NCT00295880 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2017-12-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Median Number of Days to Neutrophil Engraftment

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outcome · POSTED

Number of Patients Achieving Neutrophil Recovery

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outcome · POSTED

Number of Patients With Evidence of Engraftment.

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outcome · POSTED

Number of Patients With Acute Graft-versus-host Disease (GVHD)

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outcome · POSTED

Number of Patients With Transplant-related Mortality (TRM)

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outcome · POSTED

Number of Patients Surviving at Day 100 and 1 Year.

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outcome · POSTED

Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)

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outcome · POSTED

Number of Patients With Chronic Graft-versus-host Disease (GVHD).

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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.
healthy Volunteers: false
maximum Age: 45 Years
minimum Age: 12 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
Patients receiving umbilical cord blood transplantation.
intervention Names
Procedure: umbilical cord blood transplantation
label
Transplant Patients
type
EXPERIMENTAL

interventions

arm Group Labels
Transplant Patients
description
The graft will be given by slow injection into each posterior iliac crest.
name
umbilical cord blood transplantation
other Names
UCBT
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 12
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Median Number of Days to Neutrophil Engraftment
time Frame
Daily through Day 60 post transplant

secondary Outcomes

description
Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.
measure
Number of Patients Achieving Neutrophil Recovery
time Frame
6 months
description
Number of patients who received both cord blood units and achieved sustained donor engraftment
measure
Number of Patients With Evidence of Engraftment.
time Frame
1 year
description
Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.
measure
Number of Patients With Acute Graft-versus-host Disease (GVHD)
time Frame
100 days post transplant
description
Number of patients who were deceased at days 100 and 180 from any cause other than relapse.
measure
Number of Patients With Transplant-related Mortality (TRM)
time Frame
Day 100 and Day 180
description
Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.
measure
Number of Patients Surviving at Day 100 and 1 Year.
time Frame
Day 100 and 1 year
description
Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.
measure
Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)
time Frame
100 days post transplant
description
Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.
measure
Number of Patients With Chronic Graft-versus-host Disease (GVHD).
time Frame
1 year post transplant

Full study description

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.

Source references

references

citation
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.
pmid
19139736
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice