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

This study has been terminated.
(Time to engraftment would not be improved compared to historical controls.)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00295880
First received: February 23, 2006
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Myeloproliferative Disorders
Leukemia
Lymphoma
Myelodysplastic Syndromes
Procedure: umbilical cord blood transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Median Number of Days to Neutrophil Engraftment [ Time Frame: Daily through Day 60 post transplant ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Patients Achieving Neutrophil Recovery [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.


Enrollment: 12
Study Start Date: June 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transplant Patients
Patients receiving umbilical cord blood transplantation.
Procedure: umbilical cord blood transplantation
The graft will be given by slow injection into each posterior iliac crest.
Other Name: UCBT

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.

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295880

Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: John E. Wagner, MD Masonic Cancer Center, University of Minnesota
  More Information

Publications:
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00295880     History of Changes
Other Study ID Numbers: 2004LS072, UMN-MT2004-26, UMN-0412M65789
Study First Received: February 23, 2006
Results First Received: March 25, 2009
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Lymphoma
Leukemia
Syndrome
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014