T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
This trial is active, not recruiting.
|Conditions||acute myelogenous leukemia, lymphoid leukemia, chronic myelogenous leukemia, malignant lymphoma, hodgkin's disease, chronic lymphocytic leukemia, myeloproliferative disorder, anemia, aplastic, myelodysplastic syndromes|
|Treatments||fludarabine, melphalan, stem cells, campath|
|Sponsor||University of Chicago|
|Start date||November 2001|
|End date||December 2013|
|Trial size||204 participants|
|Trial identifier||NCT00683046, 11300A|
1. 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.
2. 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.
3. 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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Median Disease-free Survival
time frame: 10 years
Median Overall Survival
time frame: 10 years
Male or female participants of any age.
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
|Official title||T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies|
|Principal investigator||Andrew Artz, MD|
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