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Completed

NCT Number: NCT00943319

Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies

The purpose of this study is:

1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. 2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). 3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen. 4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Phase I portion:

  • Relapsed or refractory acute myelogenous or lymphoid leukemia.
  • Chronic myelogenous leukemia in accelerated phase or blast-crisis.
  • Recurrent or refractory malignant lymphoma or Hodgkin's disease
  • Recurrent or refractory multiple myeloma.
  • Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
  • Myeloproliferative disorder (polycythemia vera, myelofibrosis) with transformation
  • Myelodysplastic syndromes with more than 5% blasts.

Phase II portion:

  • AML with active disease or beyond CR2.
  • MDS with more than 5% blasts.

Exclusion criteria

  • Clinical progression. Such patients may be treated on other treatment protocols or at the investigator's discretion. Such patients will continue to be monitored for survival and, may be asked to continue to provide specimens for studies of minimal residual disease and immune reconstitution as other treatments are recommended.

Treatment and study plan

busulfan

Drug

Daily intravenous dosing to target AVC

Fludarabine

Drug

Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.

Campath

Drug

All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).

Stem Cell Transplant

Procedure

Infusion of bone marrow and donors(related/ unrelated).

Primary outcomes

  1. Maximum Tolerated Dose

    Time frame: 5 years

    Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.

Secondary outcomes

  1. Overall Survival

    Time frame: 5 years

    Overall Survival measured as median survival in days

  2. Disease Free Survival

    Time frame: 5 years

    Disease Free Survival measured by median survival time in days

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

A Phase I-II Study of Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Jul 22, 2009
Registry last updated
Feb 4, 2019

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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