NCT00202917

Brief Summary

The purpose of this study is to study the feasibility and Toxicity of allogeneic haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a dose reduced conditioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_1

Geographic Reach
1 country

7 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

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

5.4 years

First QC Date

September 12, 2005

Last Update Submit

May 28, 2014

Conditions

Hematologic Malignancies

Keywords

haploidentical transplantationimmunomagnetic cell sortingallogeneic hematopoietic cell transplantationdose reduced conditioning

Outcome Measures

Primary Outcomes (3)

  • Engraftment

  • Toxicity

  • Mortality and Morbidity

Secondary Outcomes (5)

  • Infections

  • GVHD

  • Immune reconstitution

  • Disease response

  • Long term toxicity

Interventions

FludarabineDRUG
ThiotepaDRUG
MelphalanDRUG
OKT-3DRUG
CD3/CD19 depletion on CliniMACSPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \<60, \>18 years
  • Karnofsky \>60%
  • High risk hematologic malignancy or relapse after preceding auto/allo HCT in patients with:
  • ALL
  • AML
  • PNH
  • MDS (RAEB-t/secondary AML)
  • NHL
  • ALL
  • CML
  • No HLA-identical MRD or URD if not preceding allo-HCT
  • Use haploidentical donor with KIR-Mismatch if choice

You may not qualify if:

  • \< 3 months after preceding HCT
  • Active cerebral seizures
  • \> 30% blasts in BM if ALL/AML/CML-BC
  • Completely chemo-refractory
  • Preceding myocardial infarction
  • Ejection fraction \<30 % echocardiography
  • Creatinine clearance \<50 ml/min
  • Respiratory insufficiency on supplemental O2 or DLCO \< 30%
  • Allergy against murine antibodies
  • HIV infection
  • Pregnancy
  • Unable for informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Dresden Medical Center

Dresden, D-01307, Germany

Location

Center for Marrow Transplantation

Essen, 45122, Germany

Location

Medical Center University of Hamburg

Hamburg, 20246, Germany

Location

Medical Center University of Muenster

Münster, 48129, Germany

Location

South West German Cancer Center, University of Tuebingen Medical Center

Tübingen, 72076, Germany

Location

Deutsche Klinik für Diagnostik

Wiesbaden, 65191, Germany

Location

University of Wuerzburg Medical Center

Würzburg, D-97070, Germany

Location

Related Publications (1)

  • Federmann B, Bornhauser M, Meisner C, Kordelas L, Beelen DW, Stuhler G, Stelljes M, Schwerdtfeger R, Christopeit M, Behre G, Faul C, Vogel W, Schumm M, Handgretinger R, Kanz L, Bethge WA. Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning: a phase II study. Haematologica. 2012 Oct;97(10):1523-31. doi: 10.3324/haematol.2011.059378. Epub 2012 Apr 4.

    PMID: 22491731DERIVED

Related Links

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

fludarabineThiotepaMelphalan

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PhosphoramidesOrganophosphorus CompoundsOrganic ChemicalsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Wolfgang A Bethge, MD

    University of Tuebingen Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 2004

Primary Completion

July 1, 2009

Study Completion

December 1, 2010

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

DE(7)