NCT00299767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 lymphoma

Timeline
Completed

Started May 2003

Typical duration for phase_1 lymphoma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

March 3, 2006

Last Update Submit

May 9, 2016

Conditions

LymphomaLeukemiaMultiple MyelomaMyelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Interventions

sequential cord blood transplantationPROCEDURE

Infused on Day 0

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • /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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02116, United States

Location

MeSH Terms

Conditions

LymphomaLeukemiaMultiple MyelomaMyelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow Diseases

Study Officials

  • Karen Ballen, M.D.

    Massachusetts General Hospital, Harvard University

    PRINCIPAL INVESTIGATOR

  • Joseph Antin, M.D.

    Dana Farber Cancer Institute, Harvard Univeristy

    PRINCIPAL INVESTIGATOR

  • David Avigan, M.D.

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Leukemia Program

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 7, 2006

Study Start

May 1, 2003

Primary Completion

May 1, 2005

Study Completion

May 1, 2009

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

US(2)