- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00299767
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
Collaborators
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
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Myelodysplastic Syndromes
- Multiple Myeloma
Other Study ID Numbers
- 03-061
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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