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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2018-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Leukemia Lymphoma Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Busulfan and fludarabine

Intravenous busulfan (Busulfan®) in combination with fludarabine

Group Type EXPERIMENTAL

Busulfan

Intervention Type DRUG

Daily intravenous dosing to target AVC

Fludarabine

Intervention Type DRUG

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

Campath

Intervention Type DRUG

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

Stem Cell Transplant

Intervention Type PROCEDURE

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

Interventions

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Busulfan

Daily intravenous dosing to target AVC

Intervention Type DRUG

Fludarabine

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

Intervention Type DRUG

Campath

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

Intervention Type DRUG

Stem Cell Transplant

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No