A Phase I/II Study of Double Unit Umbilical Cord Blood (UCB) Transplantation Utilizing Graft Administration Via Intra-Bone Marrow Injection (Companion Protocol to MT2000-25)
12 Years
45 Years
Both
Myeloproliferative Disorders, Leukemia, Lymphoma, Myelodysplastic Syndromes
Trial Information
A Phase I/II Study of Double Unit Umbilical Cord Blood (UCB) Transplantation Utilizing Graft Administration Via Intra-Bone Marrow Injection (Companion Protocol to MT2000-25)
Objectives:
Primary
- Determine the safety, in terms of infusional toxicity, of myeloablative unrelated donor
double-unit umbilical cord blood (UCB) transplantation via intra-bone marrow injection
(IBMI) in patients with advanced or high-risk hematologic malignancy.
- Determine whether treatment with this regimen improves the time to neutrophil
engraftment (compared to historical controls) in these patients.
Secondary
- Determine the incidence of sustained donor engraftment in patients treated with this
regimen.
- Determine the relative contribution of each UCB unit to initial and sustained donor
engraftment in these patients.
- Determine the incidence of grade II-IV and grade III-IV acute graft-vs-host disease
(GVHD) and chronic GVHD in patients treated with this regimen.
- Determine the incidence of day 100 and 180 transplant-related mortality in patients
treated with this regimen.
- Determine the probability of survival at 100 days and 1 year post-transplantation in
these patients.
Outline: This is a nonrandomized study.
Patients receive a myeloablative conditioning regimen. Patients also receive
immunosuppression, growth factor, and supportive care as in protocol MT2005-10
(NCT00309842).
Patients receive 2 units of donor umbilical cord blood (UCB) by intra-bone marrow injection
(IBMI) over 10 minutes each on day 0. If the IBMI procedure is not possible, then the UCB
units are given intravenously (IV.)
After completion of study therapy, patients are followed periodically for 5 years.
Projected Accrual: A total of 36 patients will be accrued for this study.
Inclusion Criteria:
- Acute myeloid leukemia (AML): high risk CR1
- Acute lymphocytic leukemia (ALL): high risk CR1 [t(9;22), t (1:19), t(4;11) or other
MLL rearrangements] or > 1 cycle to obtain CR; CR2+. All patients must be in CR as
defined by hematological recovery, AND <5% blasts by light microscopy within the bone
marrow with a cellularity of ≥15%.
- Chronic myelogenous leukemia (CML) excluding refractory blast crisis. To be eligible
in first chronic phase (CP1) patient must have failed or be intolerant to imatinib
mesylate.
- Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia
with severe pancytopenia or high risk cytogenetics.
- Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone
B-cell lymphoma or follicular lymphoma that have progressed after at least two prior
therapies. Patients with bulky disease (nodal mass greater than 5 cm).
- Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are
eligible after initial therapy in CR1+ or PR1+.
- Large cell NHL > CR2/> PR2. Patients in CR2/PR2 with initial short remission (<6
months) are eligible.
- Lymphoblastic lymphoma.
- Multiple myeloma beyond PR2.
- Karnofsky performance status (PS) 90-100% (adults)
- Lansky PS 50-100% (children)
- Acceptable organ function
Exclusion Criteria:
- Active infection at time of transplantation
- History of HIV infection
- Pregnant or breast feeding.
- Chemotherapy refractory large cell and high grade NHL (ie progressive disease after >
2 salvage regimens)
- Extensive prior therapy including > 12 months alkylator therapy or > 6 months
alkylator therapy with extensive radiation.
- Diffuse myelofibrosis of BM (bone marrow) (any severity) regardless of primary
diagnosis (focal fibrosis acceptable provided it involves < 20% of BM volume).
- History of pelvic irradiation.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Median Number of Days to Neutrophil Engraftment
Outcome Description:
Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.
Outcome Time Frame:
Daily through Day 60 post transplant
Safety Issue:
Yes
Principal Investigator
John E. Wagner, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Institutional Review Board
Study ID:
2004LS072
NCT ID:
NCT00295880
Start Date:
June 2005
Completion Date:
August 2008
Related Keywords:
- Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Myelodysplastic Syndromes
- adult acute myeloid leukemia in remission
- adult acute myeloid leukemia
- childhood acute myeloid leukemia in remission
- secondary acute myeloid leukemia
- accelerated phase chronic myelogenous leukemia
- childhood chronic myelogenous leukemia
- chronic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- refractory anemia with excess blasts
- de novo myelodysplastic syndromes
- myelodysplastic syndromes
- adult diffuse large cell lymphoma
- adult diffuse mixed cell lymphoma
- adult diffuse small cleaved cell lymphoma
- adult lymphoblastic lymphoma
- grade 3 follicular lymphoma
- mantle cell lymphoma
- childhood large cell lymphoma
- childhood lymphoblastic lymphoma
- adult acute lymphoblastic leukemia
- acute lymphoblastic leukemia
- refractory anemia
- refractory cytopenia
- childhood acute myeloid leukemia
- adult immunoblastic large cell lymphoma
- blastic phase chronic myelogenous leukemia
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- childhood small noncleaved cell lymphoma
- childhood myelodysplastic syndromes
- Leukemia
- Lymphoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
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