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A Reduced Intensity Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Leukemia, Myelodysplastic Syndrome, Non-Hodgkins Lymphoma, Chronic Myelogenous Leukemia

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Trial Information

A Reduced Intensity Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.


Inclusion Criteria:



- At least one cycle of induction or re-induction chemotherapy or lymphoma chemotherapy
or azacitidine or decitabine or tyrosine kinase inhibitor.

- Patients aged 18-70 years at initial referral with no available and suitably matched
related or unrelated donor.

- Acute myelogenous leukemia (AML):

- Complete first remission (CR1) at high risk for relapse as defined by:

- Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder;

- Therapy related AML;

- White cell count at presentation > 100,000;

- Presence of extramedullary leukemia at diagnosis;

- Any unfavorable sub type by FAB or WHO classification;

- High-risk cytogenetics (eg those associated with MDS, abnormalities of 5, 7, 8,
Philadelphia chromosome, complex karyotype)or high risk molecular abnormalities;

- Requirement for 2 or more inductions to achieve CR1.

- Any patient with newly diagnosed AML with intermediate risk cytogenetics.

- Any patient unable to tolerate consolidation chemotherapy as would have been deemed
appropriate by the treating physician.

- Complete second remission (CR2).

- Other acute leukemias that are ambiguous lineage or of other types eg blastic
plasmacytoid dendritic cell neoplasm in CR1 or CR2

- Acute lymphoblastic leukemia (ALL):

- lymphoblastic leukemia (ALL):

- Complete first remission (CR1) at high risk for relapse as defined by:

- White cell count at presentation > 30,000 for B-cell lineage and >100,000 for Tcell
lineage;

- Presence of a high-risk cytogenetic abnormality such as t(9;22), t(1;19), t(4;11) or
other MLL rearrangements (11q23)or other high-risk molecular abnormality;

- Failure to achieve complete remission after four weeks of induction therapy;

- Any patient with newly diagnosed ALL > or = to 50 years-old;

- Any patient unable to tolerate consolidation and/or maintenance chemotherapy as would
have been deemed appropriate by the treating physician.

- Complete second remission (CR2).

- Myelodysplastic Syndrome (MDS):

- Intermediate-1 International Prognostic Scoring System (IPSS) score with poor risk
cytogenetics as defined by IPSS.

- Intermediate- 2 or High International Prognostic Scoring System (IPSS) score.

- MDS/ myeloproliferative disorder overlap syndromes.

- Any score with life threatening cytopenia(s), including red cell or platelet
transfusion dependence.

- Receipt of at least one cycle of cytotoxic chemotherapy, azacitidine or decitabine.

- MDS patients must have < or = to 5% bone marrow myeloblasts and ANC > or = to 0.5
(growth factor supported if necessary) at transplant work-up.

- Chronic myelogenous leukemia (CML) patients who have failed or are intolerant of
tyrosine kinase inhibitors.

- Any Non-Hodgkins lymphoma (including chronic lymphocytic leukemia) at high-risk of
relapse not suitable for either high dose myeloablative conditioning or
non-myeloablative conditioning

- Eligible patients with DLC NHL will:

have relapsed disease following initial therapy but failed to mobilize or had bone marrow
involvement and therefore are not suitable for an autologous transplant OR

- have failed an autologous transplant and be in CR after salvage chemotherapy.

- Eligible patients with transformed indolent NHL/CLL will:

have CR/PR of the large cell component of their disease after either salvage chemotherapy
or an autologous transplant.

- Eligible patients with mantle cell NHL will:

be high-risk as such as p53 positivity and be in 1st CR/PR after initial therapy OR have
relapsed disease following initial therapy and be in 2nd or 3rd CR/PR after salvage
chemotherapy.

- Eligible patients with indolent B cell NHL (such as, but not limited to, follicular,
small cell or marginal zone NHL) or CLL will have 2nd or subsequent progression
(pre-allograft cytoreduction necessary but CR/PR not required).

- Timing of UCBT:

- Admission for UCBT must be within an acceptable time period after the pre-allograft
chemotherapy. This will be defined as within 100 days of the start day of the last
cycle of chemotherapy (or decitabine or azacitidine) or other disease active agent).

- Organ Function and Performance Status Criteria:

- Karnofsky score > or = to 70 %.

- calculated creatinine clearance > or = to 60 ml/min

- bilirubin < than or = to 1.5 mg/dL, ALT < than or = to 3 x upper limit of normal
unless benign congenital hyperbilirubinemia,

- pulmonary function (spirometry and corrected DLCO) > or = to 50% normal.

- left ventricular ejection fraction > or = to 50%.

- albumin > or = to 3.0.

- Graft Criteria:

- 2 UCB units selected according to current MSKCC unit selection algorithm. HLA testing
to be done using molecular techniques: A and B antigen to at least intermediate
resolution and DRB1 allele at high-level resolution.

- Each unit will be at least 4/6 HLA-A, B antigen and DRB1 allele matched with the
recipient.

- In addition, each unit will have a cryopreserved dose of at least 2.0 x 10^7 total
nucleated cells/recipient body weight (TNC/kg).

- Units with attached segments for confirmatory typing will be given preference.

Exclusion Criteria:

- Diagnosis: acute leukemia in morphologic relapse or with morphologic persistent
disease (cytogenetic or molecular persistence/relapse in morphologic CR are
eligible); MDS or CML or other myeloproliferative disorder with > 5% blasts.

- Prior allogeneic transplant.

- Active and uncontrolled infection at time of transplantation.

- HIV infection.

- Inadequate performance status/ organ function.

- Pregnancy or breast feeding.

- Patient or guardian unable to give informed consent or unable to comply with the
treatment protocol including appropriate supportive care, follow-up and research
tests.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To obtain a preliminary estimate of disease-free survival at 1 year post UCBT.

Outcome Time Frame:

conclusion of study

Safety Issue:

Yes

Principal Investigator

Juliet Barker, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-087

NCT ID:

NCT00739141

Start Date:

August 2008

Completion Date:

August 2014

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndrome
  • Non-Hodgkins Lymphoma
  • Chronic Myelogenous Leukemia
  • CYCLOPHOSPHAMIDE (CYTOXAN)
  • CYCLOSPORINE A
  • FLUDARABINE
  • G-CSF
  • MYCOPHENOLATE MOFETIL (MMF)
  • THI0TEPA
  • UMBILICAL CORD BLOOD (UCB)
  • 08-087
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021