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

Phase 1

Completed

• Conditions: Lymphoma; Leukemia; Myeloma
• Interventions: Drug: Busulfan; Drug: Fludarabine; Drug: Campath; Procedure: Stem Cell Transplant

• Registration Number: NCT00943319
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-20
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Study Start: 2012-03
• Primary Completion: 2017-12
• Results First Submitted: 2018-10-09
• Study Completion: 2018-12
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-01
• Last Update Submitted: 2019-02-01
• Results First Posted: 2019-02-04
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Busulfan and fludarabine	Campath	Intravenous busulfan (Busulfan®) in combination with fludarabine
Busulfan and fludarabine	Stem Cell Transplant	Intravenous busulfan (Busulfan®) in combination with fludarabine
Busulfan and fludarabine	Fludarabine	Intravenous busulfan (Busulfan®) in combination with fludarabine
Busulfan and fludarabine	Busulfan	Intravenous busulfan (Busulfan®) in combination with fludarabine

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	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 Outcome Measures

Name	Time	Method
Disease Free Survival	5 years	Disease Free Survival measured by median survival time in days
Overall Survival	5 years	Overall Survival measured as median survival in days

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States