A Myeloablative Conditioning Regimen and Total Body Irradiation Followed by the Transplantation for Patients With Hematological Malignancy

Completed · Phase 2

Conditions studied: Cancer, Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma

In brief

In this study two cord blood collections will be used to increase the number of cord blood cells you will receive on transplant day. We call this a "double unit" cord blood transplant. A previous study suggests double unit cord blood transplant may have a better result. The main purpose of this study is to find out how good a cord blood transplant using two cord blood collections from two different babies is at curing you of your cancer. Double unit cord blood transplants are now being studied as a way to increase the number of cord blood cells given to bigger children and adult patients. Based on studies that have already been done double unit cord blood transplant appears to be safer than if only one cord blood unit is used. However, double unit cord blood transplant is a fairly new form of treatment.

Key facts

Study ID

NCT00597519

Run by

Memorial Sloan Kettering Cancer Center

People needed

28

Starts

2006-03-01

Expected to finish

2015-09-01

Last updated by the study team

2016-02-12

Who can join

Age: 4 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 4 - 50 years
• Patient should not have a related or unrelated volunteer donor that is suitably HLA matched and available in the required time period or be a suitable candidate for an autologous stem cell transplant.
• Patients will have one of the following hematological malignancies: Acute myelogenous leukemia (AML):
• Complete first remission (CR1) at high risk for relapse as defined by:
• known prior diagnosis of myelodysplasia (MDS); or therapy related AML; or White cell count at presentation > 100,000; or Presence of extramedullary leukemia at diagnosis; or Unfavorable FAB type (M0, M5-7); or High-risk cytogenetics (such as those associated with MDS, abnormalities of 5, 7, 8, Philadelphia chromosome, complex karyotype); or High risk molecular markers such as FLT3 mutations; or Requirement for 2 or more inductions to achieve CR1
• Complete second CR (CR2).
• Acute lymphoblastic leukemia (ALL):
• Complete first remission (CR1) at high risk for relapse as defined by:
• White cell count at presentation as follows:
• > 100,000 if < 18 years
• > 50,000 if > 18 years; or
• Presence of extensive extra-medullary disease (excluding CNS disease); or Presence of high-risk cytogenetic abnormality such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23), t(8;14) [excluding B-ALL in pediatric patients]; or
• Failed to achieve complete remission after four weeks of induction therapy Unable to receive required consolidation chemotherapy as would be needed to maintain remission
• Complete second or third remission (CR2 or CR3)
• Acute undifferentiated leukemia (AUL), infant leukemia, or biphenotypic leukemia in CR1, CR2 or CR3. Patients with infant leukemia must be eligible to receive total body irradiation.
• Juvenile Myelomonocytic leukemia (JMML) with < 30% bone marrow blasts.
• Chronic myelogenous leukemia (CML)
• GleevecTM failure in 1st or 2nd chronic phase;
• Gleevec failure in 1st or 2nd accelerated phase.
• Myelodysplastic Syndrome (MDS) with one of the following:
• Low (Score 0) International Prognostic Scoring System (IPSS) score with Life-threatening cytopenia(s); or Red cell or platelet transfusion dependent
• Intermediate (Score 1) or High (Score 2) International Prognostic Scoring System (IPSS) score.
• Patients with bone marrow blasts > 10% should have AML induction therapy with disease response to < 5% blasts and at least partial count recovery.
• Non-Hodgkin's Lymphoma
• Patients with high-grade disease following initial therapy and are not appropriate for further chemotherapy or autologous stem cell transplantation.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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