Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marr… (NCT00027547) | Clinical Trial Compass
CompletedPhase 1/2
Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
United States, GermanyStarted 2001-07
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and donor white blood cells may prevent this from happening.
PURPOSE: Phase I/II trial to determine the effectiveness of combination chemotherapy and total-body irradiation followed by peripheral stem cell transplantation in treating patients who have acute lymphoblastic leukemia.
Who can participate
Age range75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Diagnosis of acute lymphoblastic leukemia (ALL)
* Adult patients must meet 1 of the following criteria:
* Age 50 to 75 with high-risk ALL in complete remission (CR) (less than 5% blasts by morphology on bone marrow aspirate and absence of peripheral blasts) or ALL in second CR (CR2) or greater
* Age 18 to 50 with high-risk ALL in first CR (CR1) and either ineligible for conventional allogeneic transplantation (based on general medical condition) or refused conventional transplantation
* High-risk adult ALL in CR1 includes patients meeting 1 or more of the following criteria:
* Age 30 and over
* Non-T-cell phenotype
* Cytogenetic abnormalities including t(9;22), t(4;11), trisomy 8, or monosomy 7
* Failure to achieve CR after 4 weeks of induction chemotherapy
* Age 18 to 50 with ALL in CR2 or greater and ineligible for conventional allogeneic transplantation based on general medical condition
* Age 18 to 50 with high-risk ALL in CR2 or greater and refused conventional allogeneic transplantation
* Pediatric patients must meet 1 of the following criteria:
* Under age 18 with high-risk ALL in CR1 and ineligible for conventional allogeneic transplantation based on general medical condition
* High-risk pediatric ALL in CR1 includes patients meeting 1 or more of the following criteria:
* Cytogenetic abnormalities
* t(9;22) with WBC at least 25,000/mm3 at diagnosis
* t(4;11) in patients …