NCT00587054

Brief Summary

This is a phase II, single-center study to evaluate the efficacy of a novel cytoreductive regimen followed by CD34+E- selected T cell depleted allogeneic stem cell (or soybean agglutinated and E-rosetted BM) transplant as treatment for patients with acute and chronic leukemias, lymphoma and myelodysplstic syndrome/PNH. The impact of the change in conditioning regimen and use of CD34-selected T cell depleted PBSCs on transplanted related morbidity and mortality and disease free survival will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_2

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

June 1, 2001

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

March 10, 2017

Completed
Last Updated

March 10, 2017

Status Verified

January 1, 2017

Enrollment Period

9.9 years

First QC Date

December 21, 2007

Results QC Date

December 22, 2015

Last Update Submit

January 20, 2017

Conditions

Allogeneic Stem Cell TransplantLeukemiaNon-HodgkinsLymphoblastic LymphomaMyelodysplastic SyndromeParoxysmal Nocturnal Hemoglobinuria (PNH)

Keywords

leukemianon-Hodgkinslymphoblastic lymphomamyelodysplastic syndromeparoxysmal nocturnal hemoglobinuria (PNH)cytoreductive regimenallogeneic stem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Overall Survival of Transplant Patients

    Calculate the median overall survival of transplant patients

    up to 6 years

Study Arms (1)

Transplant Patients

EXPERIMENTAL
Drug: cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant

Interventions

cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplantDRUG

Myeloablative and will consist of hyperfractionated TBI - 1375 cGy administered in 11 doses of 125 cGy each over a total of four days, with three doses on three days and two doses on the last day, fludarabine 25 mg/m2 IV x 5 days, and thiotepa 5mg/kg IV x 2 days. Recipients of HLA identical related transplants will not receive ATG to promote engraftment. Recipients of HLA mismatched related or unrelated stem cells will receive ATG for two days prior to the transplant. G-CSF mobilized CD34+E- PBSCs obtained from the HLA compatible donor will be infused on day 0. Post transplantation G-CSF will be administered only if clinically indicated and should begin on or after d+7. Patients will be clinically evaluated at each clinic visit for incidence and severity of acute and chronic GVHD and transplant associated morbidity. Sequential evaluation of functional reconstitution of hematopoiesis and immunity will be made as per the BMT Service guidelines.

Transplant Patients

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Histologically proven acute or chronic leukemia, non Hodgkins and lymphoblastic lymphoma or myelodysplastic syndrome
  • HLA 6/6 or 5/6 antigen matched related or unrelated donor
  • creatinine = normal or if not, CrCl \> 60 ml/min/1.73ml
  • total bilirubin \< 2.5, AST \< 2xnl, cardiac function \> 50%
  • pulmonary function - asymptomatic or if not DLCO \> %50% (corrected for Hgb)
  • Karnofsky performance status \> 70%
  • negative pregnancy test (where applicable)
  • signed informed consent of patient and donor.

You may not qualify if:

  • Pregnancy or lactation
  • unwillingness to comply with protocol treatment or follow-up
  • uncontrolled infection
  • HIV or HTLV positivity
  • active CNS/skin disease

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

LeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaMyelodysplastic SyndromesHemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesAnemia, HemolyticAnemia

Results Point of Contact

Title
Dr. Ann Jakubowski
Organization
Memorial Sloan-Kettering Cancer Center
jakubowa@mskcc.org
212-639-5013

Study Officials

  • Ann Jakubowski, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

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 21, 2007

First Posted

January 7, 2008

Study Start

June 1, 2001

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 10, 2017

Results First Posted

March 10, 2017

Record last verified: 2017-01

Locations

US(1)