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

NCT ID: NCT00295880

Last Updated: 2017-12-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2008-08-31

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.

Conditions

Myeloproliferative Disorders; Leukemia; Lymphoma; Myelodysplastic Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transplant Patients

Patients receiving umbilical cord blood transplantation.

Group Type: EXPERIMENTAL

umbilical cord blood transplantation

Intervention Type: PROCEDURE

The graft will be given by slow injection into each posterior iliac crest.

Interventions

umbilical cord blood transplantation

The graft will be given by slow injection into each posterior iliac crest.

Intervention Type: PROCEDURE

Other Intervention Names

UCBT

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John E. Wagner, MD

Role: STUDY_CHAIR

Masonic Cancer Center, University of Minnesota

References

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.

Reference Type: RESULT

PMID: 19139736 (View on PubMed)

Other Identifiers

UMN-MT2004-26

Identifier Type: OTHER

Identifier Source: secondary_id

UMN-0412M65789

Identifier Type: OTHER

Identifier Source: secondary_id

2004LS072

Identifier Type: -

Identifier Source: org_study_id