Phase I Study of Sequential Cord Blood Transplants

May 9, 2016 updated by: Karen Ballen, Massachusetts General Hospital
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02116
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity.
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joseph Antin, M.D., Dana Farber Cancer Institute, Harvard Univeristy
  • Principal Investigator: David Avigan, M.D., Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (ACTUAL)

May 1, 2005

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

March 3, 2006

First Submitted That Met QC Criteria

March 3, 2006

First Posted (ESTIMATE)

March 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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