NCT00597519

Brief Summary

In this study two cord blood collections will be used to increase the number of cord blood cells you will receive on transplant day. We call this a "double unit" cord blood transplant. A previous study suggests double unit cord blood transplant may have a better result. The main purpose of this study is to find out how good a cord blood transplant using two cord blood collections from two different babies is at curing you of your cancer. Double unit cord blood transplants are now being studied as a way to increase the number of cord blood cells given to bigger children and adult patients. Based on studies that have already been done double unit cord blood transplant appears to be safer than if only one cord blood unit is used. However, double unit cord blood transplant is a fairly new form of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_2 cancer

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_2 cancer

Geographic Reach
1 country

1 active site

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

March 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 12, 2016

Completed
Last Updated

February 12, 2016

Status Verified

January 1, 2016

Enrollment Period

9.5 years

First QC Date

December 26, 2007

Results QC Date

January 14, 2016

Last Update Submit

January 14, 2016

Conditions

CancerLeukemiaMyelodysplastic SyndromeNon-Hodgkin's Lymphoma

Keywords

CancerLeukemiaMyelodysplastic SyndromeNon-Hodgkin's LymphomaTotal Body IrradiationUmbilical Cord Blood Grafts06-014

Outcome Measures

Primary Outcomes (1)

  • Overall Response

    To obtain a preliminary estimate of efficacy of double unit UCBT as measured by overall response.

    1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Patients with hematopoietic malignancy at high-risk for relapse or with advanced disease will receive myeloablative conditioning with cyclophosphamide (Cy), low dose fludarabine (Flu) and total body irradiation (TBI) with post transplantation cyclosporine (CSA) and mycophenolate mofetil (MMF) for GVHD prophylaxis.

Drug: Fludarabine, CyclophosphamideProcedure: Transplantation

Interventions

Fludarabine, CyclophosphamideDRUG

Fludarabine 25 mg/m2/day IV in the morning x 3 days (days -7, -6 and -5) for a total dose of 75 mg/m2 followed by Cyclophosphamide on days -6 and -5. 60mg/kg/day IV over 30-60 minutes x 2 days (days -6 and -5). High volume fluids should commence approximately 12 hours prior to drug and continue until 24 hours after second dose. Total Body Irradiation: 125 cGy x 11 doses (TID on days -3, -2, -1 and BID on day 0) for a total TBI dose of 1375 cGy. Pediatric patients unable to tolerate a TID dosing schedule can receive 150 cGy x 8 doses (BID on days -3, -2, -1, and 0). All patients will receive GVHD prophylaxis with 2 drugs: Cyclosporine A and Mycophenolate mofetil (MMF). Units should be given consecutively each over approximately 10-30 minutes.Pre-medication should include acetaminophen and diphenhydramine or hydroxyzine.G-CSF 5 mcg/kg/day IV/SQ (dose rounded to vial size to a maximum of 480 mcg) will be given from day +1 until ANC recovery.

Treatment
TransplantationPROCEDURE

The UCB ( Umbilical Cord Blood) collection known as a unit is processed to remove excess plasma and red cells, tested for sterility, HLA-typed, cryopreserved and stored. This protocol involves the administration of two UCB units from two different donors. The units will be thawed in the Cytotherapy Laboratory as per the current standard operating procedure.

Treatment

Eligibility Criteria

Age4 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 4 - 50 years
  • Patient should not have a related or unrelated volunteer donor that is suitably HLA matched and available in the required time period or be a suitable candidate for an autologous stem cell transplant.
  • Patients will have one of the following hematological malignancies: Acute myelogenous leukemia (AML):
  • Complete first remission (CR1) at high risk for relapse as defined by:
  • known prior diagnosis of myelodysplasia (MDS); or therapy related AML; or White cell count at presentation \> 100,000; or Presence of extramedullary leukemia at diagnosis; or Unfavorable FAB type (M0, M5-7); or High-risk cytogenetics (such as those associated with MDS, abnormalities of 5, 7, 8, Philadelphia chromosome, complex karyotype); or High risk molecular markers such as FLT3 mutations; or Requirement for 2 or more inductions to achieve CR1
  • Complete second CR (CR2).
  • Acute lymphoblastic leukemia (ALL):
  • Complete first remission (CR1) at high risk for relapse as defined by:
  • White cell count at presentation as follows:
  • \> 100,000 if \< 18 years
  • \> 50,000 if \> 18 years; or
  • Presence of extensive extra-medullary disease (excluding CNS disease); or Presence of high-risk cytogenetic abnormality such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23), t(8;14) \[excluding B-ALL in pediatric patients\]; or
  • Failed to achieve complete remission after four weeks of induction therapy Unable to receive required consolidation chemotherapy as would be needed to maintain remission
  • Complete second or third remission (CR2 or CR3)
  • Acute undifferentiated leukemia (AUL), infant leukemia, or biphenotypic leukemia in CR1, CR2 or CR3. Patients with infant leukemia must be eligible to receive total body irradiation.
  • +41 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsLeukemiaMyelodysplastic SyndromesLymphoma, Non-Hodgkin

Interventions

fludarabineCyclophosphamideTransplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Juliet Barker
Organization
Memorial Sloan Kettering Cancer Center
barkerj@mskcc.org
212-639-3468

Study Officials

  • Juliet Barker, MBBS

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 18, 2008

Study Start

March 1, 2006

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 12, 2016

Results First Posted

February 12, 2016

Record last verified: 2016-01

Locations

US(1)