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Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00295880
Recruitment Status : Terminated (Time to engraftment would not be improved compared to historical controls.)
First Posted : February 24, 2006
Results First Posted : September 3, 2009
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date  ICMJE February 23, 2006
First Posted Date  ICMJE February 24, 2006
Results First Submitted Date  ICMJE March 25, 2009
Results First Posted Date  ICMJE September 3, 2009
Last Update Posted Date December 28, 2017
Study Start Date  ICMJE June 2005
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2009)
Median Number of Days to Neutrophil Engraftment [ Time Frame: Daily through Day 60 post transplant ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2009)
  • Number of Patients Achieving Neutrophil Recovery [ Time Frame: 6 months ]
    Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.
  • Number of Patients With Evidence of Engraftment. [ Time Frame: 1 year ]
    Number of patients who received both cord blood units and achieved sustained donor engraftment
  • Number of Patients With Acute Graft-versus-host Disease (GVHD) [ Time Frame: 100 days post transplant ]
    Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.
  • Number of Patients With Transplant-related Mortality (TRM) [ Time Frame: Day 100 and Day 180 ]
    Number of patients who were deceased at days 100 and 180 from any cause other than relapse.
  • Number of Patients Surviving at Day 100 and 1 Year. [ Time Frame: Day 100 and 1 year ]
    Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.
  • Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) [ Time Frame: 100 days post transplant ]
    Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.
  • Number of Patients With Chronic Graft-versus-host Disease (GVHD). [ Time Frame: 1 year post transplant ]
    Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer
Official Title  ICMJE 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)
Brief Summary

Rationale: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant 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 healthy stem cells from the donor's umbilical cord blood are injected into the patient's bone marrow they may help make stem cells, red blood cells, white blood cells, and platelets.

Purpose: This phase I/II trial is studying the side effects of donor umbilical cord blood transplant when given directly into the bone marrow and to see how well it works in treating patients with hematologic cancer.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
Intervention  ICMJE Procedure: umbilical cord blood transplantation
The graft will be given by slow injection into each posterior iliac crest.
Other Name: UCBT
Study Arms  ICMJE Experimental: Transplant Patients
Patients receiving umbilical cord blood transplantation.
Intervention: Procedure: umbilical cord blood transplantation
Publications * Brunstein CG, Barker JN, Weisdorf DJ, Defor TE, McKenna D, Chong SY, Miller JS, McGlave PB, Wagner JE. Intra-BM injection to enhance engraftment after myeloablative umbilical cord blood transplantation with two partially HLA-matched units. Bone Marrow Transplant. 2009 Jun;43(12):935-40. doi: 10.1038/bmt.2008.417. Epub 2009 Jan 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 2, 2009)
12
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00295880
Other Study ID Numbers  ICMJE 2004LS072
UMN-MT2004-26 ( Other Identifier: Blood and Bone Marrow Transplant Program )
UMN-0412M65789 ( Other Identifier: IRB at University of Minnesota )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: John E. Wagner, MD Masonic Cancer Center, University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP