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Bone Marrow Transplant

Treosulfan, Fludarabine + TBI w/Unrelated Cord Blood Transplant (FHCRC-2275)
Transplantation of Unrelated Donor Umbilical Cord Blood in Patients with Hematological Malignancies Using a Treosulfan Based Preparative Regimen
Status Conditions Phase Study ID
Recruiting Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Phase II FHCRC-2275
NCT00796068
Summary

The purpose of this study is to determine whether or not the combination of two chemotherapy drugs, treosulfan and fludarabine, given along with low-dose radiation treatment just prior to cord blood transplant is safe and effective in people with certain forms of leukemia or myelodysplastic syndrome (MDS). This is an experimental treatment for people who are eligible for a transplant but may not be able to tolerate standard high-dose therapy.

Participants in this study will be hospitalized for the transplant at either the University of Washington Medical Center or Seattle Children's. Once discharged from the hospital, follow-up visits will continue at the Seattle Cancer Care Alliance (SCCA) outpatient clinic.

The study treatment, including visits to the SCCA clinic after the transplant, will last about 3 ½ months. Less frequent follow-up visits to the study participant's local physician may be requested for up to 2 years after transplant.

After 2 years, we would like to continue to keep track of the participant's medical condition (by phone) to look at the long-term effects of the study.


Investigator
Colleen Delaney, MD, MSc
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia: Must have < 20% morphologic marrow blasts in an evaluable marrow sample (> 25% of normal cellularity for age) collected less than one month prior to start of conditioning; patients persistently aplastic for greater than one month since completing last chemotherapy are also eligible
  • Myelodysplastic syndrome (MDS): Any 2001 WHO classification subtype; RAEB-2 patients may proceed directly to transplant but may also be considered for induction chemotherapy before transplant; patients with >= 20% morphologic marrow blasts require induction therapy to reduce morphologic marrow blasts below 5% before transplant
  • Chronic myelogenous leukemia: All types, except refractory blast crisis; chronic phase patients must have failed or been intolerant to Gleevec or other tyrosine kinase inhibitors
  • Chronic myelomonocytic leukemia (CMML): Including CMML-1 and CMML-2; previous chemotherapy is not required, but patients with CMML-2 should be considered for pre-transplant cytoreductive therapy
  • Juvenile myelomonocytic leukemia (JMML): Patients are eligible with or without previous chemotherapy, but should be considered for pre-transplant cytoreductive therapy if marrow blasts exceed 15 - 20%
  • Patients < 50 years old must have Karnofsky performance status score (for adults) >= 70; Lansky performance status score (for children) >= 50
  • Adequate cardiac function defined as absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction >= 35%
  • Adequate hepatic function: Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, histology, and the degree of portal hypertension; patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3mg/dL, and symptomatic biliary disease will be excluded
  • Adequate renal function defined as creatinine =< 2.0 mg/dl (adults) or creatinine clearance > 40 ml/min (pediatrics); all adults with a creatinine > 1.2 or a history of renal dysfunction must have estimated creatinine clearance > 40 ml/min
  • If recent mold infection, e.g., Aspergillus, must be cleared by infectious disease to proceed
  • Second hematopoietic cell transplant: Must be >= 3 months after prior myeloablative transplant
  • Patients > 60 must have Karnofsky performance score >= 70 and comorbidity index < 5
Exclusions (conditions that would prevent participation in this study)
  • Patients =< 65 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor or readily available 10/10 matched unrelated donor
  • Pregnancy or breastfeeding
  • Evidence of HIV infection or known HIV positive serology
  • Uncontrolled viral or bacterial infection at the time of study enrollment
  • Active or recent (prior 6 month) invasive fungal infection without ID consult and approval
  • CNS leukemic involvement not clearing with intrathecal chemotherapy and/or cranial radiation prior to initiation of conditioning (day -6)
  • AML in CR1 with favorable prognostic cytogenetics (t8;21, t15;17, inv16) and low risk (IPSS 0) MDS
  • Impaired pulmonary function as evidenced by pO2 < 70 mm Hg and DLCO < 70% of predicted or pO2 < 80 mm Hg and DLCO < 60% of predicted; or receiving supplementary continuous oxygen
Last Updated
October 25, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.