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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943319
• Other study ID #: 12-0132
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2012
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Myeloma

Intervention

Drug:
• Busulfan
Daily intravenous dosing to target AVC
• Fludarabine
Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.
• Campath
All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).

Procedure:
• Stem Cell Transplant
Infusion of bone marrow and donors(related/ unrelated).

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose	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.	5 years
Secondary	Overall Survival	Overall Survival measured as median survival in days	5 years
Secondary	Disease Free Survival	Disease Free Survival measured by median survival time in days	5 years