Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Durham, North Carolina 27710


Purpose:

The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease and improved disease free and overall survival compared with historical expectations. Specifically, the objectives are to estimate toxicity, disease free, progression free, event free, and overall survival rates in patients treated with alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation; evaluate immune recovery following this reduced intensity allogeneic immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing.


Study summary:

The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease and improved disease free and overall survival compared with historical expectations. Specifically, the objectives are to estimate toxicity, disease free, progression free, event free and overall survival rates in patients treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation; evaluate immune recovery following this reduced intensity allogeneic immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing. The study population is HIV negative, adult patients who are not pregnant but have confirmed diagnosis of disease; must have CALGB PS 0, 1, or 2; must have a 3-6/6 HLA-matched related donor or 8/8 (A, B, C, DRB1, DQ are the primary determinants) or better HLA-matched unrelated donor who is evaluated and deemed able to provide PBPCs and/or marrow by the transplant team. The target population of patients is those with a high chance of progressive lymphoid or myelomatous diseases, progressive myeloid diseases, marrow failure syndromes or myeloproliferative disorders.


Criteria:

Inclusion Criteria: - Patients must have their diagnosis confirmed at the transplant center. - Performance status must be CALGB PS 0, 1, or 2. - Patients must have a 3-6/6 HLA-matched related donor or 8/8 or better allele level match MUD matched unrelated donor (at A,B, C, DRB1, DQ). - HIV negative. - Women of child bearing potential must have a negative pregnancy serum beta-HCG test within 1 week of starting therapy. - Patients > or equal to 18 years of age are eligible. - Patients must have a MUGA and/or ECHO or cardiac MR and PFTs with DLCO performed before transplant. - Specific patient populations: - Group A) Patients with a high chance of progressive lymphoid or myelomatous diseases. - Group B) Patients with a high chance of progressive myeloid diseases, marrow failure syndromes or myeloproliferative disorders Exclusion Criteria: - Pregnant or lactating women. - Patients with other major medical or psychiatric illnesses which the treating physician feels could seriously compromise tolerance to this protocol. - Patients with uncontrolled, progressive infections. - Patients who are good candidates for long term disease control with standard chemotherapy or radiation or high dose therapy and autologous support. - Patients with active CNS disease.


Study is Available At:


Original ID:

Pro00003567


NCT ID:

NCT00597714


Secondary ID:


Study Acronym:


Brief Title:

Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant


Official Title:

Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplantation


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

189


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:David Rizzieri, MD
Principal Investigator
Duke University Health System

Study Dates

Start Date:February 2008
Completion Date:January 2017
Completion Type:Anticipated
Primary Completion Date:June 2016
Primary Completion Type:Anticipated
Verification Date:September 2013
Last Changed Date:September 6, 2013
First Received Date:January 14, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Develop an in vitro assay to allow patient individualized targeted dosing for busulfan
Time Frame:36 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Evaluate immune recovery following this reduced intensity allogeneic immunotherapy.
Time Frame:36 months
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Estimate toxicity, disease free, progression free and overall survival rates in patients treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation
Time Frame:36 months
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Non-myeloablative Stem Cell Transplantation
Description:Donor will receive G-CSF 8 mcg/kg/d subcutaneously bid for 4 days, until pheresis is completed or until WBC is > 100,000. Recipients in both cohorts will be premedicated with Benadryl 50 mg IV or PO, and acetaminophen 650 mg orally (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline i
Arm Name:Cohorts A and B
Other Name:Allogeneic Stem Cell Transplant

Study Arms

Study Arm Type:Experimental
Arm Name:Cohorts A and B
Description:Group A: Patients with a high chance of progressive lymphoid or myelomatous disease. Group B: Patients with a high chance of progressive myeloid diseases, marrow failure syndromes or myeloproliferative disorders.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:David Rizzieri

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.