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Completed

NCT Number: NCT00202917

Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies

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.

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Key information

Conditions

Hematologic Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Dresden Medical Center, Dresden, Germany

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About this study

Transplantation of a CD3/CD19 depleted stem cell grafts after dose reduced conditioning for the treatment of treatment refractory or relapsed hematologic malignancies after preceding allogeneic or autologous hematopoietic cell transplantation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • HD
  • CML
  • MM
  • No HLA-identical MRD or URD if not preceding allo-HCT
  • Use haploidentical donor with KIR-Mismatch if choice

Exclusion criteria

  • < 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

Treatment and study plan

Fludarabine

Drug

Thiotepa

Drug

melphalan

Drug

OKT-3

Drug

CD3/CD19 depletion on CliniMACS

Procedure

Primary outcomes

  1. Engraftment

  2. Toxicity

  3. Mortality and Morbidity

Secondary outcomes

  1. Infections

  2. GVHD

  3. Immune reconstitution

  4. Disease response

  5. Long term toxicity

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Multicenter Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies

Important dates

Study start
2004
Primary completion
2009
Study completion
2010
First posted
Sep 20, 2005
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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