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| ID | Type | Description | Link |
|---|---|---|---|
| UMN-MT2004-26 | Other Identifier | Blood and Bone Marrow Transplant Program | |
| UMN-0412M65789 | Other Identifier | IRB at University of Minnesota |
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Time to engraftment would not be improved compared to historical controls.
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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.
Objectives:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplant Patients | Experimental | Patients receiving umbilical cord blood transplantation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord blood transplantation | Procedure | The graft will be given by slow injection into each posterior iliac crest. |
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| Measure | Description | Time Frame |
|---|---|---|
| Median Number of Days to Neutrophil Engraftment | 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. | Daily through Day 60 post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Neutrophil Recovery | Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months. | 6 months |
| Number of Patients With Evidence of Engraftment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John E. Wagner, MD | Masonic Cancer Center, University of Minnesota | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19139736 | Result | 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. |
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Patients are recruited from within the Department of Blood and Marrow Transplant Program. (Patients will be co-enrolled on study MT2005-10 (NCT00309842). Eligibility for this study are identical to MT2005-10.)
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| ID | Title | Description |
|---|---|---|
| FG000 | Umbilical Cord Blood Transplant Patients | Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Number of patients who received both cord blood units and achieved sustained donor engraftment
| 1 year |
| Number of Patients With Acute Graft-versus-host Disease (GVHD) | Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant. | 100 days post transplant |
| Number of Patients With Transplant-related Mortality (TRM) | Number of patients who were deceased at days 100 and 180 from any cause other than relapse. | Day 100 and Day 180 |
| Number of Patients Surviving at Day 100 and 1 Year. | Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant. | Day 100 and 1 year |
| Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) | Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant. | 100 days post transplant |
| Number of Patients With Chronic Graft-versus-host Disease (GVHD). | Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD. | 1 year post transplant |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Umbilical Cord Blood Transplant Patients | Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Number of Days to Neutrophil Engraftment | 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. | Posted | Jul 2009 | Median | Full Range | Days | Daily through Day 60 post transplant |
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| Secondary | Number of Patients Achieving Neutrophil Recovery | Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months. | Patients who completed treatment. | Posted | Jul 2009 | Number | Participants | 6 months |
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| Secondary | Number of Patients With Evidence of Engraftment. | Number of patients who received both cord blood units and achieved sustained donor engraftment | 1 patient was not evaluable due to graft failure | Posted | Jul 2009 | Number | Participants | 1 year |
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| Secondary | Number of Patients With Acute Graft-versus-host Disease (GVHD) | Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant. | 2 patients were not graded for acute GVHD due to graft failure. | Posted | Jul 2009 | Number | Participants | 100 days post transplant |
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| Secondary | Number of Patients With Transplant-related Mortality (TRM) | Number of patients who were deceased at days 100 and 180 from any cause other than relapse. | Posted | Jul 2009 | Number | Participants | Day 100 and Day 180 |
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| Secondary | Number of Patients Surviving at Day 100 and 1 Year. | Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant. | Posted | Jul 2009 | Number | Participants | Day 100 and 1 year |
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| Secondary | Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) | Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant. | 2 patients were not yet graded for acute gvhd | Posted | Jul 2009 | Number | Participants | 100 days post transplant |
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| Secondary | Number of Patients With Chronic Graft-versus-host Disease (GVHD). | Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD. | Only 7 patients were at risk for chronic GVHD | Posted | Jul 2009 | Number | Participants | 1 year post transplant |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Umbilical Cord Blood Transplant Patients | Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection. | 5 | 12 | 0 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| graft failure | Blood and lymphatic system disorders | Systematic Assessment |
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| Acute GVHD Grade 3 | Blood and lymphatic system disorders | Systematic Assessment |
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| Death | General disorders | Non-systematic Assessment |
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This study was terminated early based on interim statistical analysis that indicated time to engraftment will not be improved compared to historical controls. While safe, lack of faster marrow recovery supports early discontinuation.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John E. Wagner, M.D. | Masonic Cancer Center, University of Minnesota Blood and Marrow Transplant Program | 612-626-2961 | wagne002@umn.edu |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D000753 | Anemia, Refractory |
| D000095542 | Cytopenia |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D001752 | Blast Crisis |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D015467 | Leukemia, Neutrophilic, Chronic |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000740 | Anemia |
| D016393 | Lymphoma, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
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| ID | Term |
|---|---|
| D036101 | Cord Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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