T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
This study is ongoing, but not recruiting participants.
Sponsor:
University of Chicago
Information provided by (Responsible Party):
Andrew Artz, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT00683046
First received: May 21, 2008
Last updated: July 8, 2012
Last verified: July 2012
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Purpose
Objectives:
- 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.
- 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.
- 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 | Intervention | Phase |
|---|---|---|
|
Acute Myelogenous Leukemia Lymphoid Leukemia Chronic Myelogenous Leukemia Malignant Lymphoma Hodgkin's Disease Chronic Lymphocytic Leukemia Myeloproliferative Disorder Anemia, Aplastic Myelodysplastic Syndromes |
Drug: Fludarabine Drug: Melphalan Drug: Stem cells Drug: Campath |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
polycythemia vera
MedlinePlus related topics:
Acute Myeloid Leukemia
Anemia
Aplastic Anemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Hodgkin Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Drug Information available for:
Melphalan
Melphalan hydrochloride
Fludarabine
Fludarabine phosphate
Alemtuzumab
U.S. FDA Resources
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Disease-free survival [ Time Frame: annually ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2001 |
| Estimated Study Completion Date: | November 2013 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683046
Locations
| United States, Illinois | |
| The University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
Sponsors and Collaborators
University of Chicago
Investigators
| Principal Investigator: | Andrew Artz, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Andrew Artz, MD, Assistant Professor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00683046 History of Changes |
| Other Study ID Numbers: | 11300A |
| Study First Received: | May 21, 2008 |
| Last Updated: | July 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
Relapsed or refractory acute myelogenous or lymphoid leukemia. Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.Chronic myelogenous leukemia in accelerated phase or blast-crisis. Chronic myelogenous leukemia in chronic phase Chronic myelogenous leukemia in accelerated phase or blast-crisis Recurrent or refractory malignant lymphoma or Hodgkin's disease. |
Chronic lymphocytic leukemia, relapsed or with poor prognostic features. Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features. Severe aplastic anemia after failure of immunosuppressive therapy. Myelodysplastic syndromes (including PNH) Multiple myeloma at high risk for disease recurrence. |
Additional relevant MeSH terms:
|
Anemia Anemia, Aplastic Hodgkin Disease Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Hematologic Neoplasms Hematologic Diseases |
Bone Marrow Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Precancerous Conditions Neoplasms by Site Melphalan Fludarabine Fludarabine monophosphate Alemtuzumab Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 22, 2013