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Phase I Study of Sequential Cord Blood Transplants

Primary Purpose

Lymphoma, Leukemia, Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sequential cord blood transplantation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana Farber Cancer Institute
  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2006
Last Updated
May 9, 2016
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00299767
Brief Title
Phase I Study of Sequential Cord Blood Transplants
Official Title
Phase I Study of Sequential Cord Blood Transplants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Leukemia, Multiple Myeloma, Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
sequential cord blood transplantation
Intervention Description
Infused on Day 0
Primary Outcome Measure Information:
Title
To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
To evaluate the 6 month transplant related (non-relapse) mortality.
Time Frame
3 years
Title
To evaluate the days to neutrophil engraftment (ANC > 500).
Time Frame
3 years
Title
To evaluate the days of platelet engraftment (platelet count > 20K unsupported).
Time Frame
3 years
Title
To evaluate the risk of acute and chronic graft versus host disease.
Time Frame
3 years
Title
To evaluate percent donor chimerism - contribution of each cord unit.
Time Frame
3 years
Title
To evaluate relapse rate.
Title
To evaluate overall survival.
Title
To evaluate transfusion support needed to cord blood transplant recipients.
Time Frame
3 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Ballen, M.D.
Organizational Affiliation
Massachusetts General Hospital, Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Antin, M.D.
Organizational Affiliation
Dana Farber Cancer Institute, Harvard Univeristy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Avigan, M.D.
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase I Study of Sequential Cord Blood Transplants

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