Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)

Trial ID or NCT#

NCT00185523

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of the study is to evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stem cells from HLA matched sibling donors.

Official Title

Allogeneic Peripheral Blood Stem Cell Transplantation for Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First or Second Remission or Chronic Myelogenous Leukemia in First and Second Chronic Phase or Accelerated Phase

Eligibility Criteria

Ages Eligible for Study: 4 Weeks to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Any patient with one of the following hematologic malignancies in whom an allogeneic stem cell transplant is warranted: Specific disease categories include:
  2. 1. acute myelogenous leukemia, 1st or 2nd remission2. acute lymphoblastic leukemia, 1st or 2nd remission3. chronic myelogenous leukemia, 1st or 2nd CP, accelerated phase 2. Patient age \> 1 month and \< 55 yo 3. Patients must have a genotypically HLA identical sibling 4. Patient must have adequate function as follows:
    1. a. total bilirubin \<2.5 and SGOT/SGPT \<2x normal b. adequate renal function as defined by creatinine \< 1.5 or a 24 hr creatinine clearance \>50 cc/min as determined by the Cockroft-Gault formula (to be done if serum creatinine \> 1.5) c. DLCO \> 60% predicted d. radionuclide cardiac scan with ejection fraction \>45% 5. Patient must be competent to give consent.
      1. Inclusion criteria (Donor):
  3. 1. HLA identical family member2. Donor or guardian must be competent to give consent3. Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter
Exclusion Criteria:
  1. 3.2 Exclusion Criteria (Patient):
  2. 1. Evidence of active infection or active hepatitis2. Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+3. Previous allogeneic stem cell/bone marrow transplant4. Pregnant or lactating patients
  3. 4 Exclusion criteria (Donor):
  4. 1. Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC harvest2. Donors who are HIV+ or hepatitis B antigen +3. History of allergic reaction to G-CSF4. Female donors must be post-menopausal or have a negative pregnancy test
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Investigator(s)

Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Robert Negrin
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Laura Johnston
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist, Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy), Emerita
Judith Shizuru
Judith Shizuru
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist, Hematologist-Oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

BMT Referrals
6507230822

View on ClinicalTrials.gov