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Phase 2 N=14 Treatment

Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome · Adult Acute Lymphoblastic Leukemia in Remission · Adult Acute Megakaryoblastic Leukemia (M7) · Adult Acute Minimally Differentiated Myeloid Leukemia (M0) · Adult Acute Monoblastic Leukemia (M5a)

Enrolled (actual)
14
Serious AEs
64.3%
Results posted
Jan 2019
Primary outcome: Primary: Overall Survival — 8 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
double-unit umbilical cord blood transplantation (Procedure); cytogenetic analysis (Other); bone marrow aspiration (Procedure); fluorescence in situ hybridization (Other); busulfan (Drug); cyclophosphamide (Drug); anti-thymocyte globulin (Drug); methylprednisolone (Drug); cyclosporine (Drug); mycophenolate mofetil (Drug); flow cytometry (Other); allogeneic hematopoietic stem cell transplantation (Procedure)
Age
Pediatric, Adult · 12+ yrs
Sex
All
Sponsor
Case Comprehensive Cancer Center
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Survival
4
SECONDARY
Hematologic Engraftment
10
SECONDARY
Overall Survival
4
SECONDARY
Overall Survival
4
SECONDARY
Disease Free
4
SECONDARY
Disease Free
4
SECONDARY
Recurrence or Relapse
2
SECONDARY
Recurrence or Relapse
2
SECONDARY
Transplant Related Mortality
6
SECONDARY
Transplant Related Mortality
6
SECONDARY
Occurrence of Serious Infections
13
SECONDARY
Immune Reconstitution
SECONDARY
Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0
8
SECONDARY
Incidence of Acute Graft-versus-host Disease (GVHD)
11
SECONDARY
Incidence of Chronic GVHD
1

Summary

RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell transplant works in treating patients with hematologic malignancies.

Eligibility Criteria

Inclusion Criteria

  • Patients will be diagnosed with one of the following hematological malignancies: acute myelogenous leukemia (AML), acute lymphoblastic leukemia, non-Hodgkin's lymphoma, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and myeloproliferative and lymphoproliferative disorders
  • AML--First remission (CR1) with high risk features including a known prior diagnosis of myelodysplasia (MDS); therapy related AML; white cell count at presentation > 100,000; presence of extramedullary leukemia at diagnosis; unfavorable AML subtype (M0, M5-M7); poor cytogenetic markers (abnormalities of chromosome 5, 7 or 8, 11q23, Philadelphia chromosome, complex karyotype)
  • AML--Second remission (CR2) or subsequent remission
  • AML--Relapse/Persistent Disease with 30, 000 (T cell ALL WBC > 100,000); 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)
  • ALL--Second remission (CR2) or subsequent remission
  • ALL--Relapse/Persistent Disease with 2 units/month, poor risk cytogenetics, platelet transfusion dependence
  • MDS--Intermediate-2 or High IPSS score
  • CML--Chronic phase I (CP1) and resistant to or intolerant of tyrosine kinase inhibitors (i.e. imatinib, dasatinib, etc.)
  • CML--CP2 or subsequent chronic phase, including chronic phase achieved after induction therapy for blast crisis
  • Myeloproliferative and lymphoproliferative disorders--eligibility to be determined by a consensus of the physicians on the Case Comprehensive Cancer Center Leukemia/Lymphoma Multidisciplinary Committee
  • Myeloproliferative and lymphoproliferative disorders--must have evidence of disease acceleration to be a candidate for umbilical cord blood transplant; myeloproliferative disorders eligible for transplant include chronic myelomonocytic leukemia (CMML) with high IPSS score and myelofibrosis
  • Myeloproliferative and lymphoproliferative disorders--potential lymphoproliferative disorders eligible for transplant include chronic lymphocytic leukemia, prolymphocytic leukemia, and large granular lymphocytic leukemia
  • Good performance status: Karnofsky >= 70 % or ECOG 0-1
  • Calculated creatinine clearance >= 60 mL/min, or measured creatinine clearance >= 60 mL/min (by 24-hour urine collection) if creatinine >= 1.5 or history of renal dysfunction
  • Hepatic Transaminases 45%); if the left ventricular ejection fraction is between 40-50%, clearance by an adult cardiologist is required
  • Pulmonary function tests demonstrating FEV1 > 60% of predicted for age
  • Adults must have a DLCOva > 60% normal
  • For patients unable to complete pulmonary function tests clearance by an adult pulmonologist is required
  • Patients will be eligible for the clinical trial under the following conditions: they do NOT have an HLA-A/B/DR B1 identical RELATED bone marrow donor; they do NOT have a 6/6 HLA-identical matched unrelated adult donor; OR a matched related donor transplant is not in the best interest of the patient (i.e., patient's condition precludes waiting on the donor, too much time to prepare the donor, the donor is ineligible due to medical reasons, or in the case of high risk disease a related donor is not appropriated (syngeneic transplant); the decision must be agreed upon by the consensus of physicians on the Case Comprehensive Cancer Center Leukemia/Lymphoma Multidisciplinary Committee; OR their condition precludes waiting to search and find a donor in the National Marrow Donor Registry

Exclusion Criteria

  • Female patients who are pregnant or breast-feeding
  • HIV or HTLV-1 positivity
  • Any leukemia with a morphologic relapse or persistent disease in the BM with >= 20% blasts (cytogenetic relapse without morphologic evidence of relapse, or cytogenetic persistent disease is acceptable)
  • Active extramedullary leukemia, including CNS disease
  • Prior hematopoietic stem cell transplant (autologous or allogeneic)
  • Uncontrolled infection
  • Patient has an identical related bone mar
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01093586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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