Phase I Study of Sequential Cord Blood Transplants

Massachusetts General Hospital2 sites in 1 country21 target enrollmentMay 2003

ConditionsLymphoma Leukemia Multiple Myeloma Myelodysplastic Syndrome

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Lymphoma
Sponsor: Massachusetts General Hospital
Enrollment: 21
Locations: 2
Primary Endpoint: To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety of sequential cord blood transplantation (2 cord blood units) for patients who have diseases that are capable of being cured by allogeneic stem cell transplant but do not have a matched family or volunteer unrelated donor.

Detailed Description

Eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days, melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. GVHD prophylaxis will consist of cyclosporine starting on day -1 and mycophenolate mofetil starting on day 0. Sequential cord blood units will be infused on Day 0.

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

May 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Karen Ballen

Director, Leukemia Program

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

•Disease Status: NHL, HD, or MM refractory to chemotherapy or relapsed; CLL Rai Stage III/IV, or lymphocyte doubling time of 6 months, or Stage I/II resistant to 2 chemotherapy regimens; AML or ALL in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder
•Estimated disease-free survival of less than one year
•ECOG performance status of 0, 1, 2
•Lack of 6/6 or 5/6 HLA matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant
•4/6 or greater HLA A, B, CRB1 cord blood units with a combined nucleated cell dose from of \> 3.7 x 10(7) NC/kg

Exclusion Criteria

•Cardiac disease: symptomatic congestive hearth failure or RVG or echocardiogram determined left ventricular ejection fraction of \< 45%, active angina pectoris, or uncontrolled hypertension
•Pulmonary Disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of \< 50%
•Renal disease: serum creatinine \> 2.0 mg/dl
•Hepatic disease: serum bilirubin \> 2.0 mg/dl (except in the case of Gilbert's syndrome), SGPT or SGOT \> 3 x normal
•Neurologic disease: symptomatic leukoencephalopathy, active DNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
•HIV antibody or Hepatitis B surface antigen positivity
•Uncontrolled infection
•Pregnancy or breast-feeding mother

Outcomes

Primary Outcomes

To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity.

Time Frame: 3 years

Secondary Outcomes

To evaluate the 6 month transplant related (non-relapse) mortality.(3 years)
To evaluate the days to neutrophil engraftment (ANC > 500).(3 years)
To evaluate the days of platelet engraftment (platelet count > 20K unsupported).(3 years)
To evaluate the risk of acute and chronic graft versus host disease.(3 years)
To evaluate percent donor chimerism - contribution of each cord unit.(3 years)
To evaluate relapse rate.
To evaluate transfusion support needed to cord blood transplant recipients.(3 years)
To evaluate overall survival.