Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin's Disease Non Hodgkin's Lymphoma Myeloma Leukemia Myelodysplasia |
Drug: Non-myeloablative Stem Cell Transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplantation |
- 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 ] [ Designated as safety issue: Yes ]
- Evaluate immune recovery following this reduced intensity allogeneic immunotherapy. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Develop an in vitro assay to allow patient individualized targeted dosing for busulfan [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 189 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohorts A and B
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. |
Drug: Non-myeloablative Stem Cell Transplantation
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 infused over 3 hours. For the Group B cohort, the prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Patient evaluations will occur 2 times per week by physical exam for toxicity through day 45.
Other Name: Allogeneic Stem Cell Transplant
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Jennifer Loftis, RN, BSN, OCN | 919-668-1939 | lofti002@mc.duke.edu |
| Contact: Donna Adams, RN, BSN, OCN | 919-668-4716 | adams068@mc.duke.edu |
| United States, North Carolina | |
| Duke University Health System | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: David Rizzieri, MD 919-668-1014 rizzi003@mc.duke.edu | |
| Contact: Nelson Chao, MD 919-668-1011 chao0002@mc.duke.edu | |
| Principal Investigator: David Rizzieri, MD | |
| Principal Investigator: | David Rizzieri, MD | Duke University Health System |
More Information
No publications provided
| Responsible Party: | David Rizzieri, Associate Professor of Medicine, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00597714 History of Changes |
| Other Study ID Numbers: | Pro00003567 |
| Study First Received: | January 14, 2008 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Duke University:
|
Stem Cell Transplantation, Non-myeloablative |
Additional relevant MeSH terms:
|
Hodgkin Disease Leukemia Lymphoma Lymphoma, Non-Hodgkin Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
ClinicalTrials.gov processed this record on June 13, 2013