximab 20 mg monoclonal therapy
Measure Participants	10
Number [participants]	10 100%

2. Secondary Outcome

Title	Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).
Time Frame	until 30 days after stem cell transplant

Outcome Measure Data

Analysis Population Description

ITT population. All patient that received study drug

Arm/Group Title	Basiliximab 20 mg
Arm/Group Description	All patients that received Basiliximab 20 mg monoclonal therapy
Measure Participants	10
Number [participants]	10 100%

3. Secondary Outcome

Title	Number of Days for Absolute Neutrophil Count to Recover
Description	Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days).
Time Frame	From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)

Outcome Measure Data

Analysis Population Description

ITT: All patient that received study drug

Arm/Group Title	Basiliximab 20 mg
Arm/Group Description	All patients that received Basiliximab 20 mg monoclonal therapy
Measure Participants	10
Mean (Standard Deviation) [days per patient]	14.00 (3.80)

4. Secondary Outcome

Title	Time to Resolution of Cytopenias: Platelet Transfusion Independence
Description	Average number of days per patient for resolution of cytopenias.
Time Frame	From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)

Outcome Measure Data

Analysis Population Description

IIT: All patients that received study drug.

Arm/Group Title	Basiliximab 20 mg
Arm/Group Description	All patients that received Basiliximab 20 mg monoclonal therapy
Measure Participants	10
Mean (Standard Deviation) [days per patient]	15.33 (3.54)

5. Secondary Outcome

Title	Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.
Description	Number of patients who died due to transplant related toxicities
Time Frame	up to 2 years after stem cell transplant

Outcome Measure Data

Analysis Population Description

Intent To Treat: All patients that received study drug

Arm/Group Title	Basiliximab 20 mg
Arm/Group Description	All patients that received Basiliximab 20 mg monoclonal therapy
Measure Participants	10
Number [participants]	10 100%

Adverse Events

Arm/Group Title	Basiliximab 20 mg
Arm/Group Description	All patients that received Basiliximab 20 mg monoclonal therapy
All Cause Mortality
	Basiliximab 20 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Basiliximab 20 mg
	Affected / at Risk (%)	# Events
Total	4/10 (40%)
Immune system disorders
GvHD	4/10 (40%)	4
Other (Not Including Serious) Adverse Events
	Basiliximab 20 mg
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

Four patients experienced grade 3-4 GVHD and this study was stopped.

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.